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

Aug, 30, 2019

Prohibition of E-cigarettes Ordinance 2019


  • 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.
Aug, 28, 2019

[pib] Janaushadhi Sugam


  • 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.
Aug, 24, 2019

Oxytocin and issues over its commercial use


  • 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, 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.
Aug, 06, 2019

APIs of drugs to get track-and-trace codes


  • 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.
Mar, 27, 2019

Govt. notifies new rules for drugs, clinical trials


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


  • 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.
Feb, 26, 2019

[op-ed snap] The correct prescription


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.



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, 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.

Feb, 11, 2019

All Medical equipment notified as drugs


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


  • 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.



Feb, 04, 2019

At first, Kerala sets up drug price monitor


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


  • 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.
Dec, 18, 2018

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


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


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
Dec, 15, 2018

Govt to set up National Medical Devices Promotion Council


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


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.
Nov, 16, 2018

[pib] Positive Impact of GST on Pharma Sector


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


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.
Sep, 13, 2018

Govt prohibits manufacture, supply, sale of 328 FDC drugs


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.


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.
Sep, 04, 2018

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


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



  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.
Sep, 03, 2018

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


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


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
Aug, 30, 2018

EU, India to collaborate on developing next generation influenza vaccine


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.


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.
Aug, 30, 2018

[op-ed snap] Cure that hurts


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


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


  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
Aug, 27, 2018

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


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


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
Aug, 18, 2018

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


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


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
Aug, 16, 2018

[op-ed snap] Questioning a crackdown


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


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
Jun, 11, 2018

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


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.


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.


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
May, 09, 2018

Commission approves modern animal-free testing for drugs

Image source


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


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


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.
May, 03, 2018

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


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


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.


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
May, 02, 2018

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


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


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.
Apr, 26, 2018

[pib] National Biopharma Mission


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


  • 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

Apr, 25, 2018

Govt set to bring Tramadol under NDPS 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: 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


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
Apr, 21, 2018

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


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


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
Apr, 09, 2018

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


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.


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


  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


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
Apr, 06, 2018

Govt tells NPPA to act on stent makers’ pleas


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..


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”


  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
Mar, 27, 2018

Govt plans ban on sale of fairness creams containing steroids


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.


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
Mar, 22, 2018

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
Mar, 20, 2018

[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
Mar, 14, 2018

[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
Mar, 01, 2018

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
Feb, 27, 2018

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
Feb, 15, 2018

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
Feb, 13, 2018

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
Feb, 06, 2018

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
Jan, 09, 2018

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


Nov, 28, 2017

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.




Nov, 18, 2017

[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
Sep, 16, 2017

[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
Jun, 07, 2017

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
Dec, 01, 2016

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?

Aug, 30, 2016

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
Aug, 20, 2016

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
Jun, 07, 2016

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
Jun, 07, 2016

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
Jun, 07, 2016

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
Apr, 05, 2016

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%
Mar, 19, 2016

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
Mar, 03, 2016

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
Feb, 18, 2016

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
Feb, 16, 2016

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
Feb, 09, 2016

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
Feb, 06, 2016

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
Feb, 05, 2016

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
Feb, 03, 2016

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.
Dec, 28, 2015

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.
Dec, 10, 2015

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.
Nov, 02, 2015

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.
Oct, 16, 2015

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.
Apr, 30, 2015

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.
Apr, 01, 2015

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.
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