Why Indian regulators fail to prevent fatal lapses in drug manufacturing

It has also asked the World Health Organisation (WHO) for a detailed report on the establishment of causal relation to death with the purportedly contaminated medical products.

Maintaining Good Manufacturing Practices (GMP) and complying with the regulatory code and requirements are the duty of the manufacturers, pharmaceutical industry observers say.

But it is the drug regulatory authorities at the central and state levels who need to inspect manufacturing facilities regularly and identify any lapses.

An investigation in the case by the Central Drugs Standards Control Organization is ongoing but it is likely a major failure- amounting even to criminal neglect—on the part of both the manufacturer and regulators.

Neither V G Somani, the Drug Control General of India, nor Wazeer Singh Goyat, Haryana’s Food and Drug Administration Commissioner, were available to comment when Moneycontrol tried to reach them.

Naresh Kumar Goyal, director of the tainted company, did not answer phone calls. This story will be updated when any of them respond to our queries.

Repeat offender

Vietnam and few states in India have taken action against the Haryana-based drug manufacturer for the poor quality of its drugs over the last several years.

Bihar, in 2011, had even blacklisted the company for supplying a poor-quality paeditaric syrup.

Public health activist Dinesh Thakur pointed out that it is CDSCO which provides an assurance via the Certificate of Pharmaceutical Product (CoPP) to buyers overseas that it has inspected the manufacturing unit and ensured that the exporter complies with WHO’s current good manufacturing standards.

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Pharma companies are required to provide this certificate to the buyer overseas.

“Given the track record above of the company, should not it be asked on what basis was the certificate issued to the company?” asked Thakur, who is launching a book The Truth Pill: The Myth of Drug Regulation in India, co-authored with lawyer Prashanth Reddy.

A health ministry official, who did not want to be on record, conceded that there have been instances in the past when some drugmakers have managed to export substandard drugs to African countries mainly due to regulatory oversight in those nations.

“It’s only when a patient dies after consuming drugs that the cases get highlighted, but patients falling sick after consuming spurious drugs are also reported sometimes,” the official said.

Contamination by design or default?

Senior clinical pharmacologist Dr Santanu Tripathi said cases of default contamination of liquid pediatric formulations with diethylene glycol were not new and keep happening in mainly low- and middle-income countries.

Glycerin or glycerol are organic solvents used in liquid oral medications such as pediatric cough syrups, paracetamol (anti-fever) suspension for children and sometimes in antibiotics syrups, he explained.

“Sometimes manufacturers may use DEG or ethylene glycol, which are cheaper alternatives to glycerin without appreciating the unacceptable risks involved,” he said.

“While glycerine is relatively safe for oral use, DEG or EG can be severely harmful,” said Tripathi.

Contamination with DEG in a medicine indicates compromised quality checks and non-compliance with good manufacturing practices on the part of the manufacturer, Tripathi said. A prompt and proper enquiry can reveal the truth, he said.

To avoid such lapses, the responsibility of inspecting the manufacturing units lies with central and state drug regulatory authorities, he added.

But it is clear, given the frequency of such episodes—the last case of DEG contamination in a cough syrup in India came to light in 2019-20 when 11 children in Jammu & Kashmir’s Udhampur died—that the negligence on the part of both manufacturers and regulators is rampant.

In the J & K case, the license to produce Coldbest PC cough syrup- found to have unacceptable limits of DEG-- to Himachal Pradesh-based Digital Vision pharmaceuticals was cancelled but no charge sheet in the case has been filed yet.

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Previously too, including in 1973, 1986 and twice in 1998 cases of DEG contamination led to mass poisoning. And it’s not contamination with DEG alone that raises questions on the standards of drug quality checks in India. Reports of sub-standard drugs by generic drug makers are routine.

Dangerous nexus

Industry insiders say that after the CDSCO gives the marketing license for a new drug, manufacturing is carried out in different units located in different parts of the country and concerned state controllers, based on the location of the unit, issue the manufacturing license.

A CDSCO official, who did not wish to be named, insisted that the primary responsibility of the regular inspection of the manufacturing units, properly maintaining the good manufacturing practices and complying with the regulatory code and requirements remains with the manufacturers.

Chinu Srinivas, of the All India Drug Action Network-a patient rights group, said that given that there are 20,000-30,000 drug manufacturing units in India and regulators carry out only random batch testing, it’s possible for many spurious drugs to escape the surveillance net.

He also suggested that in many cases of drug contamination and spurious drugs, connivance between unethical drugmakers and regulators cannot be ruled out.

Moneycontrol reached out to the Indian Drug Manufacturer Association and Indian Pharmaceutical Alliance, the two major associations of India-based pharma companies- on what they think of these lapses on the part of manufacturers and regulators -- but had not received responses from either of the bodies before this article was published.

Hollow assurances?

The Centre has been quick in clarifying that the four drugs in question in the latest episode- Promethazine Oral Solution, Magrip N Cold Syrup, Kofexmalin Baby Cough Syrup, and Makoff Baby Cough Syrup - are not sold domestically and have not been exported anywhere except to Gambia.

But activists like Thakur who have been routinely exposing the malfunctioning of the drug regulatory processes in the country, say that export licenses are given to a manufacturer only after “showing” that their unit is WHO-GMP compliant.

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“If a company is supplying a drug outside India, do you think it won’t be supplied locally? Everyone knows how porous the supply chain in India is,” said Thakur.