Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Online Pharmacy Regulation in India

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Pharma sector regulations

Mains level : E pharmacy and its benefits

In the last week, India’s online pharmacy market saw two significant merger and acquisition deals. This has suddenly caused activity in a sector from which large investors have shied away due to lack of proper regulations.

Try this easy question:

Q. Discuss the prospects and benefits of online pharmacy in India. (150W)

How is the pharmacy market in India currently shaped?

  • Unlike the US, where the top three pharmaceutical distributors have a 90 per cent share in the market, India’s is a fragmented market with over 8 lakh pharmacies.
  • This gives online pharmacies an opportunity to capture their space without opposing large traditional retailers.
  • Currently, companies in the Indian e-pharmacy space mainly operate three business models — marketplace, inventory-led hybrid (offline/online) and franchise-led hybrid (offline/online) — depending on the way the supply chain is structured.

Rules governing the pharma sector

  • Work on regulations specifically for e-pharmacies has been in progress for several years now.
  • In the absence of clear regulations, online pharmacies currently operate as marketplaces and cater to patients as a platform for ordering medicines from sellers that adhere to the Drugs and Cosmetics Act and Rules of India.
  • Other regulations, like the Information Technology Act and the Narcotic Drugs and Psychotropic Substances Act, also apply.

What do the draft e-pharmacy regulations propose?

  • Draft rules for e-pharmacies sought to define the online sale of medicines, what an e-prescription means and what type of licences online firms would need to get from regulators to operate.
  • The draft had proposed to allow e-pharmacies to get a central licence to operate from the country’s apex drug regulator, which could be used to allow it to operate across the country.
  • It also proposed to define e-pharmacies in a way that would allow them to distribute, sell and stock medicines.
  • The proposed regulations prevent them from selling habit-forming drugs like cough syrups specified in Schedule X of the Indian drug regulations.

Current status

  • Regulations for online pharmacy players have been in the works since 2016 but are yet to come out.
  • The last attempt to clear these regulations saw the draft rules being pushed through two expert committees under the Central Drugs Standard Control Organisation–India’s apex drug regulatory body–in June 2019.

Online pharma is growing in scale

  • While Covid-19 and the subsequent behavioural shift towards e-commerce may have catalyzed growth for online pharmacies, the sector was already poised to grow seven-fold by 2023 to $2.7 billion.
  • This was mainly on account of the challenges faced by physical pharmacies that gave their online counterparts a problem to solve.
  • Experts believe that e-pharmacies will be able to solve the problems that traditional pharmacies couldn’t.
  • But for this, they need to have a large-scale presence that calls for either huge investments or consolidation.

Conclusion

  • The e-pharmacy sector holds immense potential to address the persisting issue of affordability and accessibility of medicines in India.
  • Steps should be taken to foster the e-pharmacy sector with sufficient safeguards and under regulatory control to protect the interest of the consumers.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Drug pricing and dependence on China

Note4Students

From UPSC perspective, the following things are important :

Prelims level : APIs, NLEM

Mains level : Paper 3-Issue of India's dependence on China for APIs.

Whether or not the drug pricing system in India resulted in the growing dependence on China for APIs is analysed in this article. 

Incentives for domestic production of APIs

  • The department of pharmaceuticals (DoP) has recently notified the Production-Linked Incentive (PLI) scheme.
  • The scheme aims to encourage domestic production of 41 active pharmaceutical ingredients (APIs), key starting materials (KSMs) and drug intermediaries (DIs).
  • A Drug Security Committee constituted by the DoP had identified 53 APIs with high dependence on China.

Did drug price control policy increase dependence on China?

  • India was self-reliant on APIs until the mid-1990s.
  • Liberalisation in import restrictions led to a gradual influx of APIs from China.
  • India had a more stringent price control policy before the 1990s.
  • If price control system were the culprit, India would not have been self-sufficient in APIs until the mid-1990s.
  • A cost-based price control system that existed until 2013 regulated the prices of both APIs and formulations.
  • The approach to price control shifted from a cost-based to a market-based one since 2013.
  • The new price control policy does not regulate the price of APIs.
  • New price control policy regulates the prices of formulations of those APIs, which figure in the National List of Essential Medicines (NLEM).
  • There are many APIs which do not fall under DPCO but are still imported in a significant way from China.

Understanding the growing dependence on China from the past perspective

  • Even though India now has a less stringent drug price control policy, the dependence on Chinese imports has been growing.
  • The share of China in India’s total import of APIs has increased from 61% in 2011 to 69% in 2019.
  • The experience in India was that firms would tend to rely on imported APIs if they have an option.
  • The Hathi Committee (1975), which had looked into why Indian firms were not engaging in the production of APIs, found that the capital invested to turnover ratio of APIs was much lower as compared to formulations.
  • This ratio was 1:1 for APIs at best and 1:2.6 for formulations on average, and in some cases, as high as 1:7.2.
  • Subsequently, various measures were adopted.
  • The ‘ratio parameter’ mandatorily required the producers of formulations to produce a certain quantity of APIs.
  • It was the government interventions to overcome the market failure that resulted in India attaining self-sufficiency in APIs.

Consider the question “What are the APIs? Examine the implications of India’s dependence on imports for API and suggest the measures to reduce such dependence.”

Conclusion

An enquiry into the causes of dependence on China needs to go much beyond price control policy and look into whether the state continued to play a proactive role during the post-1991 period to maintain an ecosystem to enhance the competence of Indian API industry.


Source-

https://www.financialexpress.com/opinion/drug-pricing-is-certainly-not-the-issue-in-growing-dependence-on-china/2046086/

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Decoupling pharmaceutical industry from China should be strategic

Note4Students

From UPSC perspective, the following things are important :

Prelims level : APIs

Mains level : Paper 3- Indian pharmaceutical industry

Abrupt ban on import from China would harm the India pharmaceutical industry and disrupt the supply of several essential medicines. Any attempt at reducing the dependence on China for APIs should be strategies, argues the author.

Dependence of Indian pharma industry on China

  •  India is the third-largest producer of finished drugs in the world.
  • However, India relies significantly on China for supplies of active pharmaceutical ingredients APIs.
  • An estimated 70 per cent of API requirements of India’s pharmaceutical industry are sourced from China.
  • For some drugs, such as paracetamol and ibuprofen, this dependence is almost 100 per cent.
  • This import reliance has been fuelled by environmental controls in India and competition with China, which has higher volumes of production and lower costs.

Implications of banning import from China

  • Restricting or banning the import of APIs would cause significant disruption to the Indian pharmaceutical industry
  • The pharmaceutical industry had $40 billion in revenues in 2018-19, according to Pharmexcil.
  • Such a prospect is especially of concern to potential patients.
  •  Indian pharmaceutical industry annually exports $20 billion worth of medicine.
  • An ad hoc or reactive decoupling could disrupt the production of a wide range of medicines in India and globally.
  • Such disruption could affect the availability of Dexamethasone and painkillers, such as paracetamol and ibuprofen, as well as antibiotics, such as penicillin.
  • The impacts would be especially high in low and middle-income countries.
  • In many African countries, in fact, India supplies almost 50 per cent of the medicines in value terms.

Lessons from the past: Policy initiative matters

  • Market share of foreign-owned multinationals in India was 80-90 per cent in 1970 in the pharmaceutical industry.
  • It fell to 50 per cent by the early 1980s, and down to 23 per cent today.
  • The prices of medicines in India fell from being amongst the highest in the world to amongst the lowest.
  • But this did not happen through sudden decoupling from foreign multinationals or a complete boycott or ban on imports.
  •  The 1970 Indian Patent Act removed product patent protection in pharmaceuticals.
  • So, the 1970 Patent Act is widely lauded for facilitating the growth of India’s industry.
  • India also benefited from the 1973 Foreign Exchange Regulation Act (FERA) and the subsequent New Drug Policy (1978).
  • Thus, a series of policy initiatives succeeded in tilting the balance in favour of Indian-owned firms.

But does it mean we have to depend on China forever?

  • No, but reducing dependence on China will not be easy to achieve.
  • In India, any decoupling from China must be strategic, with significant policy support.
  • It will take time for a paced indigenisation.

Government moves to reduce dependence for API

  • In March, the government announced Rs 3,000 crore to develop three bulk drug parks.
  • The government also announced Rs 6,940 crore to manufacturers of 53 bulk drugs over the next eight years.
  • Planning ahead towards greater domestic production of APIs, as well as reduced dependence on China, is an understandable and sensible policy objective.
  • Despite a decline in recent decades, India has a stronger starting point than most countries given the continued presence of some API production capabilities.
  • Indian firms have capacities, for instance, to produce COVID-19 treatments, including Remdesivir.

Consider the question “What are the APIs? Why India depends on other countries for it and what are implications of it? Suggest ways to reduce this dependence.”

Conclusion

In the short run, boycotts or bans would be counter-productive for the Indian industry, while also affecting access to much-needed medicines to India’s citizens and beyond. In the long run, however, reducing dependence on China would be strategically prudent.


Back2Basics: What are APIs?

  • Active pharmaceutical ingredient (API), is the term used to refer to the biologically active component of a drug product (e.g. tablet, capsule).
  • Drug products are usually composed of several components.
  • The API is the primary ingredient.
  • Other ingredients are commonly known as “excipients” and these substances are always required to be biologically safe, often making up a variable fraction of the drug product.
  • The procedure for optimizing and compositing this mixture of components used in the drug is known as “formulation.”

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

What are Biosimilars?

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Biosimilars

Mains level : Paper 3- What are the bio-similar molecules and their applications in the pharma sector?

Recently an Indian pharma company has been granted a USFDA approval for Insulin Glargine, a biosimilar. This article briefly introduces us to this term, complexities involved in its manufacturing and also explains why the USFDA approval create hype.

The story of simple molecules and some difficult diseases

  • Ever since modern medicine started to emerge post the Industrial Revolution, simple molecules have been used to treat most diseases.
  • While these formulations are highly effective against some illnesses, they aren’t particularly effective against more complex diseases like cancer.
  • Our immune system has evolved over millions of years to specifically defend against outside intruders.
  • But cancer isn’t like most diseases.
  • It’s not caused by an invasion of a foreign pathogen.
  • Instead, it’s a byproduct of rogue cells that destroy our bodies from within.
  • To this end, using simple molecules to defend against a barrage of mutating versions of our own cells is an exercise in futility.

What is biologic?

  • A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.
  • What we probably need is a biologic or a complex protein isolated from natural sources that can mimic our immune cells.
  • Maybe this would help us in fighting cancer.

So, Biosimilars are..

  • A biosimilar is a biological product that is developed to be similar to an already FDA-approved biologic, known as the reference product. It can be tempting to think of a biosimilar as a “generic” version of the reference product.
  • But biosimilar is not an exact duplicate of another biologic. There is a degree of natural variability in all biological products; it is not possible to generate a precise copy of a product that comes from living cells. All biologics—including reference products—show some batch-to-batch variation.

Utility of patents in the pharmaceutical industry

  • Success in this market is deeply intertwined with the research and development process that characterizes the pharmaceutical industry.
  • It might take 5 years for you to develop a new drug and you might still need another 10 years to clinically test the product and get the necessary approvals from the regulatory agencies.
  • This is a capital intensive process and the only way to remunerate the pharma company’s contribution is to protect their investment through patent laws.
  • This way the companies can be incentivised to invest more in research and we can ensure a steady supply of new drugs that could cure the greatest maladies of modern time.

What happens when the patent expires?

  • Once the patent expires, other companies can market their own version of the drug (copycats) if they can figure out how to synthesize it.
  • Consider — Aspirin. It’s a simple molecule drug and it’s quite easy to replicate the manufacturing process.

Why biologics would be difficult to replicate after the patent expires

  • Biologics are harvested from living cells and are often produced using complicated manufacturing processes.
  • Most modern biologics are assembled inside vats — or bioreactors — that house genetically engineered microbes or cell cultures and can often take a whole decade of research to perfect.
  • So replicating the process isn’t exactly a cakewalk.
  • Meaning if you want to market your own version of a “biologic” once all the patents expire, you need some expertise and India’s Biocon is at the forefront of this revolution.
  • For the past few years, they’ve been building a “biosimilar pipeline” — copycats of famous biologics and they’ve been using it to fight cancer, diabetes, and arthritis.
  • And it’s not all that easy for most pharma companies to enter this market.

Why marketing a drug in the US gather headline?

  • Because the US provides an opportunity like no other.
  • Buying drugs here is expensive and pharmaceutical companies make a killing in the process.
  • It might not necessarily bode well for consumers.
  • But it does provide a lucrative market for potential Indian manufacturers who are looking to sell their products elsewhere.

Consider the question “What is biosimilar technology? How is it different from generic medicine? Discuss its application.”

Conclusion

Growing expertise of Indian pharmaceutical companies in the complex research area bodes well for the Indian pharma sector which is known otherwise for the manufacturing of generic medicines.

 


Reference Source: https://finshots.in/archive/biocon-and-the-world-of-biosimilars/

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Fund for pharmaceutical innovators

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Drug patents

Mains level : Paper 3- Drug pricing issue

Pricing of the drugs in a contentious issue across the world. In some countries like the U.S. price of the drug at 100000%  of the production cost is not atypical. In India, prices are much lower. This article suggests the novel of Health Impact Fund which could strike the balance between affordability and R&D.

Medicines: Humanities greatest achievements

  • They have helped attain dramatic improvements in health and longevity as well as huge cost savings through reduced sick days and hospitalizations.
  • The global market for pharmaceuticals is currently worth ₹110 lakh crore annually, 1.7% of the gross world product (IPFPA 2017, 5).
  • Roughly 55% of this global pharmaceutical spending, ₹60 lakh crore, is for brand-name products, which are typically under patent.

Issue of high drug prices

  • Commercial pharmaceutical research and development (R&D) efforts are encouraged and rewarded through the earnings that innovators derive from sales of their branded products.
  • These earnings largely depend on the 20-year product patents they are entitled to obtain in WTO member states.
  • Such patents give them a temporary monopoly, enabling them to sell their new products without competition at a price far above manufacture and distribution costs, while still maintaining a substantial sales volume.
  • In the United States, thousandfold (100000%) markups over production costs are not atypical.
  • In India, the profit-maximising monopoly price of a new medicine is much lower, but similarly unaffordable for most citizens.

Covering large R&D costs: before we think about a solution

  • To be sure, before such huge markups can yield any profits, commercial pharmaceutical innovators must first cover their large R&D costs.
  • Currently, this cost is  ₹14 lakh crore a year (Mikulic 2020).
  • This includes the cost of clinical trials needed to demonstrate safety and efficacy, the cost of capital tied up during the long development process, and the cost of any research efforts that failed somewhere along the way.

Three concerns with R&D

1. Neglect of the diseases suffered by the poor

  • Innovators motivated by the prospect of large markups tend to neglect diseases suffered mainly by poor people, who cannot afford expensive medicines.
  • The 20 WHO-listed neglected tropical diseases together afflict over one billion people (WHO n.d.) but attract only 0.35% of the pharmaceutical industry’s R&D (IFPMA 2017, 15 and 21).
  • Merely 0.12% of this R&D spending is devoted to tuberculosis and malaria, which kill 1.7 million people each year.

2. High prices of new medicines

  • Thanks to a large number of affluent or well-insured patients, the profit-maximising price of a new medicine tends to be quite high.
  • Consequently, most people around the world cannot afford advanced medicines that are still under patent.
  • This is especially vexing because manufacturing costs are generally quite low.

3. Rewards are poorly correlated to the therapeutic value of drugs

  • Firms earn billions by developing duplicative drugs that add little to our pharmaceutical toolbox — and billions more by cleverly marketing their drugs for patients who won’t benefit.
  • These large R&D investments would be much better spent on developing new life-saving treatments for deadly diseases plaguing the world’s poor.

Health Impact Fund: Solution to the above problems

  • The Health Impact Fund as an alternative track on which pharmaceutical innovators may choose to be rewarded.
  • The basic idea behind it:
  • Any new medicine registered with the Health Impact Fund would have to be sold at or below the variable cost of manufacture and distribution.
  • But would earn ten annual reward payments based on the health gains achieved with it.

How health impact fund would work?

  • The Health Impact Fund could start with as little as ₹20000 crore per annum and might then attract some 10-12 medicines, with one entering and one exiting in a typical year.
  • Registered products would then earn some ₹17000-₹20000 crore, on average, during their first ten years.
  • Of course, some would earn more than others – by having greater therapeutic value or by benefiting more people.
  • Long-term funding for the Health Impact Fund might come from willing governments.
  • Those countries would contribute in proportion to their gross national incomes — or from an international tax, perhaps on greenhouse gas emissions or speculative financial transactions.
  • Non-contributing affluent countries would forgo the benefits: the pricing constraint on registered products would not apply to them.
  • This gives innovators more reason to register as they can still sell their product at high prices in some affluent countries and affluent countries reason to join.

The fund will have the following 5 major benefits

1. Help the Neglected areas of research

  • The Health Impact Fund would get pharmaceutical firms interested in certain R&D projects that are unprofitable under the current regime – especially ones expected to produce large health gains among mostly poor people.
  • With the Health Impact Fund in place, there can be more research on diseases like Tuberculosis or Malaria, even Covid.
  • We can develop rich arsenal of effective interventions and greater capacities for targeted responses quickly.

2. Rewarding health outcomes and not sales

  • The Health Impact Fund will focus on performance of drugs and not make it a marketing stunt.
  • Like in its model, firms would earn annual reward payments based on the health gains achieved with by the medicine.
  • Present scenario: firms seek to influence hospitals, insurers, doctors and patients to use their patented drug and to favour it over other more effective medicines.

3. Sustainable research and marketing system

  • A reward mechanism oriented towards health gains rather than high-markup sales would lead to a sustainable research-and-marketing system.
  • How? Simple for health gains, innovators will have to ensure:
  • They will have to think holistically about how their drug can work in the context of many other factors relevant to treatment outcomes.
  • They will need to think about therapies and diagnostics together, in order to identify and reach the patients who can benefit most.
  • They will need to monitor results in real time to recognize and address possible impediments to therapeutic success.
  • Finally, they will have need to ensure that patients have affordable access to the drug and are properly instructed and motivated to make optimal use of it with the drug still in prime condition.
  • Such a system would obviously make research more streamlined and sustainable.

4. No fear of compulsory licence clause

  • Participation of commercial pharmaceutical firms is crucial for tackling global pandemics.
  • At present such firms have issues with use of compulsory licences by governments as it divest them of their monopoly rewards.
  • Health Impact Fund registration would remove this risk as states would have no reason to interfere with innovators whose profit lies in giving real and rapid at-cost access to their new product to all who may need it.

5. Holistic approach

  • Multinational firms can collaborate with national health systems, international agencies and NGOs, to build a strong public-health strategy around its product.
  • The highest goal here would be complete eradication of many communicable diseases(Example: Malaria) which we are fighting right now.

Can we apply the above to Covid-19?

  • Applying it to a new disease like COVID-19 is complicated by the fact that we lack here a well-established baseline representing the harm the disease would have done in the absence of the new medicine to be assessed.
  • For malaria, such a baseline can be established on the basis of a stable disease trajectory observable over many years.
  • In the case of a new epidemic, one must rely on a modelling exercise that estimates the baseline trajectory on the basis of obtainable data about the spread of the disease and its impact on infected patients.
  • This surely is a challenging undertaking which cannot yield precise or uncontroversial results about what damage the epidemic would truly have done if the vaccine or medication in question had not appeared.

Consider the question “Drug pricing has always plagued the authorities and policymakers. Cap it and you tend to lose on innovation. Deregulate it, and high prices make it unaffordable. In light of this, examine the issues with the R&D in the pharmaceutical sector and suggest the ways to strike the balance between lives and innovation.”

 Conclusion

The Health Impact Fund would give innovators the right incentives. It would guide them to ask not: how can we develop an effective product and then achieve high sales at high markups? But rather: how can we develop an effective product and then deploy it so as to help reduce the overall disease burden as effectively as possible?

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Private: Pharmaceutical Sector in India – Opportunities and Challenges

India’s pharmaceutical sector is expected to be one of the very few industries that will record growth in this fiscal year amid strains from the COVID-19 pandemic and the Great Lockdown. Investors are looking at pharma companies as safer bets and the sudden surge in global demand for cheap and reliable drugs has presented a rare opportunity for the Indian pharmaceutical sector to transition from ‘Pharmacy of the World’ to ‘a Global Research Hub’. However, there are also issues in the way of India reaching this goal.

What is the current status of the Indian pharmaceutical sector?

  • India is considered as the ‘pharmacy of the world’ due to its ability to produce a wide range and great volume of medicines, that too at low costs.
  • Between 2000 and 2019, FDI of $16.2 billion was realized.
  • Currently, the sector is one of the top 5 sectors that are bringing down India’s trade deficit with other countries.
  • India is the largest producer of vaccines in the world – a title held by it even before the advent of COVID-19 and the demand stimulated by it. Its supplies meet more than 50% of the global demand for different vaccines
  • It is one of the leading producers of generic medicines.
  • A noted landmark in the growth history of the Indian pharmaceutical sector was when Cipla (an Indian firm) marketed anti-HIV medicines at 1/25th the market cost in sub-Saharan Africa.
  • 62% of the revenue contribution to this sector is from bio-pharmaceuticals.
  • More than 80% of the antiretrovirals used for treating AIDS around the world is supplied by India.
  • Of the Indian pharmaceutical sector, generic drugs constitute the largest segment with a market share of 70%.
  • OTC drugs constitute the next biggest segment with 21% of the market segment. Patented drugs account for 9% of the market share.
  • It has a presence even in countries like the USA, Japan, Australia and countries in Western Europe, which are noted for their stringent pharmaceutical standards.
  • Apart from this, India has been showing substantial progress in its ‘Ease of Doing Business’ ratings and the ‘Global Competitiveness Index’ rankings. This is an indication of the business environment improvement- and would attract more foreign players.

How is the sector regulated in India?

  • India has some of the toughest legislation in the world for drug regulation. It even provides for life imprisonment as a penalty for manufacturing spurious drugs.
  • According to the Drugs and Cosmetics Act, in case any sub-standard drugs are detected, the remaining stocks are to be recalled.
  • Under the provisions of the Drugs and Cosmetics Act of 1940, manufacturing, sale and distribution of drugs are regulated mainly by the state authorities under the states’ health departments.
  • Other aspects like licensing, approval, regulation of clinical trials and the quality assurance are handled by the Drugs Controller General of India at the central level.
  • The office of DCGI functions under the Central Drugs Standard Control Organisation (CDSCO). He/ she is advised by the Drug Technical Advisory Board and the Drug Consultative Committee.
  • The ultimate implementation and regulation of the drug manufacturers are carried out by drug inspectors, who are the foot-soldiers of the regulatory framework.

What are the government efforts for this sector?

  • FDI: The government has allowed 100% FDI in Greenfield pharmaceutical projects and 74% FDI in brownfield pharmaceutical projects. This move encourages investment for R&D work- especially for finding solutions for endemic health problems.
  • The government had launched the Pharma Vision 2020 with the following objectives:
  1. Transform India into a global leader in low-cost generics and end-to-end drug discovery and development.
  2. Make India one of the top 5 pharma innovation hubs in the world- this would entail India launching one out of every five new drugs globally.
  3. Meet the rising demand from the growing middle-class and quickly ageing population, which would exert significant pressure on the country’s healthcare system.
  • The government had launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana to supply low-cost pharma drugs to the economically weaker sections.
  • The government, in 2019, released draft rules for regulating the e-pharmaceutical companies. A regulatory platform is to be set up by the centre.
  • Drug intermediaries produced or imported into the country are to be tracked using QR codes according to a 2019 government initiative. This is soon to be made mandatory and will ensure quality and transparency in the sector.
  • In March this year, the Union Cabinet approved the establishment of mega ‘Bulk Drug Parks’ in association with state governments. These parks will have common facilities like solvent recovery, effluent treatment, distillation, etc.
  • The Cabinet also approved the ‘Production Linked Incentive Scheme’ for encouraging domestic manufacturing of drug intermediaries.

How is India making use of the opportunity presented by COVID-19 crisis?

  • India has been making use of ‘medical diplomacy’ to increase its influence in the international sphere.
  • Medical diplomacy is the state’s use of essential medicines’ trade and medical personnel’s dispatch to affected countries to improve its international relations.
  • India has been supplying essential drugs like hydroxychloroquine and paracetamol to different categories of countries ranging from USA, Russia, France and UK to African and Latin American countries like Zambia, Uganda, Niger, Kenya, Colombia and Uruguay.
  • In the neighbourhood, the drugs are being supplied to Afghanistan, Bangladesh, Bhutan, Nepal, Maldives, Mauritius, Myanmar and Sri Lanka.
  • While some of these countries received the drugs on a commercial basis, others received it as grants from India.
  • Apart from this, India is also dispatching its medicinal personnel to neighbours like Nepal.

What are the issues and challenges?

On the regulatory side:

  • Timely detection: The detection of spurious drugs often takes place much later than it is released into the market, which may be even months. Hence the CDSCO’s power to recall the drug stocks remains ineffective.
  • Insufficient capacity: A 2019 report highlighted the insufficient capacity and number of drug inspectors, lack of records on errant manufacturers, etc. The issue of uneven punishments for violators and incomplete enforcement of recalls were also highlighted.
  • Communication gap: The report also emphasised the communication gap between the drug regulatory bodies at the central and state levels.
  • Lax implementation: The lax implementation of regulations in India is evident from India’s handling of the NDMA (a carcinogen) contamination in ranitidine (a medication for treating heartburn).
  • While other countries’ regulators were recalling the product and studying its safety profile, the DCGI simply asked the drug manufacturers to ‘verify and take appropriate measures to ensure patient safety’.

 

On the quality side:

  • Assessment by Bureau of Pharma Public Sector Undertakings of India found that a significant portion of low-cost generics supplied under the PMBJP since 2018 was sub-standard. This led to batches being recalled.
  • Increased demands from the emergence of anti-microbial drug-resistant pathogens, changing lifestyles, demographics, the spread of non-communicable disease and other aspects have triggered several profit-driven firms to cut corners.

On the marketing side:

  • A significant slowing in the flow of prescriptions due to a drop in quality of medical representatives (MRs). The job is being done even by non-science graduates and undergraduates.
  • The pharma firms have been reducing the time and money spent on training MRs- in some cases, completely doing away with any training and directly putting the MRs on the field.
  • Compared to this, in countries like Russia, only medical graduates can be pharma sales representatives. In the EU, personnel are required to pass stringent examinations to qualify as MRs. They are also required to periodically renew their certification.
  • Pharma sales growth through the ‘Prescription Generation Model’ (mutual dependence between the doctors and the MRs for prescription generation) has been declining. Consequently, there has been an increase in return of expired stocks from stockists – sometimes as high as 4 to 5% (accepted level is 1%).
  • Use of freebies and gifts from the pharma firms to doctors to unethically promote the prescription of their drugs.

On capital and R&D aspects:

  • Indian pharmaceutical sector lags in the R&D aspect for developing new medicines- far behind other WTO countries. There has only been limited focus on research and innovation.
  • Developing novel drugs is a completely different game given its high capital and risk requirements. According to a 2016 assessment, it takes 2.87 billion USD to develop and get a drug approved.
  • The private capital is generally funnelled into SMEs- for expanding,  building larger factories, developing and registering generic drugs, acquisitions and product launches in different markets- not in producing novel pharmaceuticals.
  • R&D expense to GDP ratio of India is low- a mere 0.6%- compared to other countries. Eg: 2.1% in China. This is unfortunate as India has the required human capital and academic strengths to develop such novel drugs.

International aspects:

  • There is stiff competition from firms in countries like China, Israel and Japan.
  • Hostile and negative lobbying by the big players who frequently accuse Indian firms of violating patent laws.
  • Immediately following the 2005 implementation of the TRIPS agreement, the sector saw a surge in the number of patents grants. However, with the weakening of the Intellectual Property environment, there was significant waning.
  • Many countries have started working on policies to develop their own domestic pharmaceutical sector. This will reduce the demand for India’s generic drugs’ exports in the long run.
  • Warning letters about CGMP (Current Good Management Practices) violations from the US FDA to India has been historically high. In 2019, 34% of the FDA warnings were issued to Indian firms. In 2015, India firms had 50% share in such FDA warnings.

The API issue:

  • API or Active Pharmaceutical Ingredient is the raw material used for the production of pharmaceutical drugs. These are the components of the drug that are responsible for the actual curative/ therapeutic function.
  • China is one of the major producers of the APIs- especially in Hubei (of which Wuhan is the capital), Zhejiang and Jiangsu (neighbouring regions). The API production took a hit due to the COVID-19 outbreak and the subsequent lockdown in China.
  • This came to affect a significant part of world’s API supply.
  • India, for its part, depends heavily (nearly 90%) on Chinese-manufactured API. Indian firms like Granules India and AurobindoPharma are heavily dependent on Chinese raw materials for manufacturing antibiotics and antiretrovirals.
  • Concerns have been raised about the depleting API inventories in India.
  • This foreign-dependence and declining supply of API is expected to affect India’s ability to supply cheap drugs to the world.

way forward

  • The CDSCO must be empowered to conduct surprise inspections of manufacturing plants. The plants can be graded accordingly to help consumers understand the differences in the quality of the drugs.
  • In 2018, the creation of intelligence cells at the state level was recommended for detecting cases of sub-standard drug manufacturing. A dedicated post of Assistant Drug Controller for implementing recalls was also proposed.
  • It is vital to manage a comprehensive database on cases of non-compliance. This will enable better prosecution of offenders and risk-based deployment of the scarce personnel.
  • Reduce the chances for counterfeit drug production by getting top brands to use an anti-counterfeiting solution. Eg: uniquely coded products that can be verified using mobile phones.
  • Need for a revised ethics code to punish the use of gifts to promote pharmaceuticals.
  • There is a need for reforming and revamping the MR qualification processes.
  • Fortification of the MR model with new technologies like apps and devices.
  • Basic educational qualification for working as medical sales representatives must be made mandatory.
  • Establishing quality pharma schools is essential for a well-trained human resource in the field.
  • Though the Indian pharmaceutical sector has been moving ahead mostly using its generics segment, this isn’t reliable in the long term given the increasing tendency of many countries to develop their own pharmaceutical sectors for the same. A sure-fire way of maintaining pharmaceutical market presence is focusing on novel drug development.
  • Apart from high calibre academic institutions, there is a need for promoting R&D work and even more essentially, capital funding for developing these drugs.
  • Use of emerging technologies to aid in drug synthesis. Eg: in 2018, scientists in the UK have developed a ‘Chemputer’ program to ‘democratize the pharma industry’.
  • One possible route in developing these new drugs, the R&D work can be prioritised towards developing solutions for country-specific diseases.
  • Developing clarity on India’s patent laws and their enforcement will secure the sector’s viability. It will also promote innovation.
  • The policies governing IP rights must also be well-framed and rational.
  • In line with India’s Self-Reliance Mission, there is a pressing need to develop self-reliance in API production. India has far more FDA-approved API production centres than anywhere else in the world. This reflects the unexplored potential presented by the API segment. SMEs could be incentivized to manufacture API domestically under various initiatives like Make in India and StartUp India.
  • The time is especially ripe for attracting more FDI into India given the prevalence of anti-China sentiments in the global market. Developing the API production capabilities is low-hanging fruit for developing the Indian pharma sector. The works towards this goal can start with identifying API ingredients that are most in demand for production in India.
  • Over the last few years, the government has been improving the health infrastructure and healthcare accessibility via various schemes like Ayushman Bharat and Janaushadhi Pariyojana. This presents a vast potential to the pharma sector for expansion and reaching deep into the domestic market. It simply has to ensure quality and affordability.

Conclusion

The pharmaceutical sector is a lucrative but high risk and capital-intensive sector. India has made use of its human capital and knowledge base to catch the generic drugs’ wave. However, for the sector to stay afloat, it must diversify into more valuable products like novel drugs instead of only copying off-patent drugs. Developing a new drug and getting it approved for a market introduction may take decades. The current disruptive situation has presented another opportunity for addressing the various issues dragging the sector down. The question is how effectively and how quickly it is made use of.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Price Monitoring and Resource Unit (PMRU)

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Price Monitoring and Research Unit (PMRU)

Mains level : Drug prices monotoring mechanisms in India

The National Pharmaceutical Pricing Authority (NPPA) has set up price monitoring and resource unit (PMRU) in the UT of Jammu and Kashmir. With this J&K has become the 12th State/UT where the PMRU has been set up.

Price Monitoring and Research Unit (PMRU)

  • It is a registered society set up for drug price monitoring.
  • PMRUs have already been set up by the drug price regulator NPPA in 11 states such as Kerala, Odisha, Gujarat, Rajasthan, Punjab, Haryana, Nagaland, Tripura, Uttar Pradesh, Andhra Pradesh and Mizoram.

Its composition

  • The State Health Secretary would be the Chairman of the society and the Drugs Controller would be its member secretary.
  • Its members include a State government representative, representatives of private pharmaceutical companies, and those from consumer rights protection fora.
  • The society would also have an executive committee headed by the Drugs Controller.

Terms of reference

PMRU offers technical help to the State Drug Controllers and the NPPA to:

  • Monitor notified prices of medicines
  • Detect violation of the provisions of the DPCO
  • Look at price compliance
  • Collect test samples of medicines, and
  • Collect and compile market-based data of scheduled as well as non-scheduled formulations.

Why need PMRU?

  • Pharma companies have been accused of overcharging prices of drugs in the scheduled category fixed by the DPCO and those outside its ambit too.
  • The suggestion to set up PMRUs was made against the backdrop of the lack of a field-level link between the NPPA and the State Drugs Controllers and State Drug Inspectors to monitor drug prices.

Expected outcomes

  • The NPPA had fixed the prices of around 1,000 drugs and the unit would track if buyers were being overcharged.
  • It would also check if pharma companies were hiking the prices of non-scheduled drugs by more than 10% a year.
  • It will check if there is any shortage of essential medicines.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

What is an ‘Essential Commodity’?

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Essential commodities

Mains level : Regulation of essential commodities

Following reports of shortage and irrational pricing of hand sanitisers and masks, the union government has declared these items “essential commodities” until the end of June. It has notified an Order under the Essential Commodities Act to declare these items as Essential Commodities up to 30th June, 2020 by amending the Schedule of the Essential Commodities Act, 1955.

Why such move?

  • The coronavirus pandemic has triggered panic buying of masks and hand sanitisers at many places around the world, including in India.
  • The government’s order has come in the wake of reports of a shortage of these commodities and a sudden and sharp spike in their prices, and the alleged hoarding of stocks by manufacturers.

What does the government’s declaration mean?

  • The Essential Commodities Act provides, “in the interest of the general public, for the control of the production, supply and distribution of, and trade and commerce, in certain commodities”.
  • The law was passed in 1955 to essentially protect consumers from unreasonable and exploitative increases in prices of commodities in times of shortage.
  • It has been amended several times over the years, and made more stringent.
  • Under the Act, the government can also fix the maximum retail price (MRP) of any packaged product that it declares an “essential commodity”.

What kinds of items or products are generally classified as essential commodities?

  • The government has sweeping powers in this regard. The Act defines an “essential commodity” as simply “a commodity specified in the Schedule”.
  • The Act empowers the central government to add new commodities to the list of Essential Commodities as and when the need arises, and to remove them from the list once the crisis is over or the situation improves.
  • Over the years, a long list of items has been designated as essential commodities, including various drugs, fertilisers, cereals, pulses, sugar, edible oils, petroleum and petroleum products, and certain crops.
  • In the present situation, the government can intervene to regulate the supply and pricing of masks and hand sanitisers, and also notify their stock-holding limits.

How do states and UTs implement these orders?

  • They act on the notification issued by the Centre and implement the regulations.
  • Anybody trading or dealing in the essential commodity, including wholesalers, retailers, manufacturers, and importers, is barred from stocking it beyond the specified quantity.

What if the retailers/traders/manufacturers do not comply?

  • The purpose of designating any commodity as “essential” is to prevent profiteering at a time of extraordinary demand.
  • Violators are, therefore, termed as illegal hoarders or black-marketeers who can be prosecuted.
  • Besides penalties, the violation may lead to imprisonment for a maximum period of seven years.
  • Agencies of state governments and UT administrations are empowered to conduct raids to catch violators.
  • The government can confiscate excess stock hoarded by retailers/traders/manufacturers, and either auction it or sell it through fair-price shops.

Impact on Corona curbing

  • It is important to note that the designation of masks and hand sanitisers as “essential commodities” does not mean that the government considers them to be ‘essential’, in the literal sense, in the fight against COVID-19.
  • Doctors and health experts have underlined that the use of masks is helpful only if you have symptoms yourself, or if you are caring for someone who has symptoms.
  • The infection is spreading mostly through infected surfaces — and masks, especially the cheap surgical ones, can’t actually block the virus out.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[pib] Amendment to the Export Policy of APIs and formulations made from these APIs

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Active Pharmaceutical Ingredients

Mains level : Regulations of API

The Government has made amendments in the export policy and restricted export of specified APIs (Active Pharmaceutical Ingredients) and formulations made from these APIs.

Active Pharmaceutical Ingredients (APIs)

  • All drugs are made up of two core components: the API, which is the central ingredient, and the excipients, the substances other than the drug that helps deliver the medication to your system.
  • The API is the part of any drug that produces its effects.
  • Excipients are chemically inactive substances, such as lactose or mineral oil.
  • The quality of APIs has a significant effect on the efficacy and safety of medications.

The notification covers the following APIs and formulations made from these APIs:

  • Paracetamol
  • Tinidazole
  • Metronidazole
  • Acyclovir
  • Vitamin B1
  • Vitamin B6
  • Vitamin B12
  • Progesterone
  • Chloramphenicol
  • Erythromycin Salts
  • Neomycin
  • Clindamycin Salts
  • Ornidazole

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Medical Devices (Amendment) Rules, 2020

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Medical Devices (Amendment) Rules, 2020

Mains level : Regulation of medical devices in India

The Ministry of Health and Family Welfare has notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.

Medical Devices (Amendment) Rules, 2020

  • These rules are applicable to devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals” (as notified by the ministry).
  • It requires online registration of these devices “with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose.
  • Among the information that the manufacturer has to upload are “name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site.
  • It also need to upload certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.
  • This would mean that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in the country.
  • After furnishing of the above information a registration number will be generated. Manufacturer shall mention the registration number on the label of the medical device.

What are the items covered under the new Rules?

  • A large number of commonly used items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc are covered under the new rules.
  • For some items such as sphygmomanometers (used to monitor blood pressure), glucometers (to check blood sugar), thermometers, CT scan and MRI equipment, dialysis and X-ray machines, implants etc, different deadlines for compliance have been set.
  • For example for the first three, it is January 2021, for the others it is April next year. For ultrasound equipment, it is November 2020.

Is this a sudden move?

  • This has been in the offing for some time now.
  • In October last year, the ministry had circulated copies of the then proposed notification for public comments following recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest technical body for these decisions and has experts among its members.
  • In April last year, the DTAB had recommended that all medical devices should be notified as “drugs” under the drug regulation law to ensure they maintain safety and quality standards.
  • The notification makes it clear that the government has issued it in consultation with the DTAB.

Why was the move required?

  • For much of the last one year, the health sector has been at the centre of attention following revelations about faulty hip implants marketed by pharma major Johnson & Johnson.
  • This has caused major embarrassment to the government, too, as it exposed the lack of regulatory teeth when it came to medical devices.
  • The matter dragged on, exposing the regulatory loopholes until finally the company agreed in court to pay Rs 25 lakh each to the 67 people who had had to undergo revision surgeries because the implants were defective.
  • That is really where the discussion started about regulation of medical devices.

What are the penal provisions under Indian law?

  • There are various penal provisions under the Drugs and Cosmetics Act, 1940 for various kinds of offences. Manufacture or sale of substandard items is punishable with imprisonment of at least 10 years, which may extend to imprisonment for life.
  • There is also a provision for fine that will “not be less than Rs 10 lakh rupees or three times value of the confiscated items”.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

WHO prequalifies Serum’s low-cost Pneumococcal Vaccine

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Pneumococcal Vaccine

Mains level : Not Much

Pneumococcal vaccine developed by the Pune-based Serum Institute of India has been pre-qualified by the World Health Organisation (WHO).

Pneumococcal Vaccine

  • Pneumococcal vaccination is a method of preventing a specific type of lung infection (pneumonia) that is caused by the pneumococcus (Streptococcus pneumonia) bacterium.
  • There are more than 80 different types of pneumococcus bacteria – 23 of them covered by the vaccine.
  • The vaccine is injected into the body to stimulate the normal immune system to produce antibodies that are directed against pneumococcus bacteria.
  • This method of stimulating the normal immune system to be directed against a specific microbe is called immunization.
  • It does not protect against pneumonia caused by microbes other than pneumococcus bacteria, nor does it protect against pneumococcal bacterial strains not included in the vaccine.

About the Vaccine

  • The pneumococcal vaccine PNEUMOSIL is a conjugate vaccine to help produce stronger immune response to a weak antigen.
  • Serum Institute had optimized an efficient conjugate vaccine manufacturing processes for its meningitis A vaccine (MenAfriVac).
  • It was used for manufacturing the pneumococcal vaccine. This helped the company reduce the manufacturing cost of pneumococcal vaccine.

Why?

  • It pneumonia caused 1,27,000 deaths in India in 2018, the second highest number of child mortality under the age of five in the world.
  • In India, pneumonia and diarrhoea cause the most deaths in children under five years.
  • In 2017, pneumococcal conjugate vaccine was included in the under India’s Universal Immunisation Programme (UIP).
  • It has been introduced in a phased manner starting with Himachal Pradesh, parts of Bihar, Uttar Pradesh, Madhya Pradesh and Rajasthan.
  • The efficacy of the Serum vaccine was tested against an already approved pneumococcal vaccine (Synflorix).

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Indian Pharmacopoeia (IP)

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Indian Pharmacopoeia (IP)

Mains level : Not Much

The Indian Pharmacopoeia (IP) has been recognised officially by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Republic of Afghanistan.

Significance of the move

  • With this, a new beginning has been made and Afghanistan has become the first country to recognize IP pursuant to the efforts of Department of Commerce and Ministry of Health and Family Welfare.

Indian Pharmacopoeia (IP)

  • The quality, efficacy and safety of the medicines are important from healthcare perspective.
  • In order to ensure the quality of medicinal products, the legal and scientific standards are provided by Indian Pharmacopoeia Commission (IPC) in the form of Indian Pharmacopoeia (IP).
  • IP is an officially recognized book of standards as per the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder.
  • As per, the Second Schedule of the Drugs and Cosmetics Act, IP is designated as the official book of standards for drugs imported and/or manufactured for sale, stock or exhibition for sale or distribution in India.
  • Standards prescribed in the IP are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India.

What is IP Commission?

  • The IP Commission’s mission is to promote public and animal health in India by bringing out authoritative and officially accepted standards for quality of drugs.
  • It includes active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.
  • This is achieved by developing the standards for medicines and supporting their implementation.
  • In addition, IPC also develops IP Reference Substances (IPRS) that act as fingerprint for identification of an article under test and its purity as prescribed in the IP monographs.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] A band-aid

Note4Students

From UPSC perspective, the following things are important :

Prelims level : API

Mains level : Price regulation in India

Context

India’s drug regulator, the National Pharmaceutical Pricing Authority (NPPA), used the public interest provision of the Drugs Prices Control Order 2013 to allow manufacturers to increase prices of 21 essential drugs by as much as 50%. 

Price Rise

  • Critical diseases – Most of these drugs are used to treat critical diseases such as tuberculosis, malaria, and leprosy and are crucial to the country’s public health program. 
  • Usually reduces – the regulatory authority is usually known to slash prices of life-saving drugs. This decision is compelled by an extraordinary situation. 
  • Costs of production – For nearly two years, drug manufacturers are claiming an inability to keep up with the country’s healthcare demands due to increasing costs of production. 
  • Immediate crisis – Easing the price ceiling could help the healthcare system. It may preempt a situation where the public is forced to switch to costlier alternatives. 

Root cause

  • The drug regulator and the Department of Pharmaceuticals need to do much more to address the root cause of the shortage of critical drugs.
  • Imports – India’s pharma industry imports more than 60% of active pharmaceutical ingredients (APIs) or bulk drugs from China. 
  • Chinese regulators – In 2017, Chinese regulators cracked down on bulk drug manufacturing units as per the country’s environmental regulations. The Chinese API industry has raised prices. This has spin-off effects in India. 
  • Example of price rise – the cost of making Vitamin C pills has gone up by more than 250% since 2017. This has led to a 25-30% shortage of this drug in India. 
  • Leprosy drug – Pharma major, Abbot, applied to the NPPA to discontinue the production of the leprosy drug, Hansepran. It pointed out that increasing costs of API imports had made the production of Hansepran unviable in India.

Price control

  • Essential control – Making medicines more accessible to those who need them is essential. 
  • Failure – Drug price control measures in India have not always achieved this objective. 
  • Past – The ceiling on prices of 74 bulk drugs in 1995 forced many companies to opt-out of API production. 

Draft Pharmaceutical Policy 2017 

  • Indigenous API – Giving preference to drugs produced from indigenously produced APIs in government procurement and taking them out of price control for five years.
  • R&D – More importantly, the draft talked about creating research and development facilities for API production. 
  • It needs to be revisited in light of the country’s current medicine shortage.

Back2Basics

Active Pharmaceutical Ingredients(APIs)

These are the ingredients that give medicine its therapeutic value.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Nano-pharmaceuticals

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Nano-pharmaceuticals

Mains level : Nano-pharmaceuticals and their applications

  • The Ministry of Health and Family Welfare released guidelines for evaluation of nano-pharmaceuticals, which are emerging as more potent tools for treating various diseases.

What are Nano-pharmaceuticals?

  • Nanopharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the nanoscale.
  • They are derived by application of nanotechnology in medical therapeutics.
  • In the pharmaceutical industry, a long-standing issue is a difficulty of delivering the appropriate dose of a particular active agent to specific disease site.
  • Nanopharmaceuticals have enormous potential in addressing this failure of traditional therapeutics which offers site-specific targeting of active agents.
  • Such precision targeting via nanopharmaceuticals reduces toxic systemic side effects, resulting in better patient compliance.

Benefits

  • They are expected to bring about a revolution in treatment strategies as they would enable targeting specific delivery of drugs and therapeutic molecules.
  • They offer higher efficacy and lower toxicity in many disease conditions.
  • They are expected to be of great use particularly in cancer treatment.

Why need guidelines?

  • Every year several new nano-pharmaceuticals are being developed and marketed across the world.
  • India too has a sizable pool of nano-scientists generating a large number of scientific publications in this domain.
  • However, regulatory approval is the most important factor for translating laboratory research into bedside medicine.
  • The new set of guidelines is designed to facilitate this process.

About the guidelines

  • The guidelines cover all the aspects of evaluation from the definition and categorization of nano-pharmaceuticals to pharmacovigilance of the new set of therapeutics.
  • It has been prepared as a joint project by the Department of Biotechnology (DBT) in the Union Ministry of Science and Technology, and ICMR and Central Drugs Standard Control Organisation under health Ministry.
  • It will give a big boost to innovators and drug manufacturers to optimise their research and come out with medicines that would be safer and more affordable.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Ranitidine

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Ranitidine

Mains level : Hazards of Ranitidine


  • India’s drug regulator this week began looking into concerns of potential cancer-causing substances contaminating popular acidity drug ranitidine.
  • The move came over a week after the US flagged the issue to American patients, some companies have suspended sales of the product worldwide, and some have ordered recalls of the product.

Ranitidine

  • Ranitidine is an over-the-counter prescription antacid used in the treatment of acid reflux and peptic ulcer diseases.
  • It is popularly known through brand names like Aciloc, Zinetac, Rantac and Rantac-OD, R-Loc and Ranitin.
  • It is commonly used to relieve acid-related indigestion and heartburn by decreasing stomach acid production.
  • While other medicines like pantoprazole and omeprazole (omez) too treat these symptoms and are more commonly prescribed today, ranitidine is still widely used in India.

Why in news?

  • Ranitidine is a much older medication, but it was always thought to be a very safe drug because it has less side effects than the other drugs that patients use nowadays to treat these symptoms.
  • The US FDA stated in a release that it had learned that some ranitidine medicines contained “low levels” of a substance called N-nitrosodimethylamine (NDMA).
  • An environmental contaminant found in water and foods, NDMA has been classified as probably carcinogenic to humans, which means it has the potential to cause cancer.
  • This is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

How has India responded?

  • The Drugs Controller General of India (DCGI) wrote to state regulators asking them to direct ranitidine active pharmaceutical ingredient (API) manufacturers to verify their products and take appropriate measures to ensure patient safety.
  • DCGI asked states to inform him of action taken in this matter “at the earliest”.
  • So far, the DCGI has not called for any halting of supplies, which means the ranitidine brands marketed in the country can continue to be sold until further notice.
  • APIs are the ingredients that give a medicine its therapaeutic effect.
  • According to industry sources, most of the world’s supply of the ranitidine API comes from two Indian firms — Saraca Laboratories and SMS Lifesciences.

Should consumers be worried?

  • The DCGI has not clarified whether doctors and consumers in India should use ranitidine with caution, nor has the US FDA called for individuals to stop taking the drug at this time.
  • Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.

How have other countries responded?

  • While India and the US are still looking into the issue, regulators of around 15 countries are learnt to have called for recalls of ranitidine sold in their markets.
  • These include Singapore, Canada, Italy, Denmark, Finland, Norway, Switzerland and Pakistan.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Prohibition of E-cigarettes Ordinance 2019

Note4Students

From UPSC perspective, the following things are important :

Prelims level : ENDS

Mains level : Hazards of ENDS

  • The Prohibition of E-cigarettes Ordinance 2019 is being sent to a Group of Ministers as directed by the Prime Minister’s Office.

What are e-cigarettes?

  • An e-cigarette, short for electronic cigarette, is a battery-operated device.
  • One of a large variety of Electronic Nicotine Delivery Systems (ENDS), an e-cigarette emits vaporized nicotine, or non-nicotine solutions.
  • The user inhales it looking for a sensation similar to inhaling tobacco smoke, but without the smoke.
  • The pros and cons of e-cigarettes are hotly debated, with the industry refuting scientific evidence about the product being harmful, and users urging the government to legalize it.
  • India’s market for e-cigarettes, while nascent today, is projected to grow annually at more than 25 per cent in the next five years.

The draft ordinance

  • The draft ordinance was necessitated by the fact that an earlier order by the Centre asking the states to crack down against e-cigarettes could not stand judicial scrutiny.
  • However, a recent order, in which the High Court threw out a petition asking for protection from an ordinance against e-cigarettes, has emboldened the Health Ministry.
  • It now seeks legal backing for a ban (rather than just an advisory) in the form of an ordinance.
  • The ordinance makes any violation of its provisions punishable by imprisonment of one to three years, and a fine of Rs 1-5 lakh.
  • Some states have already banned use and sale of e-cigarettes, vape and e-hookah.

Why ordinance?

  • Under the Constitution, health is a state subject, so any move to ban manufacture and sale of a product on health grounds needs to come from the state government.
  • In February, the Central Drugs Standards Control Organisation had written to all state drug controllers, saying they should not allow sale, online sale, manufacture, distribution, trade, import or advertisement of ENDS.
  • The Delhi HC stayed the Centre’s circular banning sale and manufacture of ENDS like e-cigarettes and e-hookah with nicotine flavour, saying as the products were not a “drug”.

The scientific position on ban

  • The use of ENDS or e-cigarettes adversely affects almost all the human body systems with impact across the life course, from the womb to tomb.
  • The cartridges used in ENDS or e-cigarettes are filled with liquid nicotine, flavouring agents and other chemicals.
  • A typical cartridge contains about as much nicotine as a pack of 20 regular cigarettes and can act as a potential source for nicotine addiction.
  • Studies on these nicotine solvents had shown a varied degree of release of potential carcinogens depending on the battery output voltage.
  • The liquid-vaporizing solutions also contain toxic chemicals and metals that have been demonstrated to be responsible for several adverse health effects, including cancers and diseases of the heart, lungs and brain.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[pib] Janaushadhi Sugam

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Janaushadhi Sugam and its features

Mains level : Ensuring quality and cheaper medicines


  • Union Ministry for Chemicals and Fertilizers launched a mobile application “Janaushadhi Sugam”.

Janaushadhi Sugam

  • It aims to enable people to search Janaushadhi generic medicines and the stores at the tip of their fingers.
  • The mobile application would have user-friendly options like- to locate nearby Janaushadhi Kendra, direction guidance for location of the Janaushadhi Kendra through Google Map, search Janaushadhi generic medicines etc.
  • It will help analyse product comparison of Generic vs Branded medicine in form of MRP & overall Savings.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Oxytocin and issues over its commercial use

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Oxytocin

Mains level : Issues with use of Oxytocin

  • The final decision on whether the government can block private pharmaceutical companies from manufacturing and selling vital pregnancy drug oxytocin in India handed to the Supreme Court.

Oxytocin

  • Oxytocin, also known as the ‘love hormone’, is a hormone secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding.
  • It is secreted by pitutary glands in human body.
  • However, it can also be chemically manufactured and is sold by pharma companies for use during childbirth.
  • It is administered either as an injection or a nasal solution.

Why is it vital?

  • Oxytocin is a uterine stimulant hormone, prescribed for the initiation of uterine contractions and induction of labour in women, as well as stimulation of contractions during labour.
  • Oxytocin helps promote the release of breast milk.
  • It is also used to help abort the foetus in cases of incomplete abortion or miscarriage, and to control bleeding after childbirth.
  • It is also used widely in the dairy industry, agriculture and horticulture to boost production.

What is the case?

  • The health ministry in April 2018 notified a ban on private firms from manufacturing and selling oxytocin.
  • It wanted to restrict the responsibility of supplying the drug to a Karnataka-based public sector manufacturer to avoid its misuse in the veterinary field.
  • Following a case by drug makers like some private players the Delhi High Court in December 18 quashed the ban on various grounds, including that it lacked scientific basis.
  • The government has appealed the decision at the Supreme Court, arguing that the Karnataka PSUhas built up the capacity to manufacture and supply the required quantity of the drug here.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

APIs of drugs to get track-and-trace codes

Note4Students

From UPSC perspective, the following things are important :

Prelims level : API

Mains level : Regulating pharma sector

  • The Health Ministry may soon make it mandatory for companies to include codes to track-and-trace key ingredients used to make medicines in India
  • If implemented, the move will potentially be the first step by the government to pinpoint the origin and movement of drugs manufactured here and ensures their authenticity.

QR code for drugs tracking

  • A draft amendment mandating quick response (QR) codes at “each” level of packaging of active pharmaceutical ingredients (APIs), used to give medicines their therapeutic effect is ready and will be notified soon.
  • An API is the basic drug/ingredient in a pharmaceutical drug or pesticide that is biologically active.
  • For a medicine to be effective, the API has to be effective.
  • As a first step to tracking and tracing medicines in the country every API manufactured or imported in India will bear a QR code on its label at each level of packaging.
  • India is currently dependent on China for imports of APIs to make certain essential medicines.

Why such move?

  • The Active Pharmaceutical Ingredient is most important constituent of any drug formulation.
  • The supply chain with respect to its security and integrity in proper storage condition plays very important role to enhance quality supply of APIs.
  • API manufacturers should be held accountable and responsible for the quality and purity of their products.
  • APIs by “various” vendors have been found to be not as per defined specifications with respect to their quality, specifications and purity and in certain cases the desired effects are not obtained.
  • Often APIs are not manufactured at the right premises or such APIs are not manufactured with the required scientific techniques to produce the bio-active substance.

Curbing fake drugs

  • Drug regulators in India on many occasions flagged medicines produced by even large drug makers for failing quality tests.
  • There is lack of clarity on the scale of India’s counterfeit and substandard drug problem.
  • The US, in its Special 301 Report this year, estimated that up to 20 per cent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety.
  • However, a nationwide survey conducted by the Indian government between 2014 and 2016 concluded that only around 3 per cent of the medicines here were substandard and only 0.023 per cent spurious or counterfeit.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt. notifies new rules for drugs, clinical trials

Note4Students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Drugs and Clinical Trials Rules, 2019

Mains level:  Measures for ethical clinical trials of medicines in India


News

  • The Union Health Ministry has notified the Drugs and Clinical Trials Rules, 2019 aimed at promoting clinical research in the country.

Drugs and Clinical Trials Rules, 2019

  • The rules will apply to all new drugs, investigational new drugs for human use, clinical trials, bio-equivalence studies and ethics committees.
  • The rules has reduced time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  • Also, in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.
  • As per the new rule, the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries (EU, U.K., Australia, Japan and U.S.) specified by the Drugs Controller General with the approval of the government.
  • The new rules will ensure patient safety and an ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] The correct prescription

Note4Students

Mains Paper 2: Social Justice| Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: E-pharmacies

Mains level: The news-card analyses the issues of cartelisation in pharma sector and how e-pharmacies will increase the competition leading to better prices.


NEWS

CONTEXT

Amid a slew of conflicting judicial decisions from different High Courts, the legality of e-pharmacies continues to be questioned by various trade associations such as the All India Organisation of Chemists and Druggists (AIOCD).

E-pharmacies

  • E-pharmacies, which operate through websites or smartphone apps on the Internet, offer medicines for sale at a discount of at least 20% when compared to traditional pharmacists.
  • The added convenience of home delivery of medicines to one’s doorstep is there.
  • For scheduled drugs, patients can submit photographs of prescriptions while placing orders.
  • The legal status of these e-pharmacies is not clear because the government is yet to notify into law draft rules that it published in 2018.

Opposition to e-pharmacies

  • The fiercest opponents of e-pharmacies are trade associations of existing pharmacists and chemists.
  • They argue that their livelihoods are threatened by venture capital-backed e-pharmacies and that jobs of thousands are on the line.
  • These trade associations also spin imaginary tales of how e-pharmacies will open the door to drug abuse and also the sale of sub-standard or counterfeit drugs, thereby threatening public health.

Need for e-pharmacies to curb cartelisation

  •  The entry of e-pharmacies will have effect on lowering the price of medicine for Indian patients.
  • Associations of pharmacists is one of rampant, unabashed cartelisation that has resulted in an artificial inflation of medicine prices.
  • In a fully functional, competitive market, pharmacists would compete with each other for business.
  • This competition could happen in the form of discounts or improving operational efficiency.
  • This practice of two competitors colluding to fix the sale price and area of operation is called cartelisation and is illegal under India’s Competition Act.
  • Over the last decade, the Competition Commission of India (CCI) has had to deal with several complaints alleging that trade associations of pharmacists are providing platforms for cartelisation.

Barriers in way of e-pharmacies

  • The practice of requiring pharmaceutical companies to apply for a no-objection-certificate (NOC) from the regional trade association before they appoint new stockists in a region to sell a particular drug prohibits competition.
  • By creating such artificial, extra-legal barriers to the free trade of medicines within India, these trade associations create huge distortions in the Indian market.
  • In its recent policy note on “Making markets work for affordable healthcare”, published in October 2018, the CCI noted, “One major factor that contributes to high drug prices in India is the unreasonably high trade margins.”
  • One of the culprits for this phenomenon identified by the CCI was “self-regulation by trade associations [which] also contributes towards high margins as these trade associations control the entire drug distribution system in a manner that mutes competition”.

Solutions Proposed by CCI

  • As stated by the CCI in its policy note, “Electronic trading of medicines via online platforms, with appropriate regulatory safeguards, can bring in transparency and spur price competition among platforms and among retailers, as has been witnessed in other product segments.”

Way Forward

Where the state has failed, it is possible that venture capitalist backed e-pharmacists will succeed in bringing back competition to the retail drug markets in India. There is no reason for India to continue indulging trade associations that have no taste for competition or fair business practices.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

All Medical equipment notified as drugs

Note4Students

Mains Paper 2: Governance | Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level:  Not Much

Mains level:  Regulating medical and diagnostics devices & services


News

  • All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator have been notified as drugs with effect from April 1, 2020.
  • The Central Drugs Standard Control Organization (CDSCO) is the national medical device regulator for its sale and use.

Why such move?

  1. A majority of medical devices are unregulated in India.
  2. These eight medical equipments have been notified as ‘drugs’  under Section 3 of the Drugs and Cosmetics Act, 1940.
  3. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.
  4. This will regulate medical and diagnostics devices in the country.
  5. It will create a new regulatory marketing approval system and the government can keep a tab on importers as well as manufacturers.

Criticisms

 

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

At first, Kerala sets up drug price monitor

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From the UPSC perspective, the following things are important:

Prelims level: PMRU and its mandate

Mains level:  Need for an effective Pharma price monitoring agency


News

  • Kerala has become the first State to set up a price monitoring and research unit (PMRU) to track violation of prices of essential drugs and medical devices under the Drugs Price Control Order (DPCO).
  • The move comes more than five years after the National Pharmaceutical Pricing Authority (NPPA) proposed such a system for the States and the Union Territories.

Price Monitoring and Research Unit (PMRU)

  1. A society had been registered to get Central assistance for the functioning of the unit.
  2. The State Health Secretary would be the Chairman of the society and the Drugs Controller would be its member secretary.
  3. Its members include a State government representative, representatives of private pharmaceutical companies, and those from consumer rights protection fora.
  4. The society would also have an executive committee headed by the Drugs Controller.

Terms of reference

The new watchdog will offer technical help to the State Drug Controllers and the NPPA to:

  • Monitor notified prices of medicines
  • Detect violation of the provisions of the DPCO
  • Look at price compliance
  • Collect test samples of medicines, and
  • Collect and compile market-based data of scheduled as well as non-scheduled formulations.

Why such move?

  1. Pharma companies have been accused of overcharging prices of drugs in the scheduled category fixed by the DPCO and those outside its ambit too.
  2. The suggestion to set up PMRUs was made against the backdrop of the lack of a field-level link between the NPPA and the State Drugs Controllers and State Drug Inspectors to monitor drug prices.
  3. The unit is expected to help the State Drugs Control wing, which is hit by severe staff shortage, and regulate drug prices more effectively.
  4. There is also a plan to collect data on the prices of surgical devices and stents in the market.

Expected Outcomes

  1. The NPPA had fixed the prices of around 1,000 drugs and the unit would track if buyers were being overcharged.
  2. It would also check if pharma companies were hiking the prices of non-scheduled drugs by more than 10% a year.
  3. It will check if there is any shortage of essential medicines.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] Right prescription: the ban on retail sale and private manufacture of oxytocin

Note4students

Mains Paper 2: Governance | Government policies & interventions for development in various sectors & issues arising out of their design & implementation

From the UPSC perspective, the following things are important:

Prelims level: Oxytocin

Mains level: Flaws in the framing of health policies in India and the need of making the system better


Context

HC lifts the ban on the sale of oxytocin

  1. In a crucial development that exposes the flaws in health policy-making in the country, the Delhi High Court quashed a government ban on the retail sale and private manufacture of oxytocin
  2. Notified by the Union Ministry of Health and Family Welfare in April, the ban referred to a 2016 Himachal Pradesh High Court judgment, which discussed oxytocin’s misuse in dairy cattle, fruits and vegetables

Importance of Oxytocin

  1. Oxytocin is a life-saving drug used to stem post-partum bleeding among new mothers
  2. Because of this, it had been listed by both the World Health Organization and the Health Ministry as an essential medicine
  3. Around 45,000 women die from post-partum complications in India each year, and in 38% of the cases the reason is haemorrhaging
  4. Without the easy availability of inexpensive oxytocin, efforts to stem the maternal mortality epidemic could have suffered a costly setback

HC observations

  1. The court found that the government had failed to weigh the danger the ban posed to thousands of young mothers
  2. What is more, it had failed to show that the drug was widely misused for veterinary purposes, the purported reason behind the order
  3. The most damning observation in the judgment is that the Centre focussed on the health of milch animals, without considering the well-being of women
  4. This was despite the fact that all statutory bodies, including the Drugs Technical Advisory Board, had advised against a ban

Way forward

  1. It is time for a post-mortem of how health policy is made, because that is the only way to safeguard the right to health of Indian citizens

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt to set up National Medical Devices Promotion Council

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: NMDPC

Mains level: Functions of the proposed council


News

National Medical Devices Promotion Council (NMDPC)

  1. To give a boost to the medical devices industry, which is a sunrise sector, Union Govt will set up of a National Medical Devices Promotion Council.
  2. It will be an agency under the Department of Industrial Policy and Promotion (DIPP) in the Ministry of Commerce and Industry.
  3. The proposed national council, headed by the Secretary, DIPP, would achieve convergence as medical devices were covered under various Ministries and departments.
  4. Apart from the concerned departments, it will also have representatives from healthcare industry and quality control institutions.

Functions of the proposed NMDPC

  1. The NMDPC will undertake several activities including facilitation, promotion and development of the sector besides holding seminars and workshops to garner views of industry and understand best global practices.
  2. It would also identify redundant processes and render technical assistance to the agencies and departments concerned to simplify the approval processes involved in the sector.
  3. It will enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector.
  4. It support dissemination and documentation of international norms and standards for medical devices, by capturing the best global practices and facilitate domestic manufacturers to rise to international level.
  5. It will also drive a preferential market access policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in imports.
  6. Besides, it would make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector.

Why such move?

  1. The medical devices industry plays a critical role in the healthcare ecosystem and is indispensable to achieve the goal of health for all citizens.
  2. Although the industry has been growing in double digits, it is predominantly import-driven, with imports accounting for over 65 per cent of the domestic market.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[pib] Positive Impact of GST on Pharma Sector

Note4students

Mains Paper 3: Economy | Effects of liberalization on the economy, changes in industrial policy & their effects on industrial growth

From the UPSC perspective, the following things are important:

Prelims level: Not Much

Mains level: India’s pharma sector


News

Growth in Pharma Sector

  1. Turnover: Before GST, Annual Turnover as on 31.05.2017 was Rs 1,14,231 crores while after GST, the same as on 31.05.2018 touched Rs 1,31,312 crores, which is 6% higher than the Pre-GST regime.
  2. Exports: During 2016-17 Exports were Rs 2,75,852 crores while post-GST, in the year 2017-18, they were recorded at Rs 3,03,526 crores, which is 10% higher than the Pre-GST Regime.
  3. As per estimates, the export figure for the current year is likely to be Rs 3,27,700 crores, which will be almost 12% higher than the export figure of Pre-GST regime
  4. Drug Approvals: There has been a significant jump in number of Drug Approvals from 7,857 before GST to 10,446 post-GST.

How this all became possible?

  1. The GST regime removed the complexity of multiple taxes has reduced their cascading effect on the final product.
  2. GST is expected to decrease the manufacturing cost in view of merging of different taxes levied earlier and promote ease of doing business.
  3. Due to discontinuation of Central Sales Tax post-GST, it will reduce transaction costs, as inter-state transaction between two dealers will become tax neutral.
  4. Now, the pharma companies can consolidate their warehouses at strategic locations, effecting a reduction in cost of distribution.
  5. As a result, it will benefit warehouse strategy and improve supply chain efficiency in pharma sector.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt prohibits manufacture, supply, sale of 328 FDC drugs

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: FDCs

Mains level: Issues in Pharma Sector.


News

Ban on certain FDCs

  1. The government has prohibited the manufacture, sale or distribution of 328 fixed dose combination (FDC) drugs for human use with immediate effect.
  2. The health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, covering 6,000 brands.
  3. Certain painkillers, antibiotics, antiseptics for treatment of mouth and throat conditions and anti-diabetic drugs got a relief but with some restrictions.

What are FDC drugs?

  1. An FDC drug includes two or more active pharmaceutical ingredients combined in a single dosage form, which is manufactured and distributed in fixed doses.
  2. The major advantage of FDCs is improved medication compliance by reducing the pill burden of patients.
  3. However if an adverse drug reaction occurs it may be difficult to identify the active ingredient responsible for causing the reaction.

Irrational FDCs

  1. The expert panel probing the efficacy of 349 banned FDCs gave its report to India’s top drug advisory body, the Drug Technical Advisory Board (DTAB).
  2. The panel after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, recommended continuing the ban.
  3. It also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
  4. The Supreme Court has earlier suggested the DTAB to decide the fate of these drugs.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Health Ministry comes out with draft rules on sale of drugs by e-pharmacy

Note4students

Mains Paper 3: Science & Technology | Developments and their applications and effects in everyday life

From UPSC perspective, the following things are important:

Prelims level: Particulars of the Draft Policy

Mains level: E-Commerce of Pharmaceuticals in India


News

Context

  1. The Union Health Ministry has come out with “Draft Rules on “Sale of Drugs by e-pharmacy”” with an aim to regulate online sale of medicines across India
  2. This seeks to provide patients accessibility to genuine drugs from authentic online portals.
  3. These pharmacies will be purchasing directly from the drug manufacturer so they will also be able to give 20-30 per cent discounts, thus benefiting the patients.

Registration Mandatory for e-Pharmacy

  1. The draft states that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered.
  2. Any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government.
  3. The Central Drugs Standard Control Organization (CDSCO), the country’s apex drug regulator and central licensing authority is the nodal agency.
  4. The application will have to be accompanied by a sum of Rs 50,000 while asserting that an e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000).
  5. The supply of any drug shall be made against cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as record.
  6. The registration will remain valid for a period a three years from the date of its issuance and a renewal of registration will have to be done.

Patients Privacy to be Protected

The details of patient shall be kept confidential and shall not be disclosed to any person other than the central government or the state government concerned, as the case may be.

Certain Restrictions to be there

  1. Sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs have been prohibited through these portals.
  2. The premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorised by the Central Licensing Authority.
  3. It would binding on the e-pharmacies to deliver the drugs in the specific time that will be told to the patient during the time of purchase.
  4. The e-portals are mandatorily required to have 24/7 call centres.
  5. No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose if it contravenes any provision of the Drugs and Cosmetics Act, 1940.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] The need for growth in Indian biosimilars

Note4students

Mains Paper 3: Science & Technology | Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology

From UPSC perspective, the following things are important:

Prelims level: Biosimilars, Biologics

Mains level: The potential of generic drugs market in India & the world and how India can lead in its production


Context

India’s rise in the generic drugs market

  1. By responding strongly to a soaring demand for generic drugs, India’s pharmaceutical producers emerged as world market leaders in this sector and were a major business success story in the 2000s
  2. In the process, Indian producers made a valuable contribution to reducing costs and to expanding access to life-saving treatments for patients, both in emerging markets and in developed countries

Current trends in the pharma sector

  1. Globally and especially in developed countries there are waves of consolidation among pharma retailers
  2. There is stiffer competition from Chinese pharma manufacturers
  3. Along with these, an uptick in generic drug applications have combined to put downward pressure on drug prices

Emerging prospects in the pharma sector

  • There is a new push to produce more so-called complex generics
  1. These are hybrid medicines that often contain complex active pharmaceutical ingredients (the part of the drug that produces its effects) or formulations, or routes of delivery
  2. Indian firms have succeeded in capturing 19% of the global market in complex generics thus far
  • Pharma companies would be well-advised to pursue is to expand their footprint in the biosimilars market
  1. Biosimilars are the generic versions of biologics medicines made from animal or plant proteins as opposed to chemicals
  2. Biologics are important market disrupters because they are transforming how we treat diseases, including certain types of cancer, rheumatoid arthritis, and multiple sclerosis
  3. Biologics are notable for targeting the underlying causes of diseases as opposed to just the symptoms, with fewer side effects

Need for biosimilars 

  1. The growth in the biosimilars market is welcome from a human development standpoint because they are more affordable than biologics, the high cost of which often puts them out of reach of many patients
  2. Promoting the production of complex generics and biosimilars can have a positive development impact given how targeted they are toward treating non-communicable diseases such as cancer, asthma, and arthritis
  3. An alarming spike is being seen across developing countries in the prevalence of non-communicable diseases
  4. For example, diabetes is fast becoming an epidemic in developing countries, with rates rapidly catching up with those of the developed world

Way forward

  1. It is increasingly clear that the segment of the pharmaceutical market where the demand will grow the fastest in the coming years is products that treat non-communicable diseases
  2. The government should, therefore, strive to promote strong, indigenous producers of complex generics and biosimilars as this has enormous potential to improve public health in emerging markets

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

EU, India to collaborate on developing next generation influenza vaccine

Note4students

Mains Paper 3: Science & Technology | Developments and their applications and effects in everyday life

From UPSC perspective, the following things are important:

Prelims level: Horizon 2020

Mains level: Read the attached story.


News

Horizon 2020

  1. The EU and Department of Biotechnology will collaborate in research and innovation for developing a next generation influenza vaccine to protect people worldwide.
  2. The joint effort aims to develop cost-effective and affordable influenza vaccine rapidly without compromising quality.
  3. In total, 30 million Euros (shared by both members) has been earmarked for research and innovation actions which aim at advancing the efficacy, safety, duration of immunity, and reactivity against an increased breadth of influenza strains.
  4. The projects require minimum three applicants from Europe (three different EU member states) or countries associated to the EU programme Horizon 20202) and minimum three applicants from India.
  5. The projects are also ‘Open to the World’ and thus applicants from other countries can join the EU-India consortia.

Importance of the Mission

  1. This joint call is another demonstration of the increased cooperation between the EU and India as committed by the leaders during the Summit in October 2017.
  2. In engaging jointly on this topic, India and the EU are contributing to an important global public health challenge.
  3. Improved influenza vaccines would help the international community to better prepare in the event of an influenza pandemic.
  4. The outcome of the project is expected to contribute to the achievement of Sustainable Development Goal 3 to ensure health and well-being for all and boost the Indian National Health Mission.
  5. Seasonal flu vaccination is also high on the EU health agenda with the European Commission urging EU member states to commit to vaccinating 75 per cent of risk groups against seasonal flu each year.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] Cure that hurts

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Not much

Mains level: Clinical trials in India & the regulations related to it


Context

Hip replacement failure & denial of compensation

  1. An important expose has revealed that the Indian arm of Johnson and Johnson (J&J), a leading global pharma major, “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in the country using “faulty” hip replacement systems imported by the company
  2. The report also revealed that J&J did not provide compensation to all the affected patients
  3. An expert committee of the Union Ministry of Health and Family Welfare (MoHFW) had recommended that the pharma giant provide compensation to the patients who had undergone a surgery to implant the faulty device

Factors that interact to “manufacture” a public health catastrophe in India

  • First, there is a booming market for joint replacement in India
  1. A recent survey projects that the joint replacement market will grow at an annual rate of around 25 per cent to 30 per cent over the next five to seven years
  2. It would be naive to believe that such a market would remain untouched by multinationals like J&J
  • Second, it is critical to note that J&J in the US behaves much better than it does in India
  1. The company has settled more than 9,000 lawsuits over the defective hip model in question for around $4.4 billion between 2013 and 2015
  2. Since 2015, juries in the US have awarded $1.7 billion as compensation over the hip implants
  3. The regulatory deficit in the medical devices market in India leads to low standards of service by pharma companies
  4. The data suggests that technology assessment for medical devices and quality control methods in the country do not compare well with those in the Western world
  • Third, Poor regulation of clinical practices is a reason for errant medical giants going unpunished
  1. The pharmaceutical companies and medical device manufacturers sponsor foreign trips, national and international conferences and even vacations of physicians
  2. Doctors serve on the payrolls of medical device companies. They promote implants, including the faulty hip replacement device in question
  3. Surgeons or physicians are obliged to the companies that manufacture them
  4. The poor medical ethics of the Indian physicians serves the interests of big companies very well

Why this situation arose?

Two important events accelerated the country’s decent into a healthcare nightmare

  1. The uncontrolled opening up of Indian markets in the 1990s
  2. The country ratifying the World Trade Organisation (WTO), which led to it becoming fully compliant with Trade Related Intellectual Property Rights (TRIPS) in January 2005

Impact

  1. TRIPS compliance made it easy for pharma companies to carry out clinical trials in the country
  2. There was an influx of international companies who claimed to provide the state-of-the-art drugs, implants and technologies to doctors and patients, mostly in the garb of clinical trials
  3. The absence of rigorous regulations led to serious violations of patients’ rights
  4. It is believed that between 2005 and 2012, more than 2,000 patients have died across the country while participating in clinical trials conducted by pharma companies

Way Forward

  1. With a poor regulatory mechanism, a corrupt healthcare system and a greedy doctor at their doorstep, such companies and their businesses stand to thrive in the graveyard of India’s healthcare
  2. This is a breach of medical ethics and moral principles and J&J stands exposed as a classical example of corporate high handedness, emboldened by administrative flaws and poor procedures of accountability
  3. It is important to unravel this violation of patients’ rights because that will help us be vigilant against future malpractices by international pharma firms

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] Learning from the past on medical device pricing

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: NPPA

Mains level: Recent government decision to cap prices of various medical devices & how such move will affect the industry as well as patients


Context

Government plans to reduce prices of medical devices

  1. After having brought down the prices of drugs, the government has medical devices on its agenda
  2. It will soon announce its decision on the method of rationalizing trade margins for medical devices from the first point of sale

Why using first point of sale?

  1. According to the report of the committee of high trade margins in the sale of drugs, released by the department of pharmaceuticals in 2016, the price to the distributor for both global and indigenous companies was considered from the first point of sale
  2. This report clearly identifies that it is the margin between the price to the distributor and maximum retail price (MRP) that results in the escalation of the latter, and recommends that this should be capped

Failures of the past

  1. Till 2012, the practice followed by the NPPA was a maximum allowable post-marketing expense (Mape) over standardized manufacturing cost or over landing cost of the product
  2. According to the observations documented in National Pharmaceuticals Pricing Policy, 2012 (NPPP-2012), the manufacturing cost/landing cost methodology of price capping had led to “possible manipulation” of cost data, resulting in entry barriers
  3. The idea of price capping based on manufacturing cost/landing cost as per Drug Price Control Order 1995 was an unmitigated disaster
  4. The emphasis on price control starting at the bulk drug and formulation stages resulted in drug manufacturing shifting away from notified bulk drugs and formulations under price control

Medical device industry has higher expenses

  1. The scale of investment in pharmaceuticals is less than what it is for the medical device industry
  2. In medical devices industry spending needs to be done on skill development, in-clinic support, innovation and after-sales service of equipment

Why are price caps of medical devices a bad idea?

  1. If a patient feels a certain medication is not effective, he will go back to the doctor to change it, but this is not the case when it comes to medical devices
  2. The risk factor is high, as medical devices can’t be replaced without re-operating on patients
  3. Doctors need to be aware of the availability of various medical devices for different conditions before treating a patient so that they can guide patients and form an effective referral chain to super-speciality care
  4. For this, the global research-based companies need to invest and support clinicians in education and skill building

Ensuring success of Ayushman Bharat

  1. In this Union budget, the government focused on the healthcare sector, launching the world’s largest government-funded healthcare programme, Ayushman Bharat
  2. Besides providing health insurance to 100 million poor families, the government also plans to open 150,000 health and wellness centres to provide comprehensive healthcare with free diagnostics and treatment
  3. For the success of these initiatives, a lot of skill-building activities are required
  4. At this stage, if the rationalization of trade margin is not calculated from the first point of sale, companies will stop investing in these activities
  5. That would increase the chances of the scheme failing

Way Forward

  1. The department of pharmaceuticals’ recommendation on trade margin rationalization from the first point of sale is the most viable solution available
  2. It will not only allow global companies to sell innovative products but also enable them to invest in skill development along with therapy awareness, while still ensuring affordability by correcting the skewed margins in the supply chain

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] How WHO’s Essential Diagnostics List Can Spur Innovation, Quality Assurance

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: WHO EDL

Mains level: Diagnostic research in India & other low-income countries and its impacts on health as well as economy


Context

WHO’s initiative for essential drug listing

  1. Lack of access to diagnostic services, incorrect diagnosis and late diagnosis often leading to wrong treatment, serious health complications, higher health cost and risk of spread of infectious diseases has prompted World Health Organisation to come out with a significant first ever Essential Diagnostics List (EDL) on May 15 this year
  2. EDL, developed by 19 experts with global representation, aims to serve as a reference for countries to either develop or update their list of essential diagnostics
  3. The EDL is aimed at bringing some parity in a world where half the population does not have access to essential health care services, where the Sustainable Development Goals have the tall task of achieving universal health coverage by 2030

Concern areas in diagnostics

There are broadly three areas of concern in diagnostics – access, quality and implementation

  1. Access issues include lack of laboratories, personnel, distance to the laboratory, high cost, lack of appropriate diagnostic test etc
  2. Quality issues which hinder implementation of many diagnostic tools in LMIC include poor quality of tests, trying environmental conditions like extreme temperatures, high humidity and maintenance of equipment (instruments) among others
  • Lopsided research and development is another issue in diagnostics
  1. For example, research in diagnostics continues to languish way behind than that in drugs and vaccines
  2. Diagnostics development is targeted mainly at high-income countries and there is a dire need to boost R&D in diagnostics in countries like India

Positive externalities of diagnostics

A sound diagnostics regime has many positive externalities

  • Checking rampant antibiotic use, accreditation to ensure quality
  • Establishing a sound supply chain
  • Creating laboratory infrastructure
  • Ushering technological advancement
  • Making more and exorbitant tests affordable
  • Building necessary human resources
  • Addressing existing information asymmetry

How can EDL help?

  1. There are a few innovations in diagnostics such as portable laboratories, smartphone-enabled microscopes, AI-led breast cancer screening tool which have shown promise in low cost, easy access diagnostics
  2. The EDL can now help channel such innovations to diagnostics
  3. Low and middle-income countries (LMIC), facing the double burden of communicable and non-communicable disease which limits their economic and human development could find EDL handy in moving away from the largely prevalent syndromic treatment by ushering innovation and better quality control practices

Way Forward

  1. It is in India’s interest to align itself with the WHO EDL to create the necessary innovative ecosystem and build capacity to fill the numerous gaps that currently exist in the country’s diagnostics

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] Questioning a crackdown

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Oxytocin, Drugs Technical Advisory Board (DTAB), Drugs Consultative Committee (DCC), Drugs & Cosmetics Act, 1940,  Indian Council of Medical Research, National Dairy Research Institute

Mains level: Laws regulating pharma sector in India & their occasional usage in an adverse way leading to more problems than solutions


Context

Recent ban on Oxytocin

  1. The decision of the Ministry of Health to restrict, from September 1, the manufacture of oxytocin only to the public sector unit, Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL), has sparked fears of shortages and a disruption of supplies of this drug
  2. The restriction is because of alleged misuse of the drug by dairy farmers on milch cattle to stimulate milk production
  3. The Ministry now hopes to control distribution channels and prevent misuse

About Oxytocin

  1. Oxytocin is a hormone that acts on organs in the body (including the breast and uterus) and as a chemical messenger in the brain, controlling key aspects of the reproductive system, including childbirth and lactation, and aspects of human behaviour
  2. Oxytocin is important during childbirth and breastfeeding
  3. Oxytocin is a neurotransmitter and a hormone that is produced in the hypothalamus
  4. From there, it is transported to and secreted by the pituitary gland, at the base of the brain

Is oxytocin really harmful?

  1. Minutes of the meetings of the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) — (statutory bodies under the Drugs & Cosmetics Act, 1940 cite experts from the medical and veterinary sciences who advised the DTAB that oxytocin is required in the treatment of both humans and animals
  2. Two studies by the Central government, by the Indian Council of Medical Research and the National Dairy Research Institute, conclude that the use of oxytocin does not have an adverse effect on either people or animals
  3. With cattle, the danger of misuse is that it may cause addiction, in which case cattle do not react to normal milk ejection stimuli

Why was production restricted to public sector company?

  1. It is due to a judgment by the High Court of Himachal Pradesh in a public interest litigation (PIL) initiated by the court after it came across newspaper reports of oxytocin misuse
  2. The court passed a judgment in 2016 blaming oxytocin for a number of diseases, including breast and uterine cancers, male impotence, excessive hair growth in women and balding for men
  3. However, the court did not cite a single scientific study to support these claims
  4. Towards the end of its judgment, the court directed the State government to consider the feasibility of restricting manufacture to the public sector
  5. The Central government decided to adopt the judgment as the basis of its order restricting manufacture to the public sector
  6. The fact is that the High Court sought a study of the feasibility of restricting manufacture to the public sector; it never ordered the restriction to be imposed

What should be the basis of the ban?

  1. A study of the degree of misuse
  2. The demand for the drug
  3. The manner in which the proposed restriction will affect the supply of the drug
  4. It’s impact on public health

Way Forward

  1. The regulation of drugs has to be rigorous and reasoned
  2. It appears that the government has gone ahead to restrict manufacture without conducting any kind of feasibility study
  3. The case for restricting the manufacture of oxytocin is neither rigorous nor reasoned

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Niti Aayog seeks views on rationalisation of trade margins in medical devices

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Read the attached story

Mains level: Move towards ensuring healthcare access for all.


News

To achieve the overall goal of affordable ‘healthcare for all’

  1. The NITI Aayog in a concept note titled ‘Rationalisation of Trade Margins in Medical Devices—A Concept Note’ said the government intends to make available critical and lifesaving medical devices to the needy masses at affordable prices.
  2. The aim is to ensure reasonable prices to consumers and at the same time allow reasonable profits to all stakeholders in the medical device industry, including those involved in the supply—chain by rationalising trade margins and thereby passing the benefits of the reduced cost to the final consumer.

Considering all Stakeholders Viewpoint

  1. The note pointed out that the issue of unreasonably high trade margins in medical devices has been adversely affecting both the industry as well as consumer interest.
  2. The medical devices industry has been growing at a rapid pace and is currently estimated to have a market size of $10 billion and it is likely to reach a size of $20 billion in next couple of years.
  3. It has been the effort of the government to encourage the medical devices industry and keep it by and large a free and unregulated industry.

Move to cover more Medical accessories

  1. According to the note, Only 23 medical devices have been notified as drugs and are regulated under Drugs and Cosmetics Act.
  2. Of these, only 4 devices viz. cardiac stents, drug eluting stents, contraceptives and intra uterine devices are included in the national list of essential medicines and by virtue thereof are subject to notified price ceilings.
  3. Besides, knee implants have been brought under price control under para 19 of the Drugs (Prices Control) Order 2013.
  4. The remaining medical devices are under no price regulation.

Back2Basics

Drug Price Control Orders (DPCO)

  1. DPCO are issued by the DoP under Ministry of Chemicals and Fertilisers, in the exercise of the powers conferred under section 3 of the Essential Commodities Act, 1955.
  2. This enables the Government to declare a ceiling price for essential and life-saving medicines and ensure that these medicines are available at a reasonable price to the general public.
  3. The latest DPCO was issued in 2013

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Commission approves modern animal-free testing for drugs

Image source

Note4Students

Mains Paper 3: Science and Technology- developments and their applications and effects in everyday life

Prelims Level: Indian Pharmacopoeia CommissionPyrogen Test and various drug tests, People for the Ethical Treatment of Animals (PETA)

Mains Level: Rising concerns for animals rights and various initiatives for their protection


News

Animal-free tests

  1. In a step that would spare animals from suffering due to drug experiments, the Indian Pharmacopoeia Commission has approved modern, animal-free tests for drug manufacturers
  2. In the 2018 edition of Indian Pharmacopoeia, that provides guidelines on tests for drugs manufactured and marketed in India, the IPC has replaced the pyrogen test carried out on rabbits and the abnormal toxicity test carried out on guinea pigs and mice with tests that can be done in test tubes
  3. The guidelines in the edition will come into effect from July 1

New mandate

  1. With the Indian Pharmacopoeia Commission’s new mandate, the pyrogen test will be replaced by a bacterial endotoxin test or a monocyte activation test which can be carried out in test tubes
  2. Vaccine manufacturers can apply for a waiver for the abnormal toxicity test by getting a compliance certificate from the National Control Laboratory instead
  3. People for the Ethical Treatment of Animals (PETA) India has been pushing for doing away with the cruel methods of testing on animals for the past several years

Back2Basics

Pyrogen Test

  1. The pyrogen test is carried out to check impurity or substance that can cause adverse side-effects
  2. For the test, the drug is injected into a rabbit and the animal is closely observed for feverish symptoms
  3. The abnormal toxicity test is carried out to check potential hazardous biological contamination in vaccine formulations
  4. This batch test is done before the product is approved for marketing. In this, mice or guinea pigs are injected with the vaccine. The scientists observe if there is the death of any animal.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Unbranded generics, ‘orphan drugs’ may go out of price control

Note4Students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level:  Drug (Prices Control) Order, 2013, Definition of Orphan Drug, Unbranded drugs, Rare Diseases

Mains level:  National Pharmaceutical Pricing Authority (NPPA)’s concerns over dilution of its power


News

Draft Pharma Policy, 2017

  1. It proposed changes by the department of pharmaceuticals (DoP) for conferring absolute powers to itself for:
  • creating the National List of Essential Medicines (NLEM) and deciding which drugs should be excluded from price control;
  • bringing all strengths and dosages of specified drugs under price control;
  • doing away with the “retail price” and having only the “ceiling price” for non-scheduled products, thereby expanding its span of control

Suggestions in the policy

  1. The policy suggests that NPPA be assisted for pricing by the advisory body with doctors, pharmacists, civil society representatives, industry representatives and government representatives as its members
  2. It suggests creating appellate against the decisions of NPPA with the higher judiciary
  3. However, NPPA sought it as dilution of its authority
  4. It argued that Drugs are not commodities, given statutory status to NPPA under the new affordable healthcare Act

What is NITI Aayog’s proposal?

  1. Along with restructuring NPPA, the Central government is considering giving itself powers to exempt ‘orphan drugs and unbranded generic drugs from price control
  2. Currently, Para 32 of the Drug (Prices Control) Order, 2013, gives the power to NPPA to exempt a certain class of drugs from price control
  3. The government is currently discussing a NITI Aayog proposal, to amend Para 32 to add orphan drugs, unbranded generic drugs and any other drugs decided by the proposed Standing Committee on Affordable Medicines and Health Products.
  4. This proposal is likely to be implemented whenever NPPA is restructured.

Objections by NPPA

  1. The Central government is likely to form a Standing Committee on Affordable Medicines and Health Products which will consist of its officials only
  2. This committee may be given the powers to exempt certain drugs from price control through amended DPCO who is privy to the discussions.
  3. The proposal to exempt “orphan drugs” from price control runs counter to the NPTRD submitted in the Delhi High Court in May 2017
  4. The policy itself was an outcome of orders passed by the Court in cases filed by patients struggling to access highly priced drugs
  5. As a result, the chief policy recommendation was setting up of a 100 crore corpus for funding treatment of rare genetic diseases between the center and states, which is still not functional.
  6. The NITI Aayog is proposing that these very same treatments may be exempted from price control, which undermines and endangers the purpose of affordable healthcare.

Back2Basics

Drug Price Control Orders (DPCO)

  1. DPCO are issued by the DoP under Ministry of Chemicals and Fertilisers, in the exercise of the powers conferred under section 3 of the Essential Commodities Act, 1955.
  2. This enables the Government to declare a ceiling price for essential and life-saving medicines and ensure that these medicines are available at a reasonable price to the general public.
  3. The latest DPCO was issued in 2013.

What are Orphan drugs?

  1. The National Policy for Treatment of Rare Diseases (NPTRD), 2017 defines Orphan Drugs as the very expensive drugs used to treat rare diseases.
  2. As the number of persons suffering from rare diseases is very small, the pharmaceutical companies do not find it viable to develop and sell drugs for them. Therefore, these drugs are called ‘orphan drugs’.
  3. Pharma companies do so to recoup the cost of research and development.

What are Unbranded Generic drugs?

  1. The unbranded generic drugs may be exempted from price control because it is important to give an incentive to drug manufacturers to produce more and more unbranded generics.
  2. Unbranded generic drugs are comparatively cheaper than branded ones.
  3. Currently, most of the drugs sold in India are branded generic drugs.
  4. When Paracetamol is sold under the brand name ‘Calpol’ or ‘Crocin’, it is called a branded generic drug. But when it is sold as ‘paracetamol’ itself, it is called an unbranded generic drug.

What are Rare Diseases?

  1. India does not have a definition of rare disease. However, World Health Organization (WHO) defines rare disease as often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1,000 population.
  2. Some common rare diseases are Haemophilia, Pompe disease, Thalassemia, Sickle-cell Anaemia and Gaucher’s disease
  3. India has recorded 450 of such rare diseases, according to the NPTRD 2017

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

India rejects U.S. request on medical device price caps

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: National Pharmaceutical Pricing Authority (NPPA) and recent list of notified drugs/ equipment under price ceilings

Mains level: India’s efforts for providing affordable universal health care and issues related to it


US objects over India’s Price Capping

  1. US Trade Representative wrote to the PMO and Trade Minister urging them to not expand price controls to additional medical devices as U.S. firms are affected by price controls imposed last year
  2. The USTR is currently reviewing India’s eligibility under its Generalized System of Preferences (GSP),
    which allows duty-free imports of certain goods as India was the largest GSP beneficiary at $5.6 billion
  3. India has told the United States it won’t abstain from capping prices for more medical devices, regardless of pressure to rethink its stance as it would violate India’s move for affordable medical treatment for all

Why such request by the USA?

  1. The government last year capped prices of high-end heart stents, a small wire-mesh structure used to treat blocked arteries — at around $450, compared to $3,000 charged earlier
  2. Now NPPA has urged the Govt for capping prices for some medical devices like- cardiac balloons, catheters, guide-wire and intraocular eye lenses

Back2Basics

National Pharmaceutical Pricing Authority

  1. NPPA is a regulatory agency under Ministry of Chemicals and Fertilizers of India which was established to fix/ revise the prices of controlled bulk drugs and enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995
  2. It renders advice to the Central Government on changes/ revisions in the drug pricing policy
  3. It regularly publishes lists of medicines and their maximum ceiling prices
  4. It is also entrusted with the task of recovering amounts overcharged by manufacturers for the
    controlled drugs from the consumers
  5. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[pib] National Biopharma Mission

Note4Students

From UPSC perspective, the following things are important:

Prelims level: National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC)

Mains level: Developments in biotech sector


News:

  • Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT), Ministry of Science & Technology has initiated the Mission programme entitled: Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals – “Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation”.

Implemented by:- Biotechnology Industry Research Assistance Council (BIRAC) – a Public Sector Undertaking of Department of Biotechnology (DBT)

Aim: To make India a hub for design and development of novel, affordable and effective biopharmaceutical products such as vaccines, biologics and medical devices for combating public health concerns. This Programme of DBT would strengthen

  • Translational capability of academic researchers
  • Empower bio-entrepreneurs and SMEs by decreasing the cost and risk during early stages of product development
  • Elevate the innovation quotient of the industry

The global experience of World Bank would be instrumental in building sustained global linkages, technical assistance and knowledge flow between public private partners for business promotion in biotech sector

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt set to bring Tramadol under NDPS Act

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Tramadol, Narcotics Drugs and Psychotropic Substances (NDPS) Act, Narcotics Control Bureau (NCB), Central Drugs Standard Control Organization (CDSCO), Drugs and Cosmetics Act

Mains level: Drug abuse in India & its impact on society and economy


Keeping more vigil on painkiller drug

  1. The government is all set to bring Tramadol, a painkiller, under the ambit of the Narcotics Drugs and Psychotropic Substances (NDPS) Act
  2. The move is aimed at checking its abuse

Why this decision?

  1. The Narcotics Control Bureau (NCB) raised concerns about the abuse and trafficking of pharmaceuticals in a recent meeting held at the Central Drugs Standard Control Organization (CDSCO)
  2. It suggested that the availability of Tramadol be substantially reduced in order to track its movement in the market
  3. At the Drug Consultative Committee (DCC) meeting, the NCB suggested manufacturing of Tramadol and codeine-based cough syrups in small batches to enable authorities to track the manufacturer

Difference between NDPS Act & Drugs and Cosmetics Act

  1. The NDPS provides for strict imprisonment and fine for offenders
  2. NDPS Act treats drug offenses very seriously and penalties are stiff, whereas Drugs and Cosmetics Act deal with the quality of the drug

Back2Basics

Narcotics Control Bureau (NCB)

  1. The Narcotics Control Bureau (NCB) is the nodal drug law enforcement and intelligence agency of India responsible for fighting drug trafficking and the abuse of illegal substances
  2. It was created on 17 March 1986 to enable the full implementation of The Narcotic Drugs and Psychotropic Substances Act, 1985 and fight its violation through the Prevention of Illicit Trafficking in Narcotic Drugs and Psychotropic Substances Act, 1988
  3. The law was established to fulfill India’s treaty obligations under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances
  4. NCB is affiliated to Home Ministry
  5. The chief purpose of the Narcotics Control Bureau is to fight drug trafficking on an all-India level
  6. The NCB also monitors India’s frontiers to track down points where smuggling activities take place with foreign traffickers
  7. The Narcotics Control Bureau is also represented on the Economic Intelligence Council
  8. The Economic Intelligence Council is the apex forum overseeing government agencies responsible for economic intelligence and combating economic offenses in India

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

India to push for local manufacturing of APIs, reduce dependence on China

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Active pharmaceutical ingredients (APIs

Mains level: India’s dependency on China for various pharma products and rare earth minerals and its impacts


Make in India in pharma required

  1. The chemicals and fertilizers ministry has joined hands with other ministries to draw up a roadmap for increasing active pharmaceutical ingredients (APIs) production in the country
  2. A high-level task force has been constituted to study global practices and draw up a plan aimed at boosting domestic production of APIs

Why such move?

  1. India continues to rely on imports of key starting materials, intermediates and APIs from China, with the share of dependence increasing over time
  2. Currently, over 60% of APIs are sourced from other nations
  3. For some specific APIs, the dependence is over 80-90%
  4. This potentially exposes us to raw material supply disruptions and pricing volatility

Back2Basics

Active Pharmaceutical Ingredients (APIs)

  1. All drugs are made up of two core components: the API, which is the central ingredient, and the excipients, the substances other than the drug that helps deliver the medication to your system
  2. The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects
  3. Excipients are chemically inactive substances, such as lactose or mineral oil
  4. The quality of APIs has a significant effect on the efficacy and safety of medications

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Over-the-counter sale of 14 steroid creams banned by Health Ministry

Back2basics

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Schedule H and X drugs.

Mains level: The Drugs and Cosmetics Act, 1940 and the reasons behind the banning of  over-the-counter sale of 14 products.


News

Decision taken by the Health Ministry

  1. The Union Health Ministry has banned over-the-counter sale of 14 products
  2. Why: To prevent the indiscriminate sale of ointments containing steroids and antibiotics without prescription
  3. The decision was taken under the Schedule H of the Drugs and Cosmetics Rules, 1945
  4. The Drugs and Cosmetics Rules, 1945 are the set of rules under the Drugs and Cosmetics Act, 1940 which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule
  5. The decision was taken following consultation with the Drugs Technical Advisory Board
  6. The board has also submitted their recommendations to the Central Drugs Standards Control Organisation

Background

  1. The move comes after dermatologists complained that pharmaceutical companies were selling steroid-based creams to patients, who use them without medical guidance
  2. Some ointments that have been banned are alclometasone, beclomethasone, desonide and fluocinonide among others

Back2basics

Schedule H drugs

  1. Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945
  2. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor
  3. The manufacture and sale of all drugs are covered under the Drugs and Cosmetics Act and Rules
  4. It is revised at times based on the advice of the Drugs Technical Advisory Board, part of the Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare
  5. However, enforcement of Schedule H laws in India is lax, compared to the more restrictive Schedule X, for which a mandatory documentation trail must be maintained

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt tells NPPA to act on stent makers’ pleas

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: NPPA, DIPP, GSP, etc.

Mains level: Background of the issue. And the steps taken by the government to solve the issues of multinational stent makers..


News

What is the issue?

  1. The Department of Pharmaceuticals (DoP) has called for faster processing of applications by foreign stent makers to withdraw their products from India,
  2. or alternatively, reconsider their petition demanding differential pricing of stents

High-level meeting by Indian officials

  1. At a meeting called by DoP with officials from National Pharmaceutical Pricing Authority (NPPA), Department of Industrial Policy & Promotion (DIPP) and the ministries of health and commerce, the DoP secretary asked the NPPA
  2. to “examine” and “dispose of” the applications filed by multinational stent makers without any further delay”

Background

  1. The move comes ahead of a key meeting on 9 April by the US trade representative (USTR)
  2. The American medical device makers had also asked the USTR to suspend or withdraw India’s benefits under GSP
  3. The US is pressing India not to extend price caps on medical devices and wants India to allow firms to withdraw products from the market if they do not wish to sell at government determined rates

What is generalized system of preferences (GSP)?

  1. Under the GSP, Indian exports to the US enjoy lower import tariffs compared to those imposed on non-GSP exporters

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt plans ban on sale of fairness creams containing steroids

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Corticosteroid

Mains level: Side effects of using fairness creams containing Corticosteroid.


News

Banning of over-the-counter sales of steroid-laced fairness creams

  1. The ministry of health and family welfare is all set to regulate over-the-counter sale of fairness creams carrying corticosteroids
  2. Corticosteroid is a steroid hormone known to cause severe skin damage and other health hazards

Detection of these steroids

  1. Some fairness cream makers add corticosteroids due to their effectiveness in lightening skin colour
  2. Dermatologists say it is impossible to find out how many brands use these steroids as manufacturers do not mention them on their packs, in breach of labelling rules

Why is this step needed?

  1. Dermatologists found a link between using these creams and cases of Topical Steroid Damaged Face (TSDF)’ s type of skin damage due to steroid-laced creams as well
  2. Dermatologists say that simple skin ailments are now becoming almost non-treatable due to the widespread use of creams that contain a cocktail of steroids
  3. There’s also an increase in the number of patients who are showing the side-effects of steroid use
  4. In fact, just to get a few shades fairer, you may be inviting serious side-effects and potentially grave infections, say dermatologists
  5. The matter was taken up by the drug technical body-Drugs Technical Advisory Board which recommended inserting steroid-laced fairness cream in schedule H

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Pharma exports do not need regulator’s approval, Govt tells companies

Note4students

Mains Paper 3: Economy | Effects of liberalization on the economy, changes in industrial policy and their effects on industrial growth

From UPSC perspective, the following things are important:

Prelims level: CDSCO

Mains level: Possible benefits of the decision for Indian Pharmaceutical Sector.


News

Important step taken by the government

  1. Pharmaceutical companies will no longer have to obtain a drug regulatory clearance for exporting drugs and medical devices
  2. It is a step taken by the government aimed at making it easier to do business
  3. According to a notice put out by the Central Drugs Standard Control Organisation (CDSCO), all pharma exporters can continue exporting without having to obtain no-objection certificates (NOC) from the regulatory authorities

Background

  1. This facility was earlier available only for pharma exports to the US, Canada, Japan, Australia and European Union

Why was it needed?

  1. India’s pharma exports stood at $16.8 billion in 2016-17 and are expected to grow by 30% to reach $20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India
  2. The move is expected to reduce “unnecessary paperwork” and “corruption”
    Will help in ending unnecessary delay
  3. Even when the manufacturers were obtaining NOC from the CDSCO, the regulatory authorities were not responsible for the quality of the products
  4. So obtaining NOC was only adding to the paperwork and corruption
  5. This move will help end malpractices and unnecessary delay

Back2basics

The Central Drugs Standard Control Organization (CDSCO)

  1. It is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom
  2. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare
  3. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC)
  4. It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed
  5. Though the CDSCO has a good track record with the World Health Organization, it has also been accused of past collusion with independent medical experts and pharmaceutical companies
  6. CDSCO plans to open international offices in Beijing, China

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] NPPA must balance access with innovation

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: NPPA

Mains level: In the past one year, the decisions by the National Pharmaceutical Pricing Authority (NPPA), including price ceilings, have led to intense discussions


News

Insufficient funds for health sector

  1. WHO has revealed last year that several countries that are poorer than India allocated and disbursed significantly more funds to their health sectors
  2. While we spend 1.4% of our national income on health and family welfare, Brazil spends 3.8%

Price capping by the National Pharmaceutical Pricing Authority (NPPA)

  1. The NPPA is a government regulatory agency that controls the prices of pharmaceutical drugs in India
  2. Decisions taken in the last year by the NPPA seem to suggest that capping market prices has become the go-to solution in India
  3. But price ceilings are far from a panacea
  4. Using price ceilings as a policy tool to correct perennial systemic problems in our formal healthcare system will be detrimental to India’s healthcare system
  5. Other than exacerbating the real risk of cutting down supply of medical technologies in the market, a price ceiling does nothing to stop several service providers from recouping their lost profit margins from elsewhere
  6. In the end, patients end up paying the price due to a misguided policy, either through lack of supply in the market, or through higher pricing of complementary medical services

Study on ‘price capping’ in health sector

  1. A recent empirical study found that the price cap on stents led neither to better accessibility of angioplasty procedures, nor to affordability for patients bearing out-of-pocket expenses

Non-availability of new medicines in Indian Market

  1. Indian patients miss out on half of the new medicines that are launched in other countries by at least five years
  2. because of a failure to embrace dynamic competition, the push to weaken intellectual property (IP) rights, and the embrace of populist, market distorting price-control policies

Drug price regulation

  1. According to WHO and Health Action International, more than 50% of the end price of medicine is contributed by components other than the manufacturer’s selling price
  2. Drug price regulation, such as the one instituted by the NPPA recently, is ineffective

What should be done?

  1. For the NPPA, a priority should be to create an enabling environment to ensure that we have improved drugs, innovative devices and timely access to healthcare, irrespective of who the provider is
  2. India is still import-dependent in the technology-intensive segment of the medical equipment industry simply because R&D (research and development) and innovation are not a priority
  3. There is a need to balance access and affordability by inducing more competition on the one hand while encouraging innovation and long-term stability of the sector on the other
  4. A solution the NPPA can consider is price regulation for older technologies that have already been disseminated in the market, rather than distorting the free market for new technologies
  5. Correct formulation and implementation of policies by the agency will have long-lasting consequences for future generations

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] An urgent prescription

Image Source

Note4students

Mains Paper 2: Governance | Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

From UPSC perspective, the following things are important:

Prelims level: Report of the UN High Level Panel Access to Medicines (2016), CL, APIs, etc.

Mains level: Importance of public sector capacity for manufacturing of essential drugs.


News

Growth of Indian Pharmaceutical Sector

  1. Much of this growth took place after India opted for process patenting over product patenting in 1970
  2. This changed to a product patent regime in 2005, providing sufficient time for growth of the generic drug industry in the private sector

What is needed?

  1. Public sector capacity for manufacture of essential drugs and vaccines is very much needed to ensure that our population is not denied access to drugs
  2. Those drugs which Indian private sector is unable to produce or supply at affordable cost
  3. These include drugs where compulsory licences may need to be issued by the government for patent protected drugs or even off-patent drugs which are commercially unattractive to private manufacturers

What is Compulsory licensing (CL)?

  1. CL is a mechanism permitted by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement
  2. The agreement enables countries to issue licences to domestic drug manufacturers to produce and market affordable generic versions of life-saving drugs needed for meeting serious public health challenges that are of extreme urgency
  3. This allows countries to overcome patent restrictions to assure availability of such drugs when the situation demands

Use of the CL by India

  1. India has used the CL route previously to permit two Indian companies, Natco and Cipla, to produce a potent anti-cancer drug nexavar
  2. This enabled a 32-fold reduction in the cost of the drug

Public sector capacity for manufacturing life saving drugs under a CL is the much needed

  1. If the domestic private sector drug manufacturers are not ready to apply for CL, for whatever reason, public sector capacity to seek and utilise such licences becomes indispensable
  2. With the acquisition of Indian drug companies by foreign manufacturers, or ‘strategic alliances’ which place shackles on the Indian partners, public sector capacity becomes more important
  3. Also, the High Level Expert Group Report on Universal Health Coverage for India (2011) clearly articulated the need for strengthening PSUs which have drug manufacturing capability

Issues related to the Active pharmaceutical ingredients (APIs)

  1. APIs needed for drug manufacture (formulation), are now mostly imported from China
  2. This makes India highly vulnerable to disruptions in supply and cost escalations in import
  3. National security demands that we develop both public and private sector capacity within the country, with suitable government support and incentives, to ensure uninterrupted and inexpensive availability of APIs

UN’s suggestion for the pharmaceutical sector

  1. A report of the UN High Level Panel Access to Medicines (2016) called upon countries to safeguard and fully utilise the rights conferred by the TRIPS flexibilities as confirmed by the Doha Declaration of the WTO
  2. India should take the lead in ensuring universal access to affordable drugs through such measures
  3. Investment in public sector capacity is essential to ensure that the country can exercise that leadership even on occasions when the private pharmaceutical sector does not fully align with that objective

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Imaging equipment such as CT scanners may be brought under drugs Act

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Drugs and Cosmetics Act, PC-PNDT Act, CDSCO, Drug Technical Advisory Board

Mains level: Declining child sex ratio and measures to stop this trend


Regulation change for Imaging and endoscopic equipment

  1. Imaging and endoscopic equipment like ultrasound machines, CT scanners, magnetic resonance imaging (MRI) and X-Ray machines are to be brought under the purview of the Drugs and Cosmetics Act
  2. This is being done to ensure that the government can regulate their import, manufacture, and sale
  3. The Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act, 1994 currently regulates the sale of ultrasound machines only to entities registered under the law

CDSCO to be nodal authority

  1. The Central Drugs Standard Control Organization (CDSCO) will become the approving authority for the import, manufacture, and sale of these devices
  2. It is the national regulatory body for Indian pharmaceuticals and medical devices
  3. Companies that deal in these will also have to apply for permission from the Drug Controller General of India, which is responsible for approval of licences

Decision to change provision

  1. The Drug Technical Advisory Board (DTAB) in its meeting on 12 February decided to include ultrasound equipment under the purview of the Drugs and Cosmetics Act, 1940
  2. It is the government’s chief advisory body on drugs

Why regulate ultrasound machines?

  1. Stringent regulation of ultrasound machines is thought to be critical in addressing the drastic imbalance in India’s sex ratio and helping save the girl child
  2. The regulation of ultrasound machines will help prevent the misuse of sex selection techniques used unabated after conception

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

DoP seeks support from other depts to reduce India’s dependence on APIs

Note4students

Mains Paper 2: Governance | Government policies & interventions for development in various sectors & issues arising out of their design & implementation

From UPSC perspective, the following things are important:

Prelims level: Active pharmaceutical ingredients, canalization

Mains level: Dependence of pharma sector on imports


Reducing API imports

  1. The Department of Pharmaceuticals (DoP) has requested other government departments to chip in with measures to curb imports of active pharmaceutical ingredients (APIs) from China
  2. APIs are used as raw material ingredients to prepare finished medicines
  3. India imports 66% of APIs from China

Suggested measures

  1. The DoP has asked the Department of Commerce to check unhindered import of APIs
  2. The Department of Commerce has been asked to put up a system of ‘canalisation
  3. This means forcing the import of APIs through a government corporation
  4. Ministry of Power has been requested to ensure availability of power at cheaper rates for domestic API manufacturing plants
  5. The DoP has petitioned the health ministry to impose higher registration fees on imports
  6. And stipulate time-bound requirements for foreign companies, which are exporting active pharmaceutical ingredients to India, to establish their Indian production facilities

Stringent testing

  1. The DoP has also asked the health ministry to introduce a mandatory system of consignment-wise testing requirement
  2. It would be on similar lines as practiced in China

Back2Basics

Active Pharmaceutical Ingredients (API)

  1. The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects
  2. All drugs are made up of two core components: API and excipient
  3. API is the central ingredient
  4. Excipient is the substance inside the drug that helps deliver the medication to body system
  5. For example, if you have a headache, acetaminophen is the active ingredient, while the liquid in the capsule or the bulk of a pill is the excipient

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Expert committee set up to review 344 banned FDC drugs

Note4students

Mains Paper 2: Governance | Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

From UPSC perspective, the following things are important:

Prelims level: FDCs

Mains level: Background of the issue and SC’s direction on it.


News

Expert committee for fixed dose combination (FDC) drugs

  1. The Drugs Technical Advisory Board (DTAB) has formed an expert committee to review 344 fixed dose combination (FDC) drugs banned in 2015

Background of the issue

  1. In December, the Supreme Court had asked DTAB to review whether these drugs should continue to be sold
  2. The 344 FDCs were banned on the recommendation of the Kokate committee, which was set up to study their safety and efficacy
  3. The ban had affected around 6,000 brands
  4. According to thr SC direction, the new recommendations of the expert sub-committee will be made to the central government within six months
  5. The court also declared that it will direct the committee to clearly specify reasons against each of the FDCs
  6. As to whether it has safety or efficacy problems or lacks therapeutic justification and whether it recommends that the said drug be prohibited, restricted or regulated

What are FDCs?

  1. An FDC drug contains two or more active ingredients in a fixed dosage ratio

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Stent prices to dip as govt. announces cap

Note4students

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Not much

Mains level: More such steps are needed in the Indian Health Sector. For a brief background, you can go through one of our previous newscards Health Ministry’s notice on reducing coronary stent price


News

Announcement on capping trade margins

  1. The National Pharmaceutical Pricing Authority (NPPA) has announced new stent prices, capping trade margin at 8%
  2. And from now on, it will be required to mention the price of catheters, etc.  during billing

Validity of the order

  1. The price of drug-eluting stent (DES) was announced as Rs. 27,890 ex GST and bare metal stent (BMS) as Rs. 7,660 ex GST
  2. The order will be valid till March 13 next year
  3. The current price of DES stands at Rs. 30,180 and BMS at Rs. 7,400

Background

  1. The NPPA maintained that the price fixation was necessary under the failed and exploitive market system characterised by exorbitant, irrational and restrictive trade margin
  2. The revised rates come as the validity of capping prices of coronary stents ends on February 13

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Demand for sub-category of stent

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: NPPA

Mains level: Issues related to drug prices and overall pharma sector


Ensuring consideration of technical superiority

  1. Medical Technology Association of India (MTaI) has demanded that while subjecting them to price capping, the National Pharmaceutical Pricing Authority (NPPA) should create sub-categories for stents
  2. This is to ensure consideration of technical superiority of each category of stent

Background

  1. The NPPA, in one of its most controversial decisions, had fixed the ceiling prices of coronary stents through its notification on February 13, 2017
  2. It was valid for one year

Back2Basics

National Pharmaceutical Pricing Authority (NPPA)

  1. The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that controls the prices of pharmaceutical drugs in India
  2. It was formed on 29 August 1997
  3. The NPPA regularly publishes lists of medicines and their maximum ceiling prices
  4. The latest drug price control order (DPCO) was released in 2013 which has a list of 384 drugs
  5. Functions of NPPA are:
  • To implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegated to it
  • To deal with all legal matters arising out of the decisions of the Authority
  • To monitor the availability of drugs, identify shortages, if any, and to take remedial steps
  • To collect/ maintain data on production, exports and imports, market share of individual companies, profitability of companies etc, for bulk drugs and formulations

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

DCGI bans import of drug ingredients from six Chinese firms

Note4students

Mains Paper 2: Governance | Government policies & interventions for development in various sectors & issues arising out of their design & implementation.

From UPSC perspective, the following things are important:

Prelims level: APIs

Mains level: Possible effects on Indian pharmaceutical sector


News

Banning of Chinese firms

  1. Citing quality issues, India’s drug regulator Drug Controller General of India (DCGI) has banned the import of ingredients of drugs from six major Chinese pharmaceutical firms
  2. The alert follows an inspection of seven manufacturing units in China that supply the bulk of APIs(active pharmaceutical ingredients) required by Indian pharma firms
  3. The inspections were carried in November last year, following which DCGI cancelled the import registration of six of these firms
  4. Along with this, DCGI also cancelled around 100 import licences of Indian companies which were buying APIs from these Chinese companies
  5. According to DCGI, “non-compliances” were observed by the Indian inspection team that visited China.

What are APIs?

  1. APIs are a drug’s central, chemically active ingredients that produce the intended therapeutic effect on a patient.
  2. According to the Central Drug Standards control Organisation (CDSCO) , India imports about 84% of the APIs it needs

Possible effects of the decision

  1. The move, could have serious ramifications for the Indian pharma industry
  2. Even leading to possible shortages of antibiotics, and anti-diabetes, anti-psychotic and antacid drugs
  3. DCGI’s regulatory sanctions have triggered concerns about the quality of APIs supplied by these firms to India, one of the biggest markets

Government’s view

  1. Officials in CDSCO though say alternative products are available and there won’t be any shortage
  2. According to officials, all penicillins come from China, but we don’t see any shortage to an immediate effect

 

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Drug regulator to make ‘stability testing’ a must for all medicines sold in India

Note4Students

Mains Paper2 | Issues relating to development and management of Social Sector/Services relating to Health,

Prelims: Stability Testing, Drug Consultative Committee

Mains level: The news card talks about the recent proposed amendment by the India’s drug regulator in the Drugs and Cosmetics Rules, 1945, to make “stability testing” mandatory for all drugs sold in the country before they are deemed suitable for use by patients.


News

Context

  1. India’s drug regulator is set to propose amendments to the existing Drugs and Cosmetics Rules, 1945, to make “stability testing” mandatory for all drugs sold in the country before they are deemed suitable for use by patients.
  2. Earlier in November 2013 the Drug Consultative Committee, which comprises state drug regulators, reached a consensus on the need to make stability testing compulsory.

What Impact the rules will have on Pharma Companies?

  1. Once the rules take effect, pharma companies will have to subject their products to quality tests to make sure that drugs do not lose their potency and the expiry dates printed on the packaging are based on the test results.
  2. Also random checks will be done from the samples picked up from the market and if any discrepancies are found, the companies will have to shell out fines and may lose their license.

Stability testing

  1. Mandated around the world, stability testing is the process of subjecting drugs to different tests in varying degrees of temperature and sunlight.
  2. In India, such tests are mandatory only for patented and proprietary drugs.
  3. The Central Drugs Standards Control Organisation (CDSCO) has proposed making stability tests compulsory for all drugs, including active pharmaceutical ingredients (APIs), the raw materials used in a drug that give it a therapeutic effect.

Views of Pharmaceutical Companies on the proposed rules

  1. The pharmaceutical industry is unhappy about the proposal to widen the ambit of the stability tests.
  2. Currently the stability tests are carried out on formulations.
  3. But widening the ambit of stability tests will usher in practical problems because it takes at least 6-9 months to carry out stability tests.
  4. And the pharmaceutical companies are requesting CDSCO to not include all the drugs into it.
  5. CDSCO officials say they are unlikely to yield.

 

 

 

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] The superbugs of Hyderabad

Image source

Note4students

Mains Paper 3: Environment | Conservation, environmental pollution and degradation, environmental impact assessment

From UPSC perspective, the following things are important:

Prelims level: Drug-resistant superbugs, pathogenic bacteria, carbapenems,

Mains level: National Action Plan for Antimicrobial Resistance 2017- key features


Context

Superbugs developing

  1. Effluent from pharmaceutical companies contain high concentrations of antibiotics that are turning the Hyderabad city’s lakes and sewers into breeding grounds of drug-resistant superbugs
  2. Since the pharmaceutical industry took root in the city in the 1970s, environmental pollution has threatened agriculture, aquaculture and the health of city residents
  3. New research in the last few years shows this pollution to be a threat of a larger, more terrifying scale

A whole new species of danger

  1. The Kazipally well, along with ditches, lakes, and rivers around the pharmaceutical cluster, receives large doses of antibiotics, along with the traditionally monitored pollutants
  2. When these antibiotics come in contact with pathogenic bacteria (which cause disease in humans), the latter learn to resist the former, making human infections by these pathogens extremely hard to treat
  3. Antibiotic resistance is arguably the biggest threat to global health in the 21st century
  4. In 2014, around 700,000 people across the world died due to infections that evaded antibiotics, a number that is estimated to touch 10 million by 2050

Studies in India

  1. It isn’t clear how many Indians die from antibiotic-resistant infections each year
  2. One study from Delhi’s Ganga Ram hospital found that between 2002 and 2009, among patients infected by Klebsiella pneumoniae (a pneumonia-causing bacterium), the percentage of these pathogens that were resistant to carbapenems grew from 2% to 52%
  3. Carbapenems are a class of last-resort antibiotics which doctors use only when others have failed

What causes antibiotic resistance?

  1. A big driver of resistance is the overuse of these drugs
  2. When people take antibiotics they don’t need, for a viral flu, for instance, the bacteria in their body learn to tolerate these drugs by acquiring resistance genes
  3. Resistance genes don’t come out of nowhere – some of them have existed for decades in soil and water, helping environmental bacteria fight natural antibiotics
  4. Studies in Hyderabad’s pharmaceutical cluster now show that the large doses of man-made antibiotics in pollution hotspots like Kazipally force these environmental bacteria to evolve by boosting the numbers of resistance genes
  5. When human pathogens like Staphylococcus aureus (which causes skin and respiratory infections), mix with these environmental bacteria, they borrow these genes freely, making them potential killers

Government regulations to control antibiotic pollution

  1. As of today, India does not limit antibiotics in pharma waste water
  2. India’s first concrete move to tackle the problem was the 2017 National Action Plan for Antimicrobial Resistance, which talks about imposing limits on antibiotics in industrial waste
  3. But these regulations are at least three years away

What can antibiotic resistance lead to?

  1. The cost of antibiotic resistance will be enormous for both India and the world
  2. One estimate puts the expense of treating a resistant bloodstream infection at ₹42,000 more than a susceptible infection
  3. This could devastate the healthcare system, which today takes antibiotics for granted

What can be done?

  1. Complying with pollution norms
  2. The cost of better pollution-control isn’t that high
  3. Complying with pollution norms doesn’t need more than 3-4% of the production cost

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] India’s pharmaceutical research problem

Note4students

Mains Paper 3: Science & Technology | Science and Technology- developments and their applications and effects in everyday life Achievements of Indians in science & technology; indigenization of technology and developing new technology

From UPSC perspective, the following things are important:

Prelims level: Particulars of the IPRs and Patent Systems

Mains level: India is a leading pharmaceutical manufacturer. But still Indian Pharmaceutical Sector needs to grow more.


News

Context

  1. The article talks about issues which are halting the progress of Pharmaceutical Sector in India

Biggest Challenge

  1.  One of the biggest constraints to advancing scientific research is the lack of sufficient funding and inadequate allocations by the government
  2. At 0.83% of GDP, India is among the countries with the lowest investment in scientific research

An industry study of 2016 

  1. It examined the extent to which public investment, IPRs and drug pricing policies in 56 countries actively contribute to or detract from innovation in global life-sciences
  2. India ranked among the lowest (in the bottom five) due to weak IP protection, lack of data protection for biologics, low investment in R&D and price regulations
  3. All of these contribute to reduced revenue and therefore reduced future investment in biopharmaceuticals

Survey of biomedical investment attractiveness of countries

  1. India ranked No.19 in this 28-nation survey 
  2. Five metrics were used to determine these rankings
    (1) scientific capabilities and infrastructure
    (2) clinical research conditions and framework
    (3) regulatory system
    (4)  market access and financing
    (5) effective intellectual property protections
  3. India scored low on almost all metrics except for partial step-ups on scientific capabilities and infrastructure, and clinical research conditions and framework

 

Good Chance for India to become R&D Powerhouse

  1. Rising cardiovascular problems and other chronic diseases, make India a strong candidate to become a future powerhouse of R&D and manufacturing in pharmaceuticals
  2. In addition, clean water, rising incomes and better health infrastructure for the nation are contributing to an ageing population
  3. This population will cause a greater demand for different types of pharmaceutical drugs

Low R&D investment as a percentage of sales

  1. The R&D investment as a percentage of sales has been rising for several years and now stands at 6% for some Indian companies
  2. But it is still well short of the 20% typical of Western pharma companies
  3. Moreover, innovation in chronic diseases and rare diseases has not yet taken off

Issues with Indian Education System

  1. The education system is to blame as well, imparting theoretical knowledge with no emphasis on product development and application of theory
  2. This leads to the deterioration of the knack(capability) for problem-solving and innovation
  3. Those who manage to keep their enthusiasm alive for research have to deal with the lack of facilities or face delayed funding issues
  4. Educational and academic institutions should be encouraged to participate in research programmes with funding from both the government as well as the private sector

What we need?

  1. We need four pillars for strengthening the innovation environment in the biopharmaceutical industry
    (1) human resources
    (2) finances
    (3) infrastructure
    (4) legal and regulatory framework
  2. Each of these pillars needs a concerted focus and a long-term commitment from industry as well as the government
  3. The environment to support the development of these verticals could emerge through our various government-led initiatives such as Skill India, Make in India, Atal Innovation Mission, etc.

The Way Forward

  1. In order to support consistent innovation, investment has to increase substantially before any tangible outcomes can be envisioned
  2. A strong patent system and robust IPRs environment is required to encourage research and to enable foreign pharma companies to bring new products to the market
  3. Without the requisite investment and enabling policy environment, patients in India will continue to suffer due to lack of access to cutting-edge medicines and new diagnostics

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Child-friendly HIV drug gets govt. nod

Note4students:

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources

This is a significant achievement and will reduce the prevalence of HIV in India in future.

From UPSC perspective, following things are important:

Prelims Level: Read about Lopinavir and the agencies associated with it

Mains Level: Note down the advantages of this move and the reasons for gap in treatment.


Context:

  1. The Central Drugs Standard Control Organisation (CDSCO) has registered the child-friendly HIV drug in
    oral pellet form
  2. This has opened up crucial supplies from Cipla Pharmaceuticals, a market leader in the HIV segment
  3. The National AIDS Control Programme (NACO) had been struggling to source quality assured paediatric
    formulations of the drug

What happened with Lopinavir?

  1. India ran out of Lopinavir syrup, a child-friendly HIV drug, in March
  2. This happened after Cipla, the sole manufacturer of the drug, stopped production
  3. This was a result of the non-payment by the Health Ministry
  4. The drug’s adult version has to be swallowed whole. It cannot be administered to infants and young children

Expert Committee’s intervention

  1. An expert committee of the CDSCO had permitted the child-friendly and heat-stable pellet formulation of the
    HIV drug lopinavir/ritonavir (LPV/r)
  2. The pellets come in capsules and are dosed by weight
  3. It can be sprinkled (but not stirred or crushed) over a small amount of soft food
  4. Infants must be able to swallow them, the pellets can be added to a spoonful of breast milk or put on the infant’s tongue

Why the treatment gap?

  1. The lack of child-friendly HIV formulations is one of the major reasons why there is such a large treatment gap
    between adults and children
  2. This is also why we consider pediatric HIV to be a neglected disease

Children and HIV

  1. The registration of the pellets is a positive sign as the needs of children are being addressed
  2. Children are some of the most vulnerable HIV patients, and we cannot forget their special R&D needs
  3. The lack of child-friendly drugs is a major reasons for the treatment gap between adults and children

Back2basics:

NACO

  1. The National AIDS Control Organisation (NACO) was established in 1992
  2. It is a division of India’s Ministry of Health and Family Welfare
  3. It provides leadership to HIV/AIDS control programme in India through 35 HIV/AIDS Prevention and Control
    Societies
  4. NACO is the nodal organisation for formulation of policy and implementation of programs for prevention and
    control of HIV/AIDS in India
  5. In 2010, NACO approved the TeachAIDS curriculum for use in India
  6. It is an innovation which represented the first time that HIV/AIDS education could be provided in a curriculum which did not need to be coupled with sex education

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Delhi HC sets aside Centre’s decision to ban 344 fixed dose combination drugs

  1. Delhi High Court on Thursday set aside the Union government’s decision to ban 344 fixed-dose combination (FDC) drugs, including well known names like Corex, a cough syrup, Vicks Action 500 and D’Cold
  2. The government had banned the drugs on the grounds that they involve “risk” to humans and safer alternatives were available
  3. It’s not over yet: Before this judgment, the government had moved a petition at the Supreme Court to transfer all FDC-related matters being heard in the country so that they could be clubbed and heard afresh

Back2basics:

What is a Fixed Dose combination?

  1. An FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
  2. FDCs are desirable here for their effectiveness in treating many symptoms of illness at a lower cost than two or more separate medicines.

Note4students:

Wait and watch as this debate enfolds. The counter argument by companies was that their brands had been in the market for decades, with some even producing no objection certificates (NOCs) granted by the central drug regulator for their combinations. If NOCs etc. are not being honoured by govt. would this not go against the private-public trust?

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Pricing norms outdated, says NPPA chief

  1. NPPA: The Drug Price Control Order (DPCO) is outdated and has to be amended
  2. Why? Amendment will help facilitate the National Pharmaceutical Pricing Authority (NPPA) look into subjects like biosimilars and medical devices like stents
  3. Currently, NPPA doesn’t have market data for 350 medicines that come under price control

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Drug price revision by NPPA

  1. News: The National Pharmaceutical Pricing Authority (NPPA) has revised the prices of 22 scheduled drugs for treating malaria, HIV, asthma, breast cancer, among others
  2. Background: NPPA had fixed the ceiling price for 123 medicines in July; and overall, since April of this year, it has put fresh ceiling prices for a total 316 drugs
  3. Stents: NPPA has now taken up the task of working out the prices of stents as well which are now officially considered drugs and come under the ambit of NPPA

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Policy on bulk drugs soon

  1. Department of Pharmaceuticals is working on a policy for bulk drugs
  2. The department has taken into considerations all recommendations of V M Katoch committee
  3. It was constituted in 2013 to study the whole issue of active pharmaceutical ingredients of critical importance
  1. Department of Pharmaceuticals is working on a policy for bulk drugs
  2. The department has taken into considerations all recommendations of V M Katoch committee
  3. It was constituted in 2013 to study the whole issue of active pharmaceutical ingredients of critical importance

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt to develop 6 bulk drugs, medical devices parks- II

  1. The drug parks will be established on the public private partnership mode
  2. Govt is also considering to provide one-time financial support for these bulk drug parks
  3. They will have common facilities like testing, power and effluent treatment plants
  4. Also, there will be common utilities and services such as storage, testing laboratories, IPR management, designing and guest house/accommodation, maintained by a separate special purpose vehicle
  1. The drug parks will be established on the public private partnership mode
  2. Govt is also considering to provide one-time financial support for these bulk drug parks
  3. They will have common facilities like testing, power and effluent treatment plants
  4. Also, there will be common utilities and services such as storage, testing laboratories, IPR management, designing and guest house/accommodation, maintained by a separate special purpose vehicle

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt to develop 6 bulk drugs, medical devices parks- I

  1. Govt of India has decided to establish three bulk drugs and three medical devices parks, which will entail a combined investment of Rs. 60,000 crore
  2. Aim: To reduce import
  3. Estimates: Once these parks become operational, they can bring down the cost of production of devices and bulk drugs by at least 30%
  4. In the long-run, this will help the general public also
  5. Need: As much as 80% of our total requirement of bulk drugs and 65% of total demand of medical devices is met through imports
  1. Govt of India has decided to establish three bulk drugs and three medical devices parks, which will entail a combined investment of Rs. 60,000 crore
  2. Aim: To reduce import
  3. Estimates: Once these parks become operational, they can bring down the cost of production of devices and bulk drugs by at least 30%
  4. In the long-run, this will help the general public also
  5. Need: As much as 80% of our total requirement of bulk drugs and 65% of total demand of medical devices is met through imports

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Indian drug firms will face challenges in U.S.

  1. News: According to ICRA, Indian pharma companies will face a number of challenges in the U.S. market
  2. Background: Indian pharma sector registered strong growth, driven mainly by the US market, on account of large brands going off patent
  3. Challenges: Reduced no. of big products going off patent, increased competition and rise in regulatory scrutiny
  4. Impact: The growth from US market has now come down from high double digits to 8-10%
  1. News: According to ICRA, Indian pharma companies will face a number of challenges in the U.S. market
  2. Background: Indian pharma sector registered strong growth, driven mainly by the US market, on account of large brands going off patent
  3. Challenges: Reduced no. of big products going off patent, increased competition and rise in regulatory scrutiny
  4. Impact: The growth from US market has now come down from high double digits to 8-10%

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Drug makers body says govt’s ban ‘arbitrary and unfair’

  1. Context: Govt.’s decision to ban 344 fixed dose combination medicines, including few cough syrups
  2. News: Indian drug manufacturers’ association said that there was no proper discussion with the industry before the ban
  3. Criticism: The amount of time, money and environmental impact in destroying these procedures will be huge
  1. Context: Govt.’s decision to ban 344 fixed dose combination medicines, including few cough syrups
  2. News: Indian drug manufacturers’ association said that there was no proper discussion with the industry before the ban
  3. Criticism: The amount of time, money and environmental impact in destroying these procedures will be huge

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Alternative to Small Molecule Drugs

  1. Context: BioPharmaceuticals provide an alternative to Small Molecule Drugs for Novel Treatments of previously Untreatable Diseases
  2. These drugs provide affordable options for addressing the healthcare needs of humankind
  3. R&D: Department of Biotechnology (DBT) is supporting cutting edge research for development of new Biopharmaceutical drugs in different universities, research institutes
  4. Through Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector of DBT, a number of Start-ups, SMEs and Biotech companies are developing such new drugs
  1. Context: BioPharmaceuticals provide an alternative to Small Molecule Drugs for Novel Treatments of previously Untreatable Diseases
  2. These drugs provide affordable options for addressing the healthcare needs of humankind
  3. R&D: Department of Biotechnology (DBT) is supporting cutting edge research for development of new Biopharmaceutical drugs in different universities, research institutes
  4. Through Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector of DBT, a number of Start-ups, SMEs and Biotech companies are developing such new drugs

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Bulk drug policy to be unveiled

  1. News: Govt. is expected to come out with a new bulk drug policy in less than a month
  2. Background: India has now become a superpower in the generic drugs
  3. Objective: To grow the Indian pharmaceuticals sector to a $200 billion industry by 2030
  4. The govt wants to build an ecosystem to help pharma comapnies go up the value chain
  5. Organisation: Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers
  1. News: Govt will come out with a new bulk drug policy in less than a month
  2. Background: India has now become a superpower in the generic drugs
  3. Objective: To grow the Indian pharmaceuticals sector to a $200 billion industry by 2030
  4. The govt wants to build an ecosystem to help pharma comapnies go up the value chain
  5. Organisation: Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

India’s drug monitoring programme struggles to grow fast enough

  1. Challenges: Insufficient staff and equipment and a lack of awareness among medical professionals
  2. Unrecorded: many potentially dangerous drug reactions go unrecorded
  3. Lack of data: Gaps in the system mean the government has less data
  4. Effect: inability to determine whether drugs might have harmful side effects
  5. WHO database: Also, relatively little information flows to the WHO database of over 12 million suspected adverse drug reactions
  1. Challenges: Insufficient staff and equipment and a lack of awareness among medical professionals
  2. Unrecorded: many potentially dangerous drug reactions go unrecorded
  3. Lack of data: Gaps in the system mean the government has less data
  4. Effect: inability to determine whether drugs might have harmful side effects
  5. WHO database: Also, relatively little information flows to the WHO database of over 12 million suspected adverse drug reactions

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Customs duty on life saving drugs unlikely to affect patients

  1. This is because Indian companies are already producing these 15 drugs as generics
  2. Moreover, 6 of 15 drugs in the list (including Anti Rabies and Anti-D Immunoglobulin) already fall under the government’s price control order
  3. However, it is more viable for them to export the same drugs than sell domestically
  4. The govt tries to strengthen the taxation structure to increase domestic production
  5. Domestic bulk drug industry, which was facing a massive downturn due to Chinese imports, has got some relief

Govt has imposed a customs duty of 35 % on 15 life-saving drugs but it is unlikely to affect patients

  1. This is because Indian companies are already producing these 15 drugs as generics
  2. Moreover, 6 of 15 drugs in the list (including Anti Rabies and Anti-D Immunoglobulin) already fall under the government’s price control order
  3. However, it is more viable for them to export the same drugs than sell domestically
  4. The govt tries to strengthen the taxation structure to increase domestic production
  5. Domestic bulk drug industry, which was facing a massive downturn due to Chinese imports, has got some relief

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

As customs duty exemption goes, 76 life-saving drugs to get costlier

  1. The Finance Ministry has withdrawn exemption of 76 medicines from customs duties
  2. Why – To boost domestic competition among Indian drug-makers
  3. Impact – It could inflate the cost of essential life-saving imported drugs
  4. The list includes 10 HIV drugs and at least 4 cancer drugs, but haemophilia patients are likely to be the most affected by the decision
  5. The withdrawal of exemption for anti-cancer and HIV medicines will not affect patients as generic versions of these drugs are made in India
  1. The Finance Ministry has withdrawn exemption of 76 medicines from customs duties
  2. Why – To boost domestic competition among Indian drug-makers
  3. Impact – It could inflate the cost of essential life-saving imported drugs
  4. The list includes 10 HIV drugs and at least 4 cancer drugs, but haemophilia patients are likely to be the most affected by the decision
  5. The withdrawal of exemption for anti-cancer and HIV medicines will not affect patients as generic versions of these drugs are made in India

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Pharma and biotech sector must get its due in Budget

  1. Some of the immediate needs of the sector are access to capital, quality infrastructure, high-end talent
  2. The proposed removal of tax breaks could blunt the India pharma and biotech industry’s ‘innovation’ edge
  3. The tax exemptions given to SEZs and R&D have delivered on their stated objectives and must be further augmented to drive investment, growth and employment
  4. Today, the Indian pharma industry is recognised as the ‘Pharmacy to the World’
  5. It is one of the lowest-cost producers of essential medicines globally, catering to nearly 30% of the demand for generics drugs worldwide
  1. Some of the immediate needs of the sector are access to capital, quality infrastructure, high-end talent
  2. The proposed removal of tax breaks could blunt the India pharma and biotech industry’s ‘innovation’ edge
  3. The tax exemptions given to SEZs and R&D have delivered on their stated objectives and must be further augmented to drive investment, growth and employment
  4. Today, the Indian pharma industry is recognised as the ‘Pharmacy to the World
  5. It is one of the lowest-cost producers of essential medicines globally, catering to nearly 30% of the demand for generics drugs worldwide

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

New U.S. rule a blow to Indian pharma exporters

  1. US govt. has made it mandatory for Active Pharmaceutical Ingredients (APIs) to be manufactured locally.
  2. At present, nearly 80% of drug raw material requirement is met by India or China.
  3. This change will affect companies which have subsidiaries in the US that procure APIs from their Indian counterparts and make the finished product in the US.
  4. Further, the decision would impact availability of affordable generics in the United States.
  5. India’s pharmaceutical Export Promotion Council has asked the govt. to intervene and resolve the issue.
  1. US govt. has made it mandatory for Active Pharmaceutical Ingredients (APIs) to be manufactured locally.
  2. At present, nearly 80% of drug raw material requirement is met by India or China.
  3. This change will affect companies which have subsidiaries in the US that procure APIs from their Indian counterparts and make the finished product in the US.
  4. Further, the decision would impact availability of affordable generics in the United States.
  5. India’s pharmaceutical Export Promotion Council has asked the govt. to intervene and resolve the issue.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Government brings 376 drugs under new list of essential medicines

  1. The Union Government has added 106 drugs including that of HIV/AIDS, Cancer and Hepatitis C to National List of Essential Medicines (NLEM).
  2. In this regard, Union Ministry of Health and Family Welfare’s core committee has revised the NLEM.
  3. The committee was headed by V.M. Katoch, former secretary of Department of Health Research.
  4. The revision includes addition of 106 essential medicines and deletion of 70 medicines.

This move will ensure their availability across the country at affordable prices.

  1. The Union Government has added 106 drugs including that of HIV/AIDS, Cancer and Hepatitis C to National List of Essential Medicines (NLEM).
  2. In this regard, Union Ministry of Health and Family Welfare’s core committee has revised the NLEM.
  3. The committee was headed by V.M. Katoch, former secretary of Department of Health Research.
  4. The revision includes addition of 106 essential medicines and deletion of 70 medicines.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Separate ministry for pharma in next one year: Ananth Kumar

  1. Union Fertilisers Minister said there would be a separate ministry for pharma and medical devices sector in the next 1 year.
  2. The govt. will soon implement the Katoch panel recommendations to cut bulk drugs import from China.
  3. India currently meets about 80% of its demand of bulk drugs, used as raw materials by the pharmaceutical industry, from Chinese imports.
  4. Govt recognises the pharma sector as a sunshine industry having a tremendous potential for growth.
  1. Union Fertilisers Minister said there would be a separate ministry for pharma and medical devices sector in the next 1 year.
  2. The govt. will soon implement the Katoch panel recommendations to cut bulk drugs import from China.
  3. India currently meets about 80% of its demand of bulk drugs, used as raw materials by the pharmaceutical industry, from Chinese imports.
  4. Govt recognises the pharma sector as a sunshine industry having a tremendous potential for growth.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Govt. forms committee to review drug pricing policy

  1. Inter-ministerial committee to review the Drug Price Control Order (DPCO) 2013,
  2. Following Supreme Court verdict that termed drug pricing policy as irrational and unreasonable.
  3. The committee look into the pricing of medicines, and specifically in the market based pricing formula which is being used at present under DPCO 2013.

The committee will look into the pricing of medicines, and specifically in the market based pricing formula.

  1. Inter-ministerial committee to review the Drug Price Control Order (DPCO) 2013,
  2. Following Supreme Court verdict that termed drug pricing policy as irrational and unreasonable.
  3. The committee look into the pricing of medicines, and specifically in the market based pricing formula which is being used at present under DPCO 2013.
  4. The NGO had in a petition said, Market Based Pricing (MBP) was never used for any price regulatory purposes and this making medicines costlier.
  5. As stipulated under DPCO 2013, drug price regulator NPPA fixes the ceiling price of essential medicines of schedule-I.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Bar-coding norm may hit 1,000 pharma companies

  1. Pharmaceutical companies in India are expected to comply with mandatory bar-coding of medicine strips, as per directives of the Commerce Ministry.
  2. From October 1, the medicine strips and containers will be expected to have a “parent-child” relationship.
  3. This means, bar-code will ensure that every unique strip of drug will go into a unique secondary package (containing the primary pack of drugs with safety instructions etc).
  4. Aim is to track the origins of a shipment and to curb the distribution of spurious drugs as those manufactured in India.

The battle for access to affordable Indian generic drugs has a new threat: bar-coding.

  1. Pharmaceutical companies in India are expected to comply with mandatory bar-coding of medicine strips, as per directives of the Commerce Ministry.
  2. From October 1, the medicine strips and containers will be expected to have a “parent-child” relationship.
  3. This means, bar-code will ensure that every unique strip of drug will go into a unique secondary package (containing the primary pack of drugs with safety instructions ).
  4. Aim is to track the origins of a shipment and to curb the distribution of spurious drugs as those manufactured in India.
  5. Nearly 1,000 small and medium-sized pharmaceutical firms, account for 40 per cent of India’s total drug exports will be out of business.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

First malaria vaccine likely by October

  1. The first malaria vaccine candidate to reach phase-3 of clinical testing was found to partially protect children against the disease up to four years after vaccination.
  2. The European Medicines Agency (EMA) will assess the quality, safety, and efficacy of the vaccine.
  3. If licensed, RTS,S/AS01 (that’s the medicine name) would be the first licensed human vaccine against a parasitic disease.
  4. The RTS,S/AS01 vaccine was developed for use in sub-Saharan Africa where malaria still kills around 1300 children every day.
  1. The first malaria vaccine candidate to reach phase-3 of clinical testing was found to partially protect children against the disease up to four years after vaccination.
  2. The European Medicines Agency (EMA) will assess the quality, safety, and efficacy of the vaccine.
  3. If licensed, RTS,S/AS01 (that’s the medicine name) would be the first licensed human vaccine against a parasitic disease.
  4. The RTS,S/AS01 vaccine was developed for use in sub-Saharan Africa where malaria still kills around 1300 children every day.

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Pharma Jan Samadhan: an online portal by Min. of Chem & Fertilizers

  1. Web enabled system for redressal of consumers’ grievances relating to pricing and availability of medicines.
  2. Created by National Pharmaceutical Pricing Authority (NPPA).
  3. Will check the menace of – overpriced medicines|shortage of medicines | sale of medicine without approval of NPPA.
  4. NPPA will initiate action on any complaint within 48 hrs of its receipt.
  1. Web enabled system for redressal of consumers’ grievances relating to pricing and availability of medicines.
  2. Created by National Pharmaceutical Pricing Authority (NPPA).
  3. Will check the menace of – overpriced medicines|shortage of medicines | sale of medicine without approval of NPPA.
  4. NPPA will initiate action on any complaint within 48 hrs of its receipt.
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