Urgent reforms to ensure safe medicines: Need of the hour

Global achievements of Indian pharmaceutical industry

Largest Exporter of quality medicines to High Economy Countries (HICs):

The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on from a turnover of approx. US $ 1 billion in 1990 to over US $30 billion in 2015 of which the export turnover is approximately US $ 15 billion. The country now ranks 3rd world wide by volume of production and 14th by value, thereby accounting for around 10 per cent of world’s production by volume and 1.5 per cent by value. Globally, it ranks 4th in terms of generic production and 17th in terms of export value of bulk actives and dosage forms. Indian exports are destined to more than 200 countries around the globe including highly regulated markets of High Income and highly regulated Countries like US, West Europe, Japan, and Australia.

Large Indian pharma companies have emerged among the most competitive in the evolving generic space in North America and have created an unmatched platform in this space. Now Indian companies are also making their presence felt in the emerging markets around the world.

 

Strengths of Indian pharmaceutical industry-

Largest Exporter of affordable medicines to Middle Income & Low-Income countries (MIC& LICs):

India was capable of manufacturing low-cost generic alternatives due to several economic factors favouring the industry for exports to Middle Income & Low-Income countries. Some of these economic factors include the competitive land rates, the cheap labour available, low resource costs like water, electricity., lower cost of production machinery etc. 

Breaking the monopoly of multinational companies:

Once there was the monopoly of multinational companies which were formulating monopolistic international trade laws like Patent Laws to sell their products at very high cost that were unaffordable to MICs & LICs. This was a period when these countries could not procure even lifesaving medicines during epidemics because of these monopolistic Patented high costs.  However, India developed high capacity along with adoption of high technology and that helped India in two ways. Firstly, to produce and make the monopolistic lifesaving medicines affordable to domestic population and secondly also to the population of MICs and LICs. This  strength made India not only to become self-dependent but also helped to break the monopolistic nature of international business, and modify the Patents laws in favour of MICs & LICs by introducing Compulsory Licensing & Voluntary Licencing Laws and making the lifesaving medicines available at affordable cost. 

This further made large Indian pharma companies emerge as among the most competitive in the evolving generic space globally and have created an unmatched platform in this space. Now, Indian companies are also making their presence felt in the emerging markets around the world, particularly with a strong portfolio in anti-infective and antiretroviral. This capacity made Indian companies like CIPLA  to supply lifesaving medicines like medicines for HIV-AIDS and vaccines to African countries during epidemic of these diseases and helped in saving lives of millions of African people.  

Current growth of Indian pharmaceutical industry:

This competitive market also made it possible for the emergence of several second-tier Indian companies with new and innovative business models. As a result, India currently has over 3,000 pharmaceutical companies operating through around 10,500 manufacturing units spread all over country.

 

The changing global image of Indian pharmaceutical industry:

India’s pharmaceutical industry, celebrated during the COVID pandemic for exporting drugs, medical equipment, and vaccines, but now faces a credibility test. Often called the “pharmacy of the world,” now it confronts a growing crisis driven by counterfeit and substandard medicines. 

A recent tragedy—the deaths of over twenty children in Madhya Pradesh and Rajasthan after consuming a toxic cough syrup—has intensified the scrutiny regarding safety of medicines. Since 2022, similar contamination incidents involving Indian syrups in The Gambia, Uzbekistan, and Cameroon have aggravated concerns. Together, these episodes raise urgent questions about drug regulation in India, especially the adequacy of national safety oversight, quality standards, and enforcement. 

Concerns related to drug regulation in India:

Multiple government bodies:

Drug regulation in India involves multiple government bodies and laws, both for domestic and exported drugs. To name a few there are Centrally operating CDSCO, Local Licensing authorities State FDA operating in all Indian States , Drug Price Control Order (DPCO- NPPA) authorities, The Directorate General of Foreign Trade (DGFT), Export Inspection Council (EIC), the Foreign Trade (Development and Regulation) Act, 1992, and international authorities like The World Health Organization (WHO) and United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) etc

Low convictions: The conviction rate is about 5.9 per cent, and after procedural adjustments it rarely crosses 3 per cent, which shows weak investigations and poor case preparation.

Outdated legal tool: The Drugs and Cosmetics Act, 1940 was designed for a different era and does not address today’s transnational, organised counterfeiting networks.

Police exclusion: Following the Ashok Kumar (2020) ruling, only drug control officers can register offences under the D&C Act, which has created an enforcement gap that criminals exploit.

Narrow investigations: Most cases stop at seizing spurious stock and do not trace the wider network, its finances, or the facilitators behind it.

Weak intelligence and forensics: Agencies seldom use data analytics, forensic mapping, packaging and ink analysis, digital trails, or CDR analysis, so evidentiary chains remain fragile.

Fragmented agencies: Drug Control, police, the Enforcement Directorate, Income Tax, and GST authorities often work in silos, which limits coordinated action.

Evidence gaps: Scientific validation is inconsistent, reducing the admissibility and persuasive strength of evidence in court.

Poor pharmacovigilance: Pharmacovigilance is the process of monitoring the safety of medicines once they are on the market. In India, the pharmacovigilance system is still developing, and there is a lack of awareness among healthcare professionals and patients about reporting adverse drug reactions (ADRs) resulting in inadequate Post marketing Surveillance. For example, there have been reports of adverse reactions to the COVID-19 vaccine in India, but these have not been adequately investigated.

The poison in the bottle: Repeated wake up calls but left unattended even after several deaths:

Recently, during September & October 2025 a report from Madhya Pradesh and Rajasthan revealed that 26 children lost their lives due to poisoning from contaminated cough syrup. This incident has raised concern due to previous similar occurrences. Investigations swiftly identified the culprit: Coldriff Syrup manufactured by Sresan Pharmaceuticals, situated in Tamil Nadu. Tests revealed it contained 48.6 per cent Diethylene Glycol (DEG), a deadly toxin almost 500 times higher than the legally permitted limit. Further inspection of the factory exposed gross violations: use of non-pharma-grade chemicals, corroded equipment, absence of quality assurance systems, and negligent operating procedures. A perfect recipe for disaster -created not by accident, but by negligence and apathy.

History repeats, but no learning lessons: 

This tragedy is not isolated — it’s a recurring nightmare. In 2019–2020, 11 children died in Jammu & Kashmir due to substandard cough syrup later found to be distributed across several states. In 2022, over 70 children in The Gambia and 18 in Uzbekistan died after consuming Indian-made cough syrups contaminated with the same DEG. In 2024, in Ballari District Hospital, Karnataka, 34 women underwent C-sections; 7 suffered serious complications, and 5 died — suspected due to contaminated IV fluids. These tragedies occur mainly in India and low-regulation African countries — never in developed nations where drug quality is strictly regulated.

India’s unequal drug quality paradox

India has over 3,000 pharmaceutical companies operating around 10,500 manufacturing units. Yet only 1,400 are WHO-GMP certified, only 260 comply with US-FDA standards, and only 253 are approved by the European Directorate for Quality of Medicines. Thus, world-class medicines are produced in India but only for foreign developed markets. Poor citizens in India and Africa receive substandard products — and the government remains indifferent. Each time, there’s outrage, arrests, temporary bans, and committees of inquiry. A show of action follows every tragedy — but soon, silence returns.

Regulatory paralysis – A habit of reaction, not prevention:

This is not just policy paralysis — it is a mirror of our regulatory mindset. We only act when our international image is at stake. When global criticism rises, we pretend to tighten rules.  when it comes to protecting Indian consumers, we remain lax and lenient — as if domestic patients are experimental subjects whose suffering reassures remains un attended.

The Mashelkar Committee’s Warning (2003): Ignored nearly for two Decades

In 2003, Dr. R.A. Mashelkar’s Committee studied India’s drug regulatory system and identified critical deficiencies: underdeveloped testing infrastructure, shortage of trained manpower, fragmented regulatory authority, and weak penalties for substandard manufacturing. Two decades later little has changed.

 

A crisis ignored, a system in reverse gear-from strengthening to diluting: 

The Jan Vishwas Paradox-

Dr. Mashelkar had urged for stronger enforcement, but the 2023 Jan Vishwas Act increased decriminalisation (Compounding of Offenses) — converting serious drug offences into monetary fines. Serious public health crimes will be now treated as mere in process errors. This law decriminalises 42 central laws, replacing imprisonment for minor offenses with monetary penalties & civil penalties. 

The licensing loopholes: Remained unattended –loan licenses and third-party manufacturing

Drug Licensing Authorities often issue Loan and Third-Party Manufacturing Licenses. Big pharma companies misuse them by outsourcing production to small firms while retaining brand names. When drugs fail quality tests, blame shifts to the smaller manufacturer -profits remain, accountability vanishes.

 

When Justice spoke – The J.J. Hospital case (1986):

In 1986, at Sir J.J. Hospital, 13 patients died due to DEG-contaminated glycerine. I took a learning from it. And I, as a Head of Procurement, introduced a condition in Maharashtra’s 2003 procurement policy to allow purchases only from manufacturers having WHO- GMP export license and own their production units. The Bombay High Court upheld this decision, declaring: “If it is true that Health is Wealth, Public Health is National Health… such condition cannot be said to be unreasonable but asking for a export quality medicines in public health care is in public interest.”

India’s global image: From ‘affordable medicines’ to ‘assured quality’:

Until now, India has been known as the ‘pharmacy of the world’ — for being low-cost, not necessarily safe. It is now time to shift that image. India must become the nation that delivers both affordability and assured quality. In future, global trust in Indian pharma will depend on quality, and not affordability.

The road ahead: From reaction to prevention:

If India truly wishes to protect its citizens and preserve credibility, fundamental reform is non-negotiable. The government must recognise drug safety as a national mission, create one unified regulatory authority, enforce real-time public disclosure of violations, and strengthen labs and training.

Conclusion: A moral responsibility:

These tragedies are not just policy failures — they are moral failures. Every DEG poisoning and contaminated IV death remind us that our weakest citizens pay the price for our weakest systems. India must evolve from being the world’s affordable pharmacy to the world’s most reliable one also. Only then can we truly say as Justice Lentin said: Public Health in India is National Wealth, and that wealth is not for sale.