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


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.


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


  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


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

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


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


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

[op-ed snap] An urgent prescription

Image Source


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.


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

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


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

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


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


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

Expert committee set up to review 344 banned FDC drugs


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.


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

Stent prices to dip as govt. announces cap


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


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


  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

Demand for sub-category of stent


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


  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


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

DCGI bans import of drug ingredients from six Chinese firms


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


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


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


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.



  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.




[op-ed snap] The superbugs of Hyderabad

Image source


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


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

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


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.



  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

Child-friendly HIV drug gets govt. nod


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.


  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



  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
  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

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


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.


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?

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

Learn about National Pharmaceutical Pricing Authority

  1. A regulatory agency of the Government of India formed in 1997
  2. Functions: To fix/ revise the prices of controlled bulk drugs and formulations
  3. To enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995
  4. Recovering amounts overcharged by manufacturers for the controlled drugs from the consumers
  5. Monitor the prices of decontrolled drugs in order to keep them at reasonable levels

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

What are bulk drugs?

  1. Bulk drugs are also known as active pharmaceutical ingredient (API)
  2. These are the ingredients in a drug that give it its therapeutic effect
  3. India imports almost 90% of its bulk drugs from China
  4. Common imported bulk drugs include painkillers such as paracetamol and aspirin, and antacid ranitidine – known by its trade name of Zantac

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

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

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

What are the components of a drug?

  1. Any drug is composed of two components or aspects.
  2. The first is the actual Active Pharmaceutical Ingredients (API), which is the central ingredient.
  3. The API is the chemically active substance, which is meant to produce the desired effect in the body.
  4. The second is known as an excipient, which are the inactive or inert substances present inside a drug.

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%

Learn about Fixed dose combinations (FDC)

  1. FDCs are formed by combining 2 or more active pharmaceutical ingredients (APIs) in a fixed dose medicine to form a single drug
  2. There are some apprehension on the side-effects of the combined product
  3. API: It is the chemically active substance, which is meant to produce the desired effect in the body

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

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

Bulk drug policy to be unveiled

  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

Learn about Pharmacovigilance Programme?

  1. Context: Monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health
  2. Initiated by: The Central Drugs Standard Control Organisation (CDSCO) in 2010, under Ministry of Health & Family Welfare
  3. Coordinator: All India Institute of Medical Sciences (AIIMS), New Delhi is the National Coordinating Centre (NCC)
  4. Mission: to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use
  5. Need: To engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country
  6. Purpose: to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to health care professionals and the public
  7. Database: collects and submits suspected adverse drug reactions to a WHO database called VigiBase
  8. Indian contribution: Last year, India contributed 2% of the 2.1 million suspected reactions

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

Customs duty on life saving drugs unlikely to affect patients

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

Let’s know about Haemophilia

  1. Haemophilia is a genetic disorder in which the patient tends to bleed excessively
  2. Anti-haemophilic factor concentrates (VIII & IX) are given to patients to control the bleeding
  3. These concentrates are proteins that help the blood clot
  4. Indian patients depend on American pharmaceutical company Baxter International for the proteins

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

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

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.

Did you know about Essential medicines?

  1. Essential medicines are those that satisfy the priority health care needs of the country’s population.
  2. They are generally based on the country’s disease burden, priority health concerns, affordability concerns etc.
  3. In India, NLEM (formed in 2011) decides the essential medicines.
  4. It is a dynamic list and is reviewed every 3 years to include or exclude drugs as relevant to the newest medical innovations and aligned to market competition.

Government brings 376 drugs under new list of essential 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.

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.

Lets know about Katoch Committee recommendations

  1. The govt had set up a committee headed by V. M. Katoch, to suggest ways to reduce the dependence on bulk drug imports from China.
  2. India currently meets about 80% of its demand of bulk drugs from Chinese imports.
  3. There are recommendations like providing land at concessional rates, setting up of mega pharma parks and providing power.
  4. It also includes single window clearance for licensing of drugs in the country and setting up National Bulk Drugs Development Authority.

What is drug price control?

  1. The Centre issued Drugs (Price Control) Order, 2013 to regulate the prices of drugs.
  2. It initially brought under price control 652 medicines or formulations based on 348 bulk drugs listed under the National List of Essential Medicines.
  3. The ceiling price of essential medicines has been fixed based on the weighted average of the prices (MRP) of all brands of that drug that have a market share of at least 1%.
  4. If any medicine is priced lower than the ceiling fixed by the regulator, then companies selling such drugs should maintain the existing or lower retail price.

Govt. forms committee to review drug pricing policy

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.

Bar-coding norm may hit 1,000 pharma companies

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.

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.

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.

:( We are working on most probable questions. Do check back this section.

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