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

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

Strengthening India’s Drug Regulatory Framework for Ensuring Quality Medicines


From UPSC perspective, the following things are important :

Prelims level : NA

Mains level : challenges India's pharmaceutical industry and way forwards


Central Idea

  • The recent incidents of substandard and contaminated medicines in India have raised concerns about the quality and regulatory oversight in the pharmaceutical industry. While India takes pride in being the largest manufacturer of generic medicines globally, it is essential to address the persistent quality concerns to maintain its reputation and protect public health.

Tragic incidents highlighting quality concerns

  • Digital Vision Contamination: In January 2020, 12 children in Jammu died after consuming contaminated medicine manufactured by Digital Vision, revealing the presence of diethylene glycol. Despite previous red flags from drug laboratories, another incident occurred six months later, leading to the death of a two-year-old consuming Cofset cough syrup from the same manufacturer.
  • Nycup Syrup: In March 2021, Nycup syrup was found to have lower levels of the active ingredient, raising concerns about quality control. However, limited regulatory action hindered effective intervention against the manufacturer.

An overview of the drug regulation mechanism in India

  • Central Drugs Standard Control Organization (CDSCO): The CDSCO, under the Ministry of Health and Family Welfare, is the central regulatory authority responsible for the approval, regulation, and control of pharmaceutical products in India. It plays a crucial role in granting licenses, conducting inspections, and monitoring drug manufacturing, import, and distribution.
  • Drug Controller General of India (DCGI): The DCGI is the head of the CDSCO and holds the overall responsibility for drug regulation in India. The DCGI oversees the approval of new drugs, clinical trials, and the regulation of imported drugs.
  • National Pharmaceutical Pricing Authority (NPPA): The NPPA regulates the prices of essential drugs in India to ensure affordability and accessibility. It monitors and controls the prices of scheduled medicines and sets guidelines for the pricing of pharmaceutical products.
  • Pharmacovigilance Program of India (PvPI): PvPI is a national program that focuses on monitoring and reporting adverse drug reactions (ADRs) to ensure the safety of medicines. It encourages healthcare professionals and the public to report any suspected ADRs to a centralized database for analysis and evaluation
  • Intellectual Property Rights (IPR) Protection: The regulatory framework includes provisions to protect intellectual property rights related to pharmaceutical inventions and innovations. This promotes research and development in the industry and encourages the introduction of new drugs.
  • Manufacturing Standards: The CDSCO ensures that drug manufacturers in India adhere to good manufacturing practices (GMP) to ensure that drugs are produced under quality standards and are safe for use.
  • Clinical Trials: The CDSCO regulates clinical trials in India to ensure that they are conducted ethically and with the safety of participants in mind. The CDSCO requires that clinical trials follow the guidelines of the International Conference on Harmonization (ICH).

Challenges in the Indian pharmaceutical industry

  • Fragmented Regulatory Structure: With approximately 36 drug regulators in India, coordination and consistency in regulatory oversight become challenging. A consolidated and centralized regulatory body can mitigate the risk of regulatory capture and ensure common standards across states.
  • Persisting Quality Concerns: Despite being the largest manufacturer of generic medicines globally, India has encountered quality issues. Recent inspections revealed that 48 drugs failed to meet quality standards, jeopardizing patient safety.
  • Global Reputation at Stake: Observations from global regulators, such as the US FDA, indicate compliance issues in Indian pharmaceutical facilities, potentially tarnishing India’s image as a quality drug manufacturing country.
  • Limited Regulatory Action: In some instances, regulatory action has been limited or challenging to implement due to various reasons, making it difficult to effectively address quality issues and hold manufacturers accountable.
  • Insufficient Transparency and Accountability: The lack of transparency in the drug regulatory regime hinders public trust and confidence. Limited public disclosure of drug application reviews, inspection records, and past violations makes it challenging to evaluate the compliance and track record of manufacturers.
  • Inspection and Enforcement Capacity: The sheer number of pharmaceutical manufacturing units in India, coupled with the large-scale inspection load, puts strain on the inspection teams under state drug controllers.

Way forward

  • Regulatory Reforms: Amend the Drugs and Cosmetics Act (1940) and establish a centralized drugs database for effective surveillance. Consolidate regional regulators into a single regulatory body to minimize state-level patronage and influence networks. Implement common standards across states.
  • Enhanced Transparency and Reporting: Publish comprehensive reports on drug testing laboratories’ findings and establish a public database of past violations, inspection records, and failure history. Introduce a national law on drug recall, empowering victims and imposing penalties on firms exporting spurious drugs.
  • Strengthening the Central Drugs Standard Control Organisation (CDSCO): Provide statutory backing and establish a Central Drugs Authority as an independent body, ensuring effective regulation and enforcement.
  • Industry Accountability: The pharmaceutical industry should focus on producing quality generic and innovative drugs, moving beyond generic manufacturing. Embrace zero-defect principles and prioritize public health.


  • Addressing the challenges India’s pharmaceutical industry requires comprehensive reforms, including regulatory consolidation, transparency, enhanced inspections, and industry accountability. By prioritizing patient safety and ensuring the delivery of quality medicines, India’s pharmaceutical industry can reclaim its position as a global leader in drug manufacturing.

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Also read:

India’s delayed implementation of mandatory Drug Recall Law


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

India’s delayed implementation of mandatory Drug Recall Law


From UPSC perspective, the following things are important :

Prelims level : Drug Recalls

Mains level : Read the attached story

Central Idea

  • Abbot published a public notice in newspapers, alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market.
  • Such recalls take place regularly in the US but it is uncommon in India for domestic or foreign pharmaceutical companies to recall substandard or mislabelled drugs.

Recall of Medicines: India story

India has been mulling the creation of a mandatory recall law for substandard drugs since 1976.

  • Drugs Consultative Committee (DCC) meeting in 1976: Resolved to have greater cooperation between state drug controllers to recall and destroy drugs that failed tests.
  • DCC meetings in 1989, 1996, 1998, 2004, 2007, and 2011: Issue of recalls came up but resulted in no amendments to the Drugs & Cosmetics Act.
  • CDSCO proposes draft recall guidelines in 2012: National regulator lacks power to convert guidelines into binding law
  • DCC and Drugs Technical Advisory Board meetings in 2016 and 2018-2019: Issue of recalls resurfaces but India still lacks a recall law, 46 years on.

Why there is no concrete law in India?

  • Complex drug regulatory issues: The Drug Regulation Section of the Union health ministry is not equipped to tackle complex drug regulatory issues.
  • Multiple agencies: India has highly fragmented regulatory structure, with each state having its own drug regulator.
  • Exposing the loopholes: India’s drug regulators are aware that a mandatory drug recall system, will bring to public attention the poor state of affairs in India’s pharmaceutical industry.
  • Evading accountability: The delay in implementing a recall law exposes the lack of accountability and interest in protecting public health.

Consequences of delay

  • Drug failure hazard: Dozens of drugs fail random testing in government laboratories every month.
  • Substandard quality: The lack of a mandatory recall law means substandard drugs, even those with dangerous consequences for consumers, can circulate in the market.
  • Public health crisis: People, including children, are likely dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.

Reasons behind

The lack of a mandatory recall law in India can be attributed to various factors, including-

  1. Lack of expertise
  2. Apathy
  3. Vested interests in enabling the growth of the pharmaceutical industry.

Way forward

  • Implementation of a mandatory drug recall law: The Indian government can take steps to implement a mandatory drug recall law. This law should have teeth to hold pharmaceutical companies accountable for their products.
  • Centralization of regulatory powers: To create an effective recall mechanism, the responsibility of recalling drugs has to be centralized, with one authority that has the legal power to hold companies liable for failures to recall drugs from across the country, and further, to also search and seize batches of failed medicine.
  • Streamlining of regulatory processes: The Indian government can take steps to streamline regulatory processes to reduce the time taken for approvals and ensure that drugs are tested thoroughly before they enter the market.
  • Capacity building of regulatory bodies: The Drug Regulation Section of the Union health ministry should be equipped with the necessary resources, expertise and mandate to tackle complex drug regulatory issues.
  • Encouragement of ethical pharmaceutical companies: The Indian government can encourage ethical pharmaceutical companies by providing incentives to companies that comply with regulatory standards, penalizing those that do not, and promoting transparency in drug pricing.


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

Psychedelics and its uses to treat Depression


From UPSC perspective, the following things are important :

Prelims level : Psychedelics

Mains level : Medicianal use of psychotropic substances

Central idea: The context of the article is about the use of psychedelic drugs for both recreational and medicinal purposes.

What are Psychedelics?

  • Psychedelics are a class of drugs that alter an individual’s perception, mood, and thought processing while still allowing the individual to remain conscious and with unimpaired insight.
  • They are non-addictive and non-toxic, and cause less harm to the end user compared to illicit drugs.
  • The two most commonly used psychedelics are LSD (Lysergic acid diethylamide) and psilocybin. Researchers have also developed synthetic psychedelics.
  • In India, the Narcotic Drugs and Psychotropic Substances Act 1985 prohibits the use of psychedelic substances, except for ketamine which is used under strict medical supervision.

History of psychedelics

  • Humans have used psilocybin and mescaline for ceremonial, healing, and spiritual rituals for millennia.
  • The modern-day use of psychedelics is commonly associated with the German chemist Arthur Heffter isolating mescaline from the peyote cactus in 1897.
  • In 1938, Swiss chemist Albert Hofmann first synthesized LSD while investigating compounds related to ergotamine.
  • LSD was widely used as a therapeutic catalyst in psychotherapy between 1947 and 1967, until it was criminalized in the US due to medical concerns and the Vietnam War.

Experience of using psychedelic substances

  • Users of psychedelic substances report changes in perception, somatic experience, mood, thought-processing, and entheogenic experiences.
  • Perceptual distortions most commonly include the visual domain.
  • Somatic experiences may include the visceral, tactile, and interoceptive domains.
  • Mood changes may include elation, euphoria, anxiety, and paranoia.
  • Entheogenic experiences include transcendental and ineffable spiritual experiences.

How do they work inside the body?

  • Classical psychedelics boost brain serotonin levels.
  • Psilocybin’s therapeutic effects require a ‘trip’ that is mediated by the activation of serotonin receptors.
  • Modern neuroimaging suggests that psychedelics increase the cross-talk between different brain networks, and this correlates with the subjective effects of psychedelics.

Can psychedelic substances cause any harm?

  • Death due to direct toxicity of LSD, psilocybin, or mescaline has not been reported in the literature despite 50-plus years of recreational use.
  • Synthetic psychedelics have been associated with acute cardiac, central nervous system, and limb ischemia, as well as serotonin syndrome.

What is Psychedelic-Assisted Psychotherapy?

  • Psychedelic-assisted psychotherapy has three types of sessions: preparatory, medication, and integration.
  • In the medication session, the patient is accompanied by a male-female co-therapist dyad and a psychedelic drug is administered in a comfortable and well-appointed room.
  • Over the next 6-8 hours, the therapists listen to the patient while maintaining a neutral therapeutic stance.
  • In the integration session, the therapists work with the patient to interpret the contents of their psychedelic experience into meaningful long-term change, based on their thoughts and ideas.

Uses to treat Neuropsychiatric Disorders

  • Research has shown that psychedelic substances have potential therapeutic benefits in treating neuropsychiatric disorders such as treatment-resistant depression and post-traumatic stress disorder (PTSD).
  • In recent trials, a single dose of psilocybin or MDMA-assisted therapy has been shown to reduce depression scores and improve symptoms of PTSD in participants.

Back2Basics: Narcotic Drugs and Psychotropic Substances Act, 1985

Purpose Combat drug abuse and trafficking in India
Scope Consolidates and amends the existing legal framework related to narcotics and psychotropic substances
Regulations Strictly regulates and controls the production, manufacture, sale, transport, possession, and consumption of narcotic drugs and psychotropic substances
Special Courts Establishment of special courts and appointment of special public prosecutors to handle cases related to drug trafficking and abuse
Covered Substances Opium, heroin, cannabis, cocaine, synthetic drugs such as LSD and ecstasy
Classification Substances classified into different schedules based on their potential for abuse and medical use
Punishment Imposes different levels of punishment for offenses related to each schedule
Enforcement Narcotics Control Bureau (NCB), Central Bureau of Narcotics (CBN), and state-level drug enforcement agencies
Functions Prevention of drug abuse and trafficking, investigation and prosecution of drug offenses, rehabilitation and treatment of drug addicts



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

Prices of Essential Medicines set to hike


From UPSC perspective, the following things are important :

Prelims level : Essential Medicines

Mains level : Read the attached story


Prices of 384 essential drugs and over 1,000 formulations are set to see a hike of over 11%, due to a sharp rise in the Wholesale Price Index (WPI).

Implications for customers

  • Annual hikes in the prices of drugs listed in the National List of Essential Medicines (NLEM) are based on the WPI.
  • The price surge will mean that consumers have to pay more for routine and essential drugs, including painkillers, anti-infection drugs, cardiac drugs, and antibiotics.

What are Essential Medicines?

  • As per the World Health Organisation (WHO), Essential Medicines are those that satisfy the priority healthcare needs of the population.
  • Ministry of Health and Family Welfare hence prepared and released the first National List of Essential Medicines (NLEM) of India in 1996 consisting of 279 medicines.
  • The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines.
  • Such medicines are intended to be available in adequate amounts, in appropriate dosage forms and strengths with assured quality.
  • They should be available in such a way that an individual or community can afford.

NLEM in India

  • Drugs listed under NLEM — also known as scheduled drugs — will be cheaper because the National Pharmaceutical Pricing Authority (NPPA) caps medicine prices and changes only based on wholesale price index-based inflation.
  • The list includes anti-infectives medicines to treat diabetes such as insulin — HIV, tuberculosis, cancer, contraceptives, hormonal medicines and anaesthetics.
  • They account for 17-18 per cent of the estimated Rs 1.6-trillion domestic pharmaceutical market.
  • Companies selling non-scheduled drugs can hike prices by up to 10 per cent every year.
  • Typically, once NLEM is released, the department of pharmaceuticals under the ministry of chemicals and fertilisers adds them in the Drug Price Control Order, after which NPPA fixes the price.

Who regulates Drugs prices?

  • The NPPA was set up in 1997 to fix/revise prices of controlled bulk drugs and formulations and to enforce price and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995-2013.
  • Its mandate is:
  1. To implement and enforce the provisions of the DPCO in accordance with the powers delegated to it
  2. To deal with all legal matters arising out of the decisions of the NPPA
  3. To monitor the availability of drugs, identify shortages and to take remedial steps
  • The NPPA is also mandated to collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc., for bulk drugs and formulations and undertake and/ or sponsor relevant studies in respect of pricing of drugs/ pharmaceuticals.

How does the pricing mechanism work?

  • Prices of Scheduled Drugs are allowed an increase each year by the drug regulator in line with the Wholesale Price Index (WPI) and the annual change is controlled and rarely crosses 5%.
  • But the pharmaceutical players pointed out that over the past few years, input costs have flared up.
  • The hike has been a long-standing demand by the pharma industry lobby.
  • All medicines under the NLEM are under price regulation.


Try this MCQ

Q. Which of the following is not a mandate of the National Pharmaceutical Pricing Authority (NPPA)?

A) Fixing and revising prices of controlled bulk drugs and formulations

B) Enforcing price and availability of medicines in the country

C) Monitoring the availability of drugs and taking remedial steps

D) Regulating the import and export of pharmaceutical products


Post your answers here.
Please leave a feedback on thisx

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

Contamination of medicine: India; The Pharmacy of the world needs a relook in drug regulations


From UPSC perspective, the following things are important :

Prelims level : NA

Mains level : Contamination of medicines and drug regulations in India



  • Merely two months after the World Health Organisation (WHO) sounded an alert over deadly contamination in four brands of cough syrup manufactured by a Sonepat-based pharmaceutical company that were subsequently linked to the deaths of 72 children in Gambia, another Indian pharmaceutical company stands accused of a similar crime. This time, it is Uzbekistan which has accused a Noida-based pharmaceutical company of selling contaminated cough syrup that has allegedly killed 18 children in that country.

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Thorough analysis

  • Unacceptable levels of Ethylene/ Diethylene glycol: In both cases, lab tests reportedly found unacceptable levels of diethylene glycol (DEG) or ethylene glycol (EG) or both in the cough syrups.
  • Ideally these chemicals should not be found in any medicine: Both DEG and EG are deadly chemicals that should not be found in any medicine.
  • Then how these chemicals end up in medicines: The typical reason these chemicals end up in medicine is because pharmaceutical manufacturers do not adequately test industrial solvents purchased from chemical traders and used to manufacture cough syrups despite the fact that the law mandates such testing for contamination.
  • Proximity in two cases: Given the physical proximity of the manufacturers implicated in the Gambian and Uzbekistan cases, there is a very high possibility that the same batch of contaminated industrial solvent was used by both companies.


Contamination of medicines in India

  • India has a tumultuous history of DEG contamination in medicines: Between 1972 and 2020, India has seen at least five mass DEG poisonings in Chennai, Mumbai, Bihar, Gurgaon and Jammu. The incident in Gurgaon led to the death of 33 children and the incident in Jammu of at least 11 children.
  • Difficult to diagnose deaths due to adulterated medicine: The final reported toll in such cases is definitely an undercount because it is notoriously difficult for doctors to diagnose such deaths and attribute them to adulterated medicine.
  • Lethargy and denial is a pattern with drug regulators in India: In August 2020, about eight months after the DEG-related deaths of the children in Jammu were first reported by PGIMER, Chandigarh, the same hospital reported that another two-year-old child from Baddi had died in its facility after consuming a different brand of cough syrup manufactured by the same company that was responsible for the deaths earlier in Jammu. This was a death that could have been easily avoided if the regulators had conducted and published a thorough root cause analysis after the Jammu incident and followed it up by a nationwide recall of all cough syrups manufactured at the same facility. This never happened.


Critique: Whether the Ministry of Health and the Central Drugs Standard Control Organization have learnt their lessons from these previous incidents?

  • Government will handle the issue just as any other public relation crisis: The present government is likely to handle this crisis as yet another public relations crisis instead of a public health crisis. Assumption is based on the observation of the official response from the government to the tragedy in Gambia.
  • Instead of condoling, accused them for not testing before prescribing: Far from condoling the deaths of 72 Gambians, the initial press release from the Ministry of Health gaslit the Gambians by accusing them of not testing the cough syrups before prescribing them to patients.
  • False presumption that the drug regulator is doing its job well: This was an absurd allegation because nobody tests drugs that are purchased before releasing them for patient use, even in India. The presumption is that the drug regulator is doing its job to ensure quality control.
  • Government’s information czars accusing WHO: The first step of this PR strategy was to keep leaking to journalists that the WHO was not co-operating with the information requests made by an expert committee set up by the Government of India to investigate the deaths in Gambia. This despite the government fully knowing that the responsibility of investigating the deaths lay not with the WHO but with the sovereign authorities in Gambia.
  • Rare mention of sympathy: The common thread running through these events is a communications strategy aimed at denial and intimidation. There is rarely a mention of sympathy for lives lost or a commitment to protect public health.
  • Even China does better than India: An iron fist in a titanium glove is the best way to describe the government’s response to any allegations of quality issues afflicting the Indian pharmaceutical industry. In 2007, when a Chinese chemicals manufacturer was implicated in the deaths of 365 people in Panama who consumed cough syrup manufactured with an adulterated industrial solvent, the Chinese arrested the manufacturer and publicly promised to punish him.


What should be done immediately?

  • The immediate public health response in these cases of DEG contamination should be aimed at limiting further deaths.
  • This means tracing the origins of the contaminated industrial solvent used to manufacture the syrups.


  • What India needs right at the moment is to accept the fact that there is a major quality problem with the Indian pharmaceutical industry. Allegations cannot be morphed from one to another. Perhaps the need of the hour is to have meaningful and comprehensive conversation on actual regulatory reform.

Mains question

Q. It is said that India has a tumultuous history of DEG contamination in medicines. The recent deaths in Gambia and Uzbekistan supports this statement. What the critique has to say over India’s response in such cases.

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

Indian biotech investigated following deaths of Uzbek children


From UPSC perspective, the following things are important :

Prelims level : NA

Mains level : Challenges to Indian pharma sector

The Central Drugs Standards Control Organisation (CDSCO) are investigating Noida-based firm after the deaths of 18 children in Uzbekistan by drinking health syrup contaminated with Diethylene Glycol (DEG).

India’s response to these deaths

  • It is certainly the responsibility of the importing country to test medicines before releasing them in their market.
  • After being informed about the incident, India’s apex regulatory body, Central Drugs Standard Control Organisation (CDSCO) opened investigations and lifted control samples.

Issue: India’s credibility at stake

  • India is one of the leading exporters of medicines.
  • PM Modi recently stressed that Indian drugs had earned the world’s trust and that India could be called the ‘pharmacy to the world’.
  • However, such negative reports on the quality and safety of our medicines will be a massive blow to the country’s image as a source of cheap generic drugs to the world.

Issues highlighted by the incident

  • Smuggling of cheap drugs: Inquiry reveals that these were imported from an Indian manufacturer, not under public tender but privately.
  • Ignorance by authorities: The drug which is banned for domestic consumption has got exported and led to fatalities. This is a huge blissful mistake by Indian Authorities.
  • Lack of inspection: There are not enough drug inspectors in the country to conduct as many inspections as is ideally required in such as vast set-up.
  • Inadequacies in quality-check: Despite huge production units, there are not an adequate number of laboratories to test the samples in time if all the samples that should be lifted for testing are picked up.
  • Blot on credibility: The matter, if not properly handled, can damage the perception that Indian medicines are trustworthy for many countries and the global South.

Possible factors behind this tragedy

  • There are rackets of counterfeit Indian medicines turning up in many countries.
  • Some of these were coming from unregistered producers in India, who would produce medicine depending on what cost was paid to them without concern for quality.
  • In some cases, competitors from other countries were known to make counterfeit medicines with Indian markings and dump them in markets where Indian pharmaceuticals were well regarded.

Way forward

  • The pharmaceutical trade is vital and must be protected from predatory practices and violations of regulatory norms.
  • Regulatory mechanism on both sides should be strengthened.
  • Importers should be given lists of recognised Indian manufacturers.
  • Training should be provided to drug controllers to curtail the menace of counterfeit and poor-quality medicine entering from India.

Back2Basics: Diethylene Glycol (DEG)

  • A/c to WHO, Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal.
  • It can cause kidney and neurological toxicity and has been associated with several cases of mass poisoning when consumed via drugs.
  • The chemical tastes sweet and is water-insoluble.
  • The toxic effects of the chemical include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury.


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

Role of private sector in India’s Space programmes


From UPSC perspective, the following things are important :

Prelims level : Private space programs

Mains level : Indian private sector participation in space programmes.


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  • The launch of the Vikram S (Mission Prarambh) rocket last week has been rightly hailed as an important milestone in India’s outer space journey. It is the first privately built Indian rocket to make it to space.

Private players in space sector

  • Lack of Enabling policy: The country’s private sector has the talent and experience to shorten that distance if Delhi creates the enabling policy environment.
  • Monopoly of Government: When space emerged as an important endeavour in the second half of the 20th century, governments were in the lead. The cost, complexity and research-intensity of the space effort meant the space programmes everywhere became a government monopoly.
  • Government can no longer ignore private players: But in the 21st century, the role of the private sector has dramatically expanded. Satellites were once owned only by governments but today private companies lead the satellite business.


Major private players and their space endeavor

  • Starlink satellite system: Elon Musk’s Starlink satellite system is now a major player with more than 2,300 satellites in low earth orbit they deliver a variety of space services including useful military information to the armed forces of Ukraine in their fight against Russian forces.
  • Amazon’s Project Kuiper: Plans to launch more than 3,000 satellites in the coming years to offer a range of services, including broadband internet. This will involve making at least three satellites a day.
  • One-web cooperation: Airtel in India is a partner in the One-Web corporation that offers connectivity through its system of nearly 500 satellites.
  • Breaking the monopoly of Government: The business of launch vehicles the most demanding of space activities remained a state monopoly until recently. Elon Musk’s SpaceX has broken through that launch monopoly and Amazon’s Blue Origin rocket will soon be in the market too.

History of India’s space programme

  • Space for national development only: Delhi’s main objective was to leverage outer space to accelerate national development. Eventually, military and commercial dimensions began to envelop the Indian space programme.
  • Cooperation with Soviet Union: India’s space programme began with intensive cooperation with the Western countries and later with the Soviet Union. Delhi also offered space cooperation to other developing countries within the rubric of engagement with friendly governments.
  • Sanctions halted India’s progress: The non-proliferation sanctions on India after its first nuclear test in 1974 severely constricted the space for the country in international space cooperation. It was only after the historic civil nuclear initiative that the sanctions regime began to ease.


What should be India’s future approach in space domain?

  • Commercially leveraging the space using MTCR: India is now part of the Missile Technology Control Regime that regulates commerce in space related commodities and technologies.
  • Dual use technology under Wassenaar Arrangement: India is also part of the Wassenaar Arrangement that controls trade in dual use technologies that can be used for both civilian and military purposes.
  • The growing range of new space possibilities: From using satellites for delivering broadband internet to the mining of the Moon and from space manufacturing to deep space exploration. Put simply, the scale of the global economy is rapidly growing its value is expected to more than double from about $450 billion in 2022 to nearly one trillion dollars within a decade.
  • It must be about business and economy: For India, outer space can no longer be about narrowly framed ideas of “development” and “national prestige”. It must be about business and economy. The current Indian share of the global space economy is barely 2 per cent. PM Modi has been demanding that India rapidly increase its share to 8 per cent in the coming years.
  • The private sector companies for larger role: Raising the Indian share of the global space economy can only be done by drawing in the private sector companies to play a larger role. Consider, for example, The Artemis 1 rocket was launched last week and the programme involves a number of leading aerospace companies like Boeing, Lockheed, Northrop Grumman, Airbus and Space X.
  • International cooperation in national space programmes: If Apollo was a purely national project of the United States, the Artemis programme is a multinational endeavor between the US and its partners, including France, Canada, and Japan. Meanwhile Russia and China are coming together to collaborate not only on their space programmes, but also on building a joint base on the Moon that will establish long term human presence there.
  • Capital support for space programme: India has just about embarked on a programme to enhance the contribution of its private sector in outer space. India is also drawing on foreign capital to support its start-ups. Singapore’s sovereign wealth fund GIC, for example, is a major investor in Skyroot Aerospace that launched the Vikram S rocket.


  • Many Western aerospace companies will be eager to invest in India’s space programme as it begins to open up. India is also coming to terms with the fact that international cooperation is not just an “add-on” to the national space programme, but must be an integral part of India’s space strategy.

Mains Question

Q. 20th century was dominated by monopoly of government in space domain. Elaborate. How India can commercialize the space sector with help of private players?

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

What is National List of Essential Medicines (NLEM)?


From UPSC perspective, the following things are important :

Prelims level : Essential Medicines

Mains level : Not Much

The latest National List of Essential Medicines (NLEM) released September 13, 2022 by the Union health ministry added 34 new medicines and dropped 26 old ones from the previous list.

What is NLEM?

  • As per the World Health Organisation (WHO), Essential Medicines are those that satisfy the priority health care needs of the population.
  • Ministry of Health and Family Welfare hence prepared and released the first National List of Essential Medicines of India in 1996 consisting of 279 medicines.
  • The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines.
  • Such medicines are intended to be available in adequate amounts, in appropriate dosage forms and strengths with assured quality.
  • They should be available in such a way that an individual or community can afford.

NLEM in India

  • Drugs listed under NLEM — also known as scheduled drugs — will be cheaper because the National Pharmaceutical Pricing Authority (NPPA) caps medicine prices and changes only based on wholesale price index-based inflation.
  • The list includes anti-infectives medicines to treat diabetes such as insulin — HIV, tuberculosis, cancer, contraceptives, hormonal medicines and anaesthetics.
  • They account for 17-18 per cent of the estimated Rs 1.6-trillion domestic pharmaceutical market.
  • Companies selling non-scheduled drugs can hike prices by up to 10 per cent every year.
  • Typically, once NLEM is released, the department of pharmaceuticals under the ministry of chemicals and fertilisers adds them in the Drug Price Control Order, after which NPPA fixes the price.

Significance of EML

  • Drawing an essential medicines list (EML) is expected to result in better quality of medical care, better management of medicines and cost-effective use of health care resources.
  • This is especially important for a resource limited country like India.
  • The list of essential medicines is intended to have a positive impact on the availability and rational use of medicines.

Also read

What is the NPPA’s role in fixing drug prices?


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

When pharma companies cross red lines


From UPSC perspective, the following things are important :

Prelims level : NA

Mains level : Pharma sector malpractices in India

pharma companiesMarketing practices of pharma companies are under scrutiny after tax officials searched the premises of a drugmaker, and an association of medical representatives moved the Supreme Court alleging unethical marketing practices by drugmakers.

paharma companiesThe Dolo controversy

  • Bengaluru-based pharmaceuticals company Micro Labs Ltd came under the spotlight recently over the promotion of its anti-fever drug Dolo 650, which was widely used during the covid-19 pandemic.
  • Surprisingly, this drug which contained paracetamol was widely endorsed by doctors all across the India.
  • The Supreme Court last week ordered the central government to respond to a petition filed on the issue of unethical marketing practices by drug makers.
  • The Income Tax department too has accused it of claiming unallowable expenses made on freebies meant to boost sales.

How do drugmakers incentivize doctors?

  • While many medical professionals claim that financial incentives do not influence their practice, some say that private sector doctors are enticed by pharmaceutical companies’ marketing agents to promote their drugs.
  • Pharma companies’ sales executives visit doctors to brief them about new drugs or a new drug component.
  • They try to impress upon them to prescribe their brands and in return, doctors are offered some gifts name reminders such as pens, writing pads, books and sometimes expensive gifts and holidays.
  • Such benefits extended to doctors depend upon the kind of drug, the disease burden etc.

pharma companiesIs this a widespread industry practice?

  • A government doctor said no pharma firm can sustain without marketing its drug.
  • It mostly happens when there is an outbreak, or if there is great demand for a particular drug or when a drug is being launched.
  • Unlike in the case of other products, the decision to buy a drug is not made by the consumer, but by the doctor.
  • This makes pharma a marketing-driven industry.

Are hospitals incentivized too?

  • Yes; doctors at a top private hospital which treated a large number of covid-19 patients said drug giants do try to incentivize hospitals.
  • The possibilities increase when a large corporate hospital chain operating across the country buys a drug in bulk.
  • A doctor at a corporate hospital does not have any control over the drugs sold in the in-house pharmacy of the hospital.
  • Doctors running small clinics see limited patients, and they do not have pharmacies; so, the issue of incentivization does not arise.

What does the I-T dept find wrong in this?

  • While pharma companies treat freebies as a marketing expense which is deducted while computing their taxable income, getting the beneficiary of this spending to report it as his income has been a challenge.
  • In some cases, tax officials have denied promotional expenses as a deduction.
  • Hence, the government introduced a 10% tax to be deducted at source (TDS) effective 1 July, so that doctors and social media influencers report such benefits in their tax returns and pay tax on what it is worth.


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

Drugs, Medical Devices and Cosmetics Bill 2022


From UPSC perspective, the following things are important :

Prelims level : Schedule H drugs

Mains level : Paper 3- E-commerce for medical drug


A draft law to replace the 1940 Drugs and Cosmetics Act with a Drugs, Medical Devices and Cosmetics Bill 2022 was uploaded by the Union health ministry in early July, seeking public comments and objections.

Major provisions of the Bill

 1] E-commerce for medical drugs

  • Presently, online sales of medicines account for a fraction of the total pharma sales in India but are forecast to grow exponentially.
  • The first major feature in the new Bill that affects consumers relates to e-commerce.
  • Like all online shopping, the consumer gets the advantage of discounts and the comfort of shopping from home.
  • In normal times, e-commerce can surmount three uniquely Indian disadvantages.
  • Storage condition: The first relates to climatic conditions, which require medicines to be stored at below 30 degrees Celsius and 70 per cent relative humidity — unattainable in most of India.
  •  It can mandate establishing a back-end brick and mortar store for drug supply having good storage conditions.
  • Compliance with regal provision: The second advantage of e-commerce could be fulfilling a legal requirement — providing a bill to the consumer and retaining one copy bearing the batch numbers and expiry dates of the drugs.
  • In addition, the practice of accessing prescription drugs over-the-counter would reduce.
  • In the case of e-commerce, registration of a pharmacy can require enrollment with the central and state drug control organisations and the practice of uploading a prescription from a registered medical practitioner can be enforced.
  • Concern: Shopping for medical drugs on the internet could encourage overuse or incomplete use of drugs, increase dependency on habit-forming medicine — for example, sleep-inducing drugs or self-medication with products for weight loss, male enhancement, even treating mental illness — which is fraught with dangerous consequences.
  •  A greater focus on medical devices: The draft law also proposes according a greater focus on medical devices, which include thousands of engineered apparatuses like stents, joint implants, pacemakers, catheters, etc, which require quality regulation.
  • Provision for advisory board: Rules for medical devices were notified in 2017 but now it is proposed to establish a statutory Medical Device Technical Advisory Board, with experts from the fields of atomic energy, science and technology, electronics, and related fields like biomedical technology to guide the process.
  • This is a welcome move that will bring in the required expertise.

Issues not addressed in the Bill

  • Mismanagement of trade: What the Bill does not address is the need to stop the continued mismanagement of the wholesale and retail drugs trade in India.
  • Requirements for drug license not changed: Rule 64 (2) of the Drugs and Cosmetics Rules 1945 lays down that a wholesale drug licence can be given to a qualified pharmacist or one who has passed the matriculation examination or its equivalent or a graduate with one year’s experience in dealing with drug sale.
  • This is a relic from 80 years ago.
  • When the country is reported to have over 7,00,000 pharmacists, this anachronism must be discarded.
  •  It is essential to introduce a binding and enabling provision to only licence qualified pharmacists and put the safety of millions of citizens before the self-preservation of a few thousand wholesalers and stockists.

Way forward

  • There is need for ensuring digitisation of procurement, inventory control and accountability for dispensing drugs into a digital trail.


The debate should not be between e-commerce and retail sale. It should be between being compliant and non-compliant.

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

What is the NPPA’s role in fixing drug prices?


From UPSC perspective, the following things are important :

Prelims level : NPPA

Mains level : Drugs price regulation

Consumers may have to pay more for medicines and medical devices if the National Pharmaceutical Pricing Authority (NPPA) allows a price hike of over 10% in the drugs and devices listed under the National List of Essential Medicines (NLEM), this coming month.

Who regulates Drugs prices?

  • The NPPA was set up in 1997 to fix/revise prices of controlled bulk drugs and formulations and to enforce price and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995-2013.
  • Its mandate is:
  1. To implement and enforce the provisions of the DPCO in accordance with the powers delegated to it
  2. To deal with all legal matters arising out of the decisions of the NPPA
  3. To monitor the availability of drugs, identify shortages and to take remedial steps
  • The NPPA is also mandated to collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc., for bulk drugs and formulations and undertake and/ or sponsor relevant studies in respect of pricing of drugs/ pharmaceuticals.

How does the pricing mechanism work?

  • Prices of Scheduled Drugs are allowed an increase each year by the drug regulator in line with the Wholesale Price Index (WPI) and the annual change is controlled and rarely crosses 5%.
  • But the pharmaceutical players pointed out that over the past few years, input costs have flared up.
  • The hike has been a long-standing demand by the pharma industry lobby.
  • All medicines under the NLEM are under price regulation.

Do you know?

As per the Drugs (Prices) Control Order 2013, scheduled drugs, about 15% of the pharma market, are allowed an increase by the government as per the WPI while the rest 85% are allowed an automatic increase of 10% every year.

How are the prices determined?

  • The ceiling price of a scheduled drug is determined by first working out the simple average of price to retailer in respect of all branded and generic versions of that particular drug formulation.
  • It should have a market share of more than or equal to 1%, and then adding a notional retailer margin of 16% to it.
  • The ceiling price fixed/revised by the NPPA is notified in the Gazette of India (Extraordinary) from time to time.

When are the prices revised?

  • Prices are revised when there is a rise in the price of bulk drugs, raw materials, cost of transport, freight rates, utilities like fuel, power, diesel, and changes in taxes and duties.
  • The cost rises for imported medicines with escalation in insurance and freight prices, and depreciation of the rupee.
  • The annual hike in the prices of drugs listed in the NLEM is based on the WPI.
  • The NLEM lists drugs used to treat fever, infection, heart disease, hypertension, anaemia etc and includes commonly used medicines like paracetamol, azithromycin etc.

Why are inputs costs high?

  • One of the challenges is that 60%-70% of the country’s medicine needs are dependent on China.
  • WPI is dependent on price rise in a basket of a range of goods that are not directly linked with the items that go into the cost of medicines.


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

Draft National Policy for Medical Devices, 2022


From UPSC perspective, the following things are important :

Prelims level : Not much

Mains level : National Policy for Medical Devices, 2022

The government is proposing a new Draft National Policy for Medical Devices, 2022 to reduce India’s dependence on import of high-end medical devices.

Key features of the policy

Objectives: Adopting public-private partnerships to reduce the cost of healthcare, drive efficiency, and aid quality improvements in medical devices manufactured in the country

The key proposals include:

  1. Incentivising the export of medical devices and related technology projects through tax rebates and refunds
  2. Increasing government spending in “high-risk” projects in the medical devices sector
  3. Single-window clearance system for licencing medical devices
  4. Pricing environment with no price control on newly developed innovation in the sector
  5. Allot a dedicated fund for encouraging joint research involving existing industry players, reputed academic institutions and start-ups
  6. Incorporate a framework for a coherent pricing regulation, to make available quality and effective medical devices to all citizens at affordable prices
  7. NPPA (National Pharmaceutical Pricing Authority) shall be strengthened with adequate manpower of suitable expertise to provide effective price regulation balancing patient and industry needs.
  8. Pharmaceuticals Department will also work with industry to implement a Uniform Code for Medical Device Marketing Practices (UCMDMP)

Need for such policy

  • Policy vacuum: India’s medical devices sector has so far been regulated as per provisions under the Drugs and Cosmetics Act of 1940, and a specific policy on medical devices has been a long standing demand from the industry.
  • Meaningful expense on R&D: The policy also aims to increase India’s per capita spend on medical devices. India has one of the lowest per capita spend on medical devices at $3, compared to the global average of per capita consumption of $47.
  • Reducing import dependence: With the new policy, the government aims to reduce India’s import dependence from 80 per cent to nearly 30 per cent in the next 10 years.
  • Becoming a global hub: It aims to become one of the top five global manufacturing hubs for medical devices by 2047.
  • Domestic manufacturing of high-end products: Indian players in the space have so far typically focussed on low-cost and low-tech products, like consumables and disposables, leading to a higher value share going to foreign companies.

Earlier attempts for such policy

  • In February 2020, the government notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940.
  • This was necessitated after revelations about faulty hip implants marketed by Johnson & Johnson, exposing the lack of regulatory teeth when it came to medical devices.
  • The government said the transition from partial regulation of selected medical services to the complete regulation and licensing of all medical devices is underway.


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

Global Drug Policy Index inaugurated


From UPSC perspective, the following things are important :

Prelims level : Global Drug Policy Index

Mains level : Not Much

The first-ever Global Drug Policy Index was recently inaugurated.

Global Drug Policy Index

  • It is released by the Harm Reduction Consortium, ranks Norway, New Zealand, Portugal, the UK and Australia as the five leading countries on humane and health-driven drug policies.
  • It is a data-driven global analysis of drug policies and their implementation.
  • It is composed of 75 indicators running across five broad dimensions of drug policy:
  1. Criminal justice
  2. Extreme responses
  3. Health and harm reduction
  4. Access to internationally controlled medicines and
  5. Development

Highlights of the 2021 ranking

  • The five lowest-ranking countries are Brazil, Uganda, Indonesia, Kenya, and Mexico.
  • Norway, despite topping the Index, only managed a score of 74/100.
  • And the median score across all 30 countries and dimensions is just 48/100.

India’s performance

  • India’s rank is 18 out of 30 countries
  • It has an overall score of 46/100.


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

Section 27A of the NDPS Act


From UPSC perspective, the following things are important :

Prelims level : Not much

Mains level : NDPS Act

Last week, the Tripura High Court, in a significant verdict, discovered an oversight in drafting the 2014 amendments to the Narcotics Drugs and Psychotropic Substances Act, 1985.

What is Section 27A?

  • The NDPS had unintentionally rendered a key provision of the Act, Section 27A which provides for punishment of those financing illicit trafficking, inoperable.
  • This section has been consistently evoked since a year after the alleged suicide of a notable Bollywood actor after drugs intoxication.

What is the provision?

  • The NDPS Act, 1985 is the principal legislation through which the state regulates the operations of narcotic drugs and psychotropic substances.
  • It provides a stringent framework for punishing offenses related to illicit traffic in narcotic drugs and psychotropic substances through imprisonments and forfeiture of property.
  • Section 27A of the NDPS Act, 1985, prescribes the punishment for financing illicit traffic and harboring offenders.
  • The court may, for reasons to be recorded in the judgment, impose a fine exceeding two lakh rupees.”

So why is this provision inoperable?

  • The text of the provision says that offences mentioned under Section 2(viiia) sub-clauses i-v are punishable through Section 27A.
  • However, Section 2 (viiia) sub-clauses i-v, which is supposed to be the catalog of offences, does not exist after the 2014 amendment.
  • So, if Section 27A penalises a blank list or a non-existent provision, it can be argued that it is virtually inoperable.

What was the 2014 amendment?

  • In 2014, a key amendment was made to the NDPS Act to allow for better medical access to narcotic drugs.
  • Since the regulation under NDPS was very stringent, despite being a leading manufacturer of morphine, an opioid analgesic used as a painkiller, it was difficult to access the drug even for hospitals.

Exceptions for essential drugs

  • The 2014 amendment essentially removed state-barriers in transporting, licensing drugs classified as “essential narcotic drugs”, and made it centralized.
  • This was done by first introducing a provision in Section 2 that defines essential narcotic drugs, and subsequently in Section 9 allowing the manufacture, possession, transport, import inter-State, export inter-State, sale, purchase, consumption and use of essential narcotic drugs.
  • The amendment to add the definition of essential narcotic drugs re-lettered the old Section 2(viii)a that was the catalog of offences as Section 2(viii)b, and under the Section 2(viii)a, defined essential narcotic drugs.
  • However, the drafters missed amending the enabling provision in Section 27A to change Section 2(viii)a to Section 2(viii)b.

How was this error noticed?

  • In 2016, an accused sought bail before a special judge in West Tripura in Agartala citing this omission in drafting.
  • The accused’s plea was that since Section 27A penalized a blank list, he could not be charged under the offence.
  • The district judge then referred the case to the Tripura High Court.

What did the HC decide?

  • The Law Ministry had argued that the court must overlook the omission and read the legislation as a whole. It also told the court that the provision would be amended to rectify the dissonance.
  • The Tripura HC agreed with the government’s view, but said that it may not be the best solution.
  • The amendment is yet to take place. However, criminal laws cannot be amended retrospectively.
  • Article 20 of the Constitution guarantees protection against double jeopardy.
  • So even if the amendment is brought in, the result of the drafting error could lead to more constitutional questions being raised.

Back2Basics: Article 20 of the Indian Constitution

The Article 20 is one of the pillars of fundamental rights guaranteed by the Constitution of India. It mainly deals with protection of certain rights in case of conviction for offences.

(1) No person shall be convicted of any offence except for violation of a law in force at the time of the commission of the Act charged as an offence, nor be subjected to a penalty greater than that which might have been inflicted under the law in force at the time of the commission of the offence.

(2) No person shall be prosecuted and punished for the same offence more than once.

(3) No person accused of any offense shall be compelled to be a witness against himself.

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

[pib] Indian Certification of Medical Devices (ICMED) Plus Scheme


From UPSC perspective, the following things are important :

Prelims level :  ICMED 13485 PLUS

Mains level : NA

The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED Scheme for Certification of Medical Devices.


  • The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
  • It was first launched in 2016.
  • It has been designed to integrate the Quality Management System components and product-related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
  • This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
  • This scheme will be an end-to-end quality assurance scheme for the medical devices sector in India.

Details of the scheme

  • This scheme provides the much-needed institutional mechanism for assuring product quality and safety.
  • It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
  • This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.

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

Operation Pangea XIV


From UPSC perspective, the following things are important :

Prelims level : Operation Pangea XIV

Mains level : NA

More than 1.10 lakh web links, including websites and online marketplaces, have been taken down in the operation Pangea XIV.

Operation Pangea XIV

  • Code-named “Operation Pangea XIV”, the exercise was coordinated by Interpol.
  • It involved the police, customs, and health regulatory authorities of 92 countries against the sale of fake and illicit medicines and medical products.
  • Indian agencies also participated in the operation, said an official of the Central Bureau of Investigation that is the nodal body for the Interpol in the country.
  • It showed that criminals were continuing to cash in on the huge demand for personal protection and hygiene products due to the COVID-19 pandemic.

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

What is 2-deoxy-D-glucose (2-DG) and is it effective against Covid?


From UPSC perspective, the following things are important :

Prelims level : 2-DG

Mains level : Paper 3- Drug developed by DRDO approved for Covid treatment

About the drug

  • DRDO’s new anti-Covid oral drug, 2-deoxy-D-glucose (2-DG), was recently granted emergency use approval by the Drug Controller General of India (DCGI).
  •  2-DG halts the spread of COVID-19 inside the body cells.
  • Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
  • In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints.
  • A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC.

How 2-DG reduces dependence on oxygen

  • The 2 DG drug, like glucose, spreads through the body, reaches the virus-infected cells and prevents virus growth by stopping viral synthesis and destroys the protein’s energy production.
  • The drug also works on virus infection spread into lungs which help us to decrease patients dependability on oxygen.


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

Replicating success in space and pharmaceuticals in knowledge economy


From UPSC perspective, the following things are important :

Prelims level : Not much

Mains level : Paper 3- India's success in space technology and pharmaceuticals

The article underlines India’s success in pharma and space, and also analyses the reasons for India’s inability to replicate the success in other areas.

India’s success in space and pharmaceuticals

  • The launch of Brazil’s Amazonia-1 satellite by the Indian Space Research Organisation (ISRO) comes weeks after India allowed the export of COVID-19 vaccine to Brazil.
  • Taken together, these two examples of technological and scientific cooperation draw attention to the diplomatic potential of India’s knowledge economy.
  • The credit for India’s competitive pricing of satellite launches and pharmaceuticals exports goes entirely to Indian engineering, scientific and technological talent.

Decrease in capability for knowledge-based diplomacy

  • Indian science and technology had something to offer the developing world that the developed economies of the West were either unwilling to provide or did so at much higher cost.
  • Overseas students were drawn to Indian universities and institutions because they offered good quality education at a fraction of the cost of developed country institutions.
  • The appeal of education in India for overseas students has waned.
  • Indian expertise was sought by global organisations such as the Food and Agriculture Organisation (FAO), the United Nations Industrial Development Organisation (UNIDO) and International Rice Research Institute (IRRI).
  • Rail India Technical and Economic Services (RITES), had acquired a global profile with business in Africa and Asia.
  • The development of India’s dairy and livestock economy also attracted global interest.

Factors responsible

  • India lost this leadership in the knowledge economy, barring sectors like space, pharma and information-technology, for two reasons.
  • First, a flight of Indian talent that began in the 1970s and has since accelerated. This has sharply increased in recent years.
  • Second, China has emerged as a major competitor offering equally good, if not better quality, S&T products and services at lower cost.

Consider the question “India’s success in pharma and space indicates its potential. What are the challenges India faces in replicating the success in these two sectors in other areas of the economy?


Global success of space and pharma points to the diplomatic potential of the knowledge industry and to India’s “soft power”. However, the fact that they are the exception rather than the rule points to the lack of political and intellectual support to the development of India’s knowledge base and an inadequate commitment to excellence.

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

What is the Emergency Use Authorization (EUA) for Drugmakers?


From UPSC perspective, the following things are important :

Prelims level : Vaccine for COVID

Mains level : Universalization of vaccines and associated challenges in India

The US drugmaker Moderna said it was applying for emergency use authorisation for its vaccine in India.

Practice question for Mains:

Q. What is Vaccine Nationalism? Discuss various ethical issues involved and its impact on vulnerable populations across the globe.

Emergency Use Authorisation (EUA)

  • Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered.
  • In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
  • The approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials.
  • This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
  • The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.

Exceptions for emergency

  • In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals.
  • However, there should sufficient evidence to suggest a medical product is safe and effective.
  • Final approval is granted only after completion of the trials and analysis of full data; until then, EUA allows the medicine or the vaccine to be used on the public.

What is the process of getting a EUA in India?

  • India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
  • Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic — for remdesivir and favipiravir in June, and itolizumab in July.

Associated risks

  • The public has to be informed that a product has only been granted a EUA and not full approval.
  • In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks.

Not a compulsion

  • There has been an ongoing debate over whether people have the option of refusing to take the vaccine.
  • Incidentally, no country has made vaccination compulsory for its people.
  • Initially, all vaccines are likely to be deployed on emergency use authorizations only. Final approval from may take several months, or years.

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

What are Bulk Drugs Parks?


From UPSC perspective, the following things are important :

Prelims level : Bulk Drugs

Mains level : India's pharma sector

Himachal Pradesh is one of the states vying for the allotment of a bulk drug park under a central government scheme announced earlier this year for setting up three such parks across the country.

Try this question:

Q.The drug pricing system in India is an indirect outcome of the growing dependence on China for APIs. Discuss.

What are Bulk Drugs or APIs?

  • A bulk drug also called an active pharmaceutical ingredient (API), is the key ingredient of a drug or medicine, which lends it the desired therapeutic effect or produces the intended pharmacological activity.
  • For example, paracetamol is a bulk drug, which acts against pain.
  • It is mixed with binding agents or solvents to prepare the finished pharmaceutical product, ie a paracetamol tablet, capsule or syrup, which is consumed by the patient.
  • APIs are prepared from multiple reactions involving chemicals and solvents.
  • The primary chemical or the basic raw material which undergoes reactions to form an API is called the key starting material, or KSM.
  • Chemical compounds formed during the intermediate stages during these reactions are called drug intermediates or DIs.

Why is India promoting bulk drug parks?

  • India has one of the largest pharmaceutical industries in the world (third largest by volume) but this industry largely depends on other countries, particularly China, for importing APIs, DIs and KSMs.
  • This year, drug manufacturers in India suffered repeated setbacks due to disruption in imports.
  • Factories in China shut down when the country went into a lockdown, and later, international supply chains were affected as the Covid pandemic gripped the entire world.
  • The border conflict between India and China exacerbated the situation.

What is the Centre’s scheme?

  • The Centre’s scheme will support three selected parks in the country by providing a one-time grant-in-aid for the creation of common infrastructure facilities.
  • The grant-in-aid will be 70 per cent of the cost of the common facilities but in the case of Himachal Pradesh and other hill states, it will be 90 per cent.
  • The Centre will provide a maximum of Rs 1,000 crore per park.
  • A state can only propose one site, which is not less than a thousand acres in area, or not less than 700 acres in the case of hill states.

What does a bulk park offer?

  • A bulk drug park will have a designated contiguous area of land with common infrastructure facilities for the exclusive manufacture of APIs, DIs or KSMs, and also a common waste management system.
  • These parks are expected to bring down manufacturing costs of bulk drugs in the country and increase competitiveness in the domestic bulk drug industry.

Why Himachal?

  • Himachal already has Asia’s largest pharma manufacturing hub, that is the Baddi-Barotiwala-Nalagarh industrial belt, and the state produces around half of India’s total drug formulations.
  • Himachal offers power and water at the lowest tariffs in the country, and the state also has an industrial gas pipeline.
  • It jumped nine places in this year’s ease-of-doing-business rankings declared by the Centre last month, securing the seventh position in the country.

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

Online Pharmacy Regulation in India


From UPSC perspective, the following things are important :

Prelims level : Pharma sector regulations

Mains level : E pharmacy and its benefits

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

Try this easy question:

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

How is the pharmacy market in India currently shaped?

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

Rules governing the pharma sector

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

What do the draft e-pharmacy regulations propose?

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

Current status

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

Online pharma is growing in scale

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


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

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

Drug pricing and dependence on China


From UPSC perspective, the following things are important :

Prelims level : APIs, NLEM

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

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

Incentives for domestic production of APIs

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

Did drug price control policy increase dependence on China?

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

Understanding the growing dependence on China from the past perspective

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

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


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


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

Decoupling pharmaceutical industry from China should be strategic


From UPSC perspective, the following things are important :

Prelims level : APIs

Mains level : Paper 3- Indian pharmaceutical industry

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

Dependence of Indian pharma industry on China

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

Implications of banning import from China

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

Lessons from the past: Policy initiative matters

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

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

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

Government moves to reduce dependence for API

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

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


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

Back2Basics: What are APIs?

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

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

What are Biosimilars?


From UPSC perspective, the following things are important :

Prelims level : Biosimilars

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

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

The story of simple molecules and some difficult diseases

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

What is biologic?

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

So, Biosimilars are..

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

Utility of patents in the pharmaceutical industry

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

What happens when the patent expires?

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

Why biologics would be difficult to replicate after the patent expires

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

Why marketing a drug in the US gather headline?

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

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


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


Reference Source:

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

Fund for pharmaceutical innovators


From UPSC perspective, the following things are important :

Prelims level : Drug patents

Mains level : Paper 3- Drug pricing issue

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

Medicines: Humanities greatest achievements

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

Issue of high drug prices

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

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

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

Three concerns with R&D

1. Neglect of the diseases suffered by the poor

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

2. High prices of new medicines

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

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

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

Health Impact Fund: Solution to the above problems

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

How health impact fund would work?

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

The fund will have the following 5 major benefits

1. Help the Neglected areas of research

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

2. Rewarding health outcomes and not sales

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

3. Sustainable research and marketing system

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

4. No fear of compulsory licence clause

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

5. Holistic approach

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

Can we apply the above to Covid-19?

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

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


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

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

Private: Pharmaceutical Sector in India – Opportunities and Challenges

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

What is the current status of the Indian pharmaceutical sector?

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

How is the sector regulated in India?

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

What are the government efforts for this sector?

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

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

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

What are the issues and challenges?

On the regulatory side:

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


On the quality side:

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

On the marketing side:

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

On capital and R&D aspects:

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

International aspects:

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

The API issue:

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

way forward

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


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

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

Price Monitoring and Resource Unit (PMRU)


From UPSC perspective, the following things are important :

Prelims level : Price Monitoring and Research Unit (PMRU)

Mains level : Drug prices monotoring mechanisms in India

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

Price Monitoring and Research Unit (PMRU)

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

Its composition

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

Terms of reference

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

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

Why need PMRU?

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

Expected outcomes

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

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

What is an ‘Essential Commodity’?


From UPSC perspective, the following things are important :

Prelims level : Essential commodities

Mains level : Regulation of essential commodities

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

Why such move?

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

What does the government’s declaration mean?

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

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

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

How do states and UTs implement these orders?

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

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

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

Impact on Corona curbing

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

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

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


From UPSC perspective, the following things are important :

Prelims level : Active Pharmaceutical Ingredients

Mains level : Regulations of API

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

Active Pharmaceutical Ingredients (APIs)

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

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

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

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

Medical Devices (Amendment) Rules, 2020


From UPSC perspective, the following things are important :

Prelims level : Medical Devices (Amendment) Rules, 2020

Mains level : Regulation of medical devices in India

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

Medical Devices (Amendment) Rules, 2020

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

What are the items covered under the new Rules?

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

Is this a sudden move?

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

Why was the move required?

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

What are the penal provisions under Indian law?

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

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

WHO prequalifies Serum’s low-cost Pneumococcal Vaccine


From UPSC perspective, the following things are important :

Prelims level : Pneumococcal Vaccine

Mains level : Not Much

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

Pneumococcal Vaccine

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

About the Vaccine

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


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

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