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Updated At: Oct 16, 2022 08:52 AM (IST)

The production at Maiden Pharmaceuticals in Sonepat has been halted and a panel is examining the Gambian issue.

The alert by the World Health Organisation (WHO) over the deaths of 66 Gambian infants, suspected to have been caused by the consumption of contaminated cough syrups made by a Sonepat firm, Maiden Pharmaceuticals, has raised serious questions about the probity of drug manufacturing and regulatory practices at home.

Inadequacy of drug inspectors, lack of training

Certification of drugs is must

All drugs meant for exports must henceforth be approved by the national drug regulator, the Central Drug Standards Control Organisation (CDSCO). Prescription precautions must be stated in bold on packages. Not just export material, all drugs meant for domestic consumption must also have certification from government-approved labs. — NK Ganguly, former director-general, ICMR

In 1937, the US witnessed mass deaths due to diethylene glycol (DEG). They created better laws and increased enforcement for testing of drug ingredients. There has been no repeat instance of DEG death in the US ever since. The law in India is clear. But enforcement is lacking. Dr Gopal Dabade, expert on drug sector reforms

Matters have become worse from the knowledge that the WHO-flagged contaminants, found in some samples of the exported syrups, have led to several deaths on five occasions in the past.

Lessons have obviously not been learnt, with top experts now calling for accountability and transparency of drug supply systems, lest people’s faith in the public administration of health is lost forever.

Leading Dharwad-based activist and ENT surgeon Gopal Dabade, who works on drug sector reforms, says the WHO’s October 5 alert is of “immense and serious concern” not just to Gambia but also to India.

“We can choose to ignore this alert at our own peril. In my view, drug regulators are more to blame than the manufacturing firms because the firms will always be driven by profits, but it is the sacred responsibility of the drug regulators to ensure safe medicines are available for both domestic and offshore markets. It is high time we enforce transparent and uniform drug regulatory standards. Right now, standards vary from state to state,” says Dabade, recalling five past instances where drugs laced with the WHO-flagged contaminants diethylene glycol (DEG) and ethylene glycol (EG) led to preventable deaths.

In 1973, 14 children died at a government hospital in Chennai’s Egmore; in 1986, 14 patients died in Mumbai’s state-run JJ Hospital; in January 1988, 11 persons died in Bihar; in 1998, 33 children died in Delhi and Gurugram; and in 2020, 12 infants died in Udhampur’s Ramnagar.

The cause of death in each case was industrial-grade DEG, which impacts kidneys and kills rapidly.

Dabade says systems are in place to ensure drug safety, but manufacturers often cut corners.

“The Indian Pharmacopoeia Commission lays down standards for each drug formulation. The law is clear. Good Manufacturing Practices are also in place. But enforcement is lacking and manufacturers sometimes avoid safety tests or ignore the results, their sole objective being profiteering. Testing of DEG and EG is expensive but that is no excuse to not test,” says Dabade, also associated with the All India Drug Action Network.

He says where there is a will, there is always a way and cites the US example to drive home his point. “In 1937, the US witnessed mass deaths due to DEG. They created better laws and increased enforcement for testing of drug ingredients. There has been no repeat instance of DEG death in the US ever since,” notes the expert, who raises health awareness through Jagruti, a non-profit he founded.

DEG and EG are impurities found in propylene glycol (PG), a solvent used to dissolve paracetamol to prepare cough syrups because paracetamol does not dissolve in water. Under the Indian Drugs and Cosmetics Act 1940 and the Indian Pharmacopoeia, drug firms are mandated to use pharmaceutical-grade PG with nil DEG to prepare formulations. But the problem is the rampant availability of industrial-grade PG which costs less — around Rs 100 a kg as against Rs 170 a kg pharma-grade. Drug manufacturers sometimes choose shortcuts that can prove fatal.

Although the government has now halted the production at Maiden Pharmaceuticals and set up a committee to examine all aspects of the Gambian issue, the outcome of the crackdown will only be known in time.

Leading health administrators are meanwhile calling for urgent reforms.

Former Director-General, Indian Council of Medical Research, NK Ganguly says all drugs meant for exports must henceforth be approved by the national drug regulator, the Central Drug Standards Control Organisation (CDSCO).

“The government must insist that any export material, even if licensed by the State Drug Controller, should be examined and approved by the CDSCO. Presently, not all such consignments go to the national regulator for approval. The CDSCO should further approve only those drugs which have been certified by government-approved labs. Prescription precautions must be stated in bold on packages. In fact, not just export material, all drugs meant for domestic consumption must also have certification from government-approved labs,” says Ganguly.

The former health research secretary also called for testing of every manufactured drug batch before it enters the market, noting that random testing has not helped.

Ganguly also says that drug safety vigilance on firms operating in smaller cities like Sonepat and Kala Amb (where Digital Vision had produced DEG-laced cough syrups that killed 12 infants in Udhampur in 2020) must be very stringent.

Both Dabade and Ganguly point to how the USFDA’s India office tests every Indian drug meant for exports to the US to ensure standards.

“The second largest US FDA office outside of the US is in India. This is because they want to monitor every drug exported to their country and they know that if they do not do this, quality could be compromised,” Dabade says, adding that parents must avoid cough syrups once they have ruled out the following four causes of cough — TB, asthma, heart disease and pollution.

Terming most cough syrups as unscientific and not mentioned in any standard textbook of medicine, Dabade says syrups are a combination of bronchodialators, cough suppressants and anti-allergy compounds which confuse the body and do more harm than good. “If all the above stated causes of cough are ruled out, parents must not give their babies cough syrups at all. Cough is self-limiting and will go away by itself in a week. Syrups can complicate matters,” Dabade notes.

Importantly, the government had in March 2016 banned 349 fixed-dose combinations, including several cough syrup formulations, on the recommendations of the Kokate Committee, which was the first to crack down on unscientific cold and cough drugs flooding the Indian market.

Several drug companies, however, secured court stays on the ban.

Asked if the Indian drug landscape was all bad, NK Ganguly said, “No.”

“Major Indian drug firms operating in the international markets are USFDA-approved and maintain world-class manufacturing facilities. They meet stringent drug safety standards required by the US, Europe, Australia and other developed markets and even South Africa. The problem arises in some least developed (such as Gambia) and developing countries where drug regulators are not recognised. Such countries accept drugs from India because they take the Indian regulator as globally reputed and reliable,” explains Ganguly, admitting that India’s image as the pharmacy of the world “is robust but has, no doubt, taken a hit after WHO’s October 5 alert”.

Hopefully, reputed manufacturers will take stock and enforce pan-industry standards, Ganguly says.

While the government’s next steps on Maiden Pharmaceuticals will be closely watched, past experience with DEG poisoning investigations and outcomes has been heartbreaking, to say the least.

Corruption in licensing, manufacturing and purchase practices appears rampant 34 years after the Justice Bakhtawar Lentin Commission report (made public in 1988) indicted everyone — from the bottom rung of the drug regulatory system to then Maharashtra Health Minister Bhai Sawant — for 14 deaths due to industrial glycol at Mumbai’s JJ Hospital in early 1986.

The report led to Sawant’s resignation and concluded that the deaths were a result of “misuse of ministerial power and authority, and apathy towards human life”.

The first-ever official document detailing the state of Indian drug regulation system said that the JJ Hospital tragedy had occurred because the Maharashtra Food and Drug Administration had granted an illegal licence to Alpana Pharma, the supplier of the killer drug to the hospital. The Lentin Commission further revealed how the hospital’s drug purchase committee bent every rule in the book to place orders with Alpana Pharma, whose owners exercised tremendous political clout.

It remains to be seen if similar favours were granted to Maiden Pharmaceuticals in Sonepat.

Meanwhile, what is amply clear is that the firm did not test propylene glycol for contaminants DEG and EG, which it needed to. Testing these toxins requires an instrument called chromatography, which costs around Rs 15-20 lakh per unit. Although the Haryana Drug Controller allows outsourcing of the test considering few drug companies can afford it in their indigenous labs, many firms tend to skip this life-saving test.

While the world keenly watches how India responds to the Gambian tragedy, Gopal Dabade makes a compelling case for enhanced drug regulation. “Just as war is too important to be left to the Generals, drugs are too important to be left to drug manufacturers,” he cautions.

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