Corruption, Contamination, and Crisis

Potential erosion of trust confronts India’s pharmaceutical industry as substandard medicines continue to thrive and claim lives. From Gambia to Uzbekistan, several countries have suffered the consequences of systemic failures in both oversight and enforcement within India’s drug regulatory framework, leading to the preventable deaths of innocent victims, often children, who are more vulnerable.
By Dr Amitav Banerjee

With great privilege comes greater responsibility, particularly the responsibility of ensuring quality control and safety. Unfortunately, India has outdated regulations—or no regulations at all—in some critical areas. Even the old regulations are applied with kid gloves by drug regulators, inspectors, and the judiciary, who tend to condone manufacturers of substandard drugs.

In the race for fast growth in the pharmaceutical industry, quality and safety are being sacrificed, often at the cost of innocent human lives. Recent amendments to the Drugs and Cosmetics Act of 1940, such as the Jan Vishwas Bill, instead of making drug regulations stricter, have introduced provisions whereby a manufacturer of substandard drugs can be let off by paying a monetary fine instead of facing imprisonment. The present narrative describes the tragedies that have resulted from lax drug regulations in our country.

Recent cases of such tragedies have occurred in foreign lands due to drugs imported from India, tarnishing the image of the country known as the “pharmacy of the world.” Cases of substandard drugs lead to inquiries that are long and protracted, followed by court cases that are even longer and never-ending, with manufacturers of substandard drugs often continuing business as usual, while justice is denied to the victims.

A Chequered Past and Lessons Not Learned
Over the years, drug regulation in India has gone from bad to worse. In 1986, after the deaths of 14 patients due to the consumption of glycerine contaminated with diethylene glycol (DEG) poisoning at the prestigious J J Hospital in Bombay (now Mumbai), the Chief Minister of Maharashtra appointed Justice Bakhtavar Lentin, a sitting judge of the Bombay High Court, to head a commission of inquiry into the tragedy.

The Lentin Committee produced an inquiry report spanning 300 pages, which indicted the Joint Commissioner of the Food and Drug Administration (FDA) in Maharashtra and did not even spare the State’s Health Minister from accountability for the tragedy. The report’s findings received wide coverage in the media, leading, albeit temporarily, to censure and suspension for many involved. The State’s Health Minister had to resign, and senior officials of the State FDA, including the influential Joint Commissioner, were suspended. Several senior doctors at J J Hospital also faced suspension.
The Lentin Report summed up the problems of drug regulation in India. The executive summary is scathing, stating:
“These pages describe and illustrate the ugly faces of the human mind and human nature, projecting errors of judgment, misuse of ministerial power and authority, apathy towards human life, corruption, and quid pro quo between unscrupulous license holders, analytical laboratories, elements in the industries department controlling the awarding of rate contracts, manufacturers, traders, merchants, suppliers, the FDA, and persons holding ministerial rank. None of this will be palatable to the affected quarters. But that cannot be helped.”
The Lentin Report was tabled around 1986. Did the detailed inquiry and its recommendations bring about the needed change, or did it get confined to the pages of history? Unfortunately, unfolding events suggest the latter.
The 14 deaths at J J Hospital in 1986 may be just the tip of the iceberg. According to court documents, 150 patients in other hospitals across Maharashtra were also affected or disabled by the same batch of glycerine contaminated with DEG.
Defaulting Firms Continue Business as Usual, Greasing the Palms of Regulators
The Lentin Report held the staff of J J Hospital accountable for poor communication and lack of swift action in withdrawing the stock of glycerine contaminated with DEG. Justice Lentin observed, “The success of any system must ultimately depend on the integrity and efficiency of those manning it, and if these attributes are found at the top, they must percolate downwards. It is here that the system has utterly failed, resulting in the kind of tragedy that struck J J Hospital.”
The Lentin Commission also exposed the loopholes in the drug procurement systems of public hospitals, which allow for corruption at a huge public cost. It was revealed that the FDA granted a license to Alpana Pharma, which supplied the contaminated drug illegally, without ensuring that basic standards of quality were met. Ramanlal Karwa and his brothers, the owners of Alpana Pharma, enjoyed special status in the corridors of power. Even after their company was found responsible for supplying the killer product, the Karwa brothers, instead of facing imprisonment, continued to supply medicines to public hospitals under a different company name. Hospital administrators, on their part, went out of their way to place orders with them, exceeding the ceiling set by the industries department in their rate contract. Money was allegedly deposited in the private bank accounts of the committee members placing the orders.
The Case Drags on for Four Decades in the Courts with No Justice in Sight
Though two charge sheets were filed in the case in 1990, the J J Hospital tragedy illustrates the difficulties that victims of adulterated drugs face in seeking justice. Nearly four decades on, the case continues to be heard at a metropolitan magistrate’s court in Mumbai, but charges have still not been framed against the 24 people accused. Since the hearings began in 1991, two of the accused have died, while one is absconding. Most of the other accused are now between 70 to 90 years of age.
The Lentin Report, which pinpointed lapses at all levels leading to the tragedy, should have been sufficient evidence to convict those responsible, provided we had a strong and efficient system of justice. Unfortunately, the reality is different. Even after almost four decades, the case languishes in the courts. No amount of rules and regulations can compensate for the lack of accountability by the courts in convicting offenders within a reasonable timeframe. Justice delayed is justice denied.
The greater fallout of such a laissez-faire attitude is that it fails to convey a sense of urgency to the pharmaceutical industry to set its house in order. Only quick and harsh punishments for acts of commission and omission that put human lives at stake can act as a deterrent.
Lessons from Military Leadership during World War II
Drawing a lesson from the Second World War, Field Marshal William Joseph Slim, in his memoirs titled Defeat into Victory, narrates:
“Good doctors are of no use without good discipline. More than half the battle against disease is not fought by doctors but by regimental officers. It is they who ensure that the daily dose of mepacrine (an anti-malarial tablet used in World War II) is taken… If mepacrine was not taken, I sacked the commander. I only had to sack three before the rest got my message. Slowly, but with increasing rapidity, as all of us—commanders, doctors, regimental officers, staff officers, and NCOs—united in the drive against sickness, results began to appear. On the chart that hung on my wall, the curves of admissions to hospitals and malaria in forward units sank lower and lower until, in 1945, the sickness rate for the whole 14th Army was one per thousand per day.”
Crises like wars—and perhaps the one surrounding spurious drugs circulating in the market—bring out both the worst and the best in humans. We should strive to identify the best. Military leaders like Field Marshal Slim had the capacity to turn defeat into victory. Lessons from such military leadership, if adopted by our stakeholders—including doctors, drug inspectors, regulators, and the judiciary—can bring about the required reforms. Of course, all involved must have the courage to stand up to political interference.
History repeats itself on foreign soil
Fast forward to recent times. In October 2022, the WHO issued a global alert on four cough syrups made in India, following the death of 69 children due to acute kidney failure in Gambia. Laboratory tests revealed that the cough syrups were contaminated with two highly toxic chemicals, diethylene glycol (DEG) and ethylene glycol, which are industrial solvents.
Before we could recover from the news of this tragic event, within a span of a couple of months, a similar tragedy occurred in Uzbekistan, where 19 children died after taking cough syrup manufactured in India. Once again, the deaths were linked to contamination of the cough syrups with DEG.
These tragedies are entirely preventable with proper checks and balances.
The first instance of large-scale DEG poisoning occurred in 1937 in the USA. Sulpha drugs had recently been invented, and a manufacturer wanted to make a liquid preparation of the antibiotic for children. They ended up using DEG as a solvent, unaware of its poisonous nature. After the drug entered the American market, a total of 105 patients—including 34 children—died. The chief chemist of the manufacturing plant committed suicide.
After this tragedy, drug regulations in the US became more stringent with a focus on safety. The US has never witnessed a single case of DEG poisoning since then. Alas, the same cannot be said for India and other developing countries, including those that import drugs from India.
Developing countries are facing these tragedies repeatedly, an indication of lax drug regulation.
DEG poisoning has remained a recurrent phenomenon in the developing world. DEG poisoning killed 7 children in South Africa in 1969; 47 children died of DEG toxicity in Nigeria in 1990, and 84 again in 2018; 236 children died in Bangladesh between 1990–92; 29 people died in Argentina in 1992; 88 children died in Haiti in 1996; and 365 people died in Panama in 2007.
India’s report card on DEG poisoning is equally dismal. It has had five major DEG poisoning events. The first occurred in Madras (now Chennai) in 1972, killing 15 children. The second in Mumbai in 1986 was at the famous J J Hospital, killing 14 patients. The third in Bihar in 1988 killed 11 patients. The fourth in Gurgaon in 1998 saw 33 children die after consuming cough syrup contaminated with DEG. The most recent victims were 12 children from Ramnagar, Jammu, as recently as 2019.
These tragedies were entirely preventable through the strict implementation of safety measures by pharmaceutical companies, combined with an overhaul of drug regulations. However, Indian pharma companies often fail to test either the raw materials or the final product before releasing it to the market, violating the Good Manufacturing Practices (GMP) laid out in Indian law, which mandates testing of both raw materials before they are used in production and the final drug sample before mass distribution.
Drug regulatory system in India is unwieldy and toothless.
The drug regulatory system in India consists of the Central Drugs Standard Control Organisation (CDSCO) and 36 state-level regulatory agencies. The CDSCO deals with new drugs, clinical trials, and imported medicines. The state authorities issue licenses for the manufacture, sale, and distribution of drugs. An important role of the state authorities is to carry out periodic inspections. This is supposed to prevent the manufacture and distribution of spurious or adulterated drugs. Since Independence, the buck has been passed to and fro between the central and state agencies, with ill-defined roles and a lack of accountability in implementing regulations. Inter-state jurisdictional ambiguities also give rise to many loose ends. Ill-defined hierarchies between the CDSCO and state drug authorities lead to a lack of accountability. This results in poor regulations and a lack of uniformity in drug quality across India.
Adding to the problem is the lax and lenient implementation of the letter of the law. Manufacturing drugs that are not of standard quality (NSQ) is a serious offence, punishable by imprisonment and hefty fines. But often, as documented in The Truth Pill, judges impose a fine of a few thousand rupees and a sentence of “simple imprisonment till the rising of the court.”
Jan Vishwas Bill: An amendment to the Drugs and Cosmetics Act, 1940 sends the wrong signal.
The Lok Sabha on 29 July 2023 and the Rajya Sabha on 2 August passed the Jan Vishwas (Amendment of Provisions) Bill. It essentially decriminalises 183 provisions in 42 laws, ostensibly to promote ‘ease of doing business’ in the country.
An amendment to the Drugs and Cosmetics Act, 1940, proposed in the Jan Vishwas Bill, introduces a provision for ‘compounding’ some offences, i.e., paying a fine instead of facing imprisonment. The bill amends Section 27 (d) of the Drugs and Cosmetics Act, 1940, allowing for the ‘compounding’ of offences that can be settled, where the complainant can agree to withdraw the charges.
On the surface, it aligns with the catchphrase ‘minimum government, maximum governance,’ supposedly making India a preferred country for the pharmaceutical industry. Whether this will compromise the safety and health of the people is a concern. In the race to become the pharmacy of the world, will quality suffer? Whatever the case, it certainly sends the wrong signal of leniency to the pharmaceutical industry.
Dinesh Thakur, author of The Truth Pill, which created quite a flutter, tweeted, “The Lok Sabha passed the Jan Vishwas Bill 2023 with little debate. This bill fulfils a longstanding wishlist of the industry that if you suffer bodily harm from substandard medicine, no one will be held punitively accountable.”
A Member of Parliament expressed concerns: “When we buy a medicine, we assume the government has verified that it will work and it won’t harm us. But the proposed amendment will now reduce punishments for medicines that are not of standard quality. It benefits big business but harms all of us. Very dangerous.”
The path to reform
Democratising regulations, empowering citizens with information and the right to participate, and increasing accountability in public procurement are the keys to reform. Patient protection needs to be streamlined: while thorough testing and clinical trials are necessary to ensure drug safety, companies must be penalised for any lapses in the quality of drugs they supply.
This calls for an urgent re-strategising of the Indian pharma regulatory framework to focus on the quality of drugs, bringing patient safety back to the forefront of the discussion. There must be greater consultation among patients, families, civil society, doctors, parliamentarians, and policymakers because human lives are at stake.

(The author is a renowned epidemiologist and currently serves as Professor Emeritus at a Medical College in Pune, India. Having served as an epidemiologist in the armed forces for over two decades, he was recently ranked in Stanford University’s list of the world’s top 2% scientists.)