Author: Dinesh C Sharma
The World Health Organisation in the first week of October issued a global alert on four contaminated paediatric drugs following reports about the death of 69 children due to acute kidney injury in The Gambia. The alert found them to be 'out of specification' after laboratory tests revealed contamination with two industrial solvents - diethylene glycol (DEG) and ethylene glycol. WHO said the manufacturing company - Maiden Pharmaceuticals Limited (MPL) based in India - had not provided the organisation with any guarantees on the safety and quality of these products. The next day, Ministry of Health maintained it was 'a usual practice for importing countries' to test products for quality before their release in local markets. Subsequently, the government formed a panel to investigate the matter and samples of cough syrups were collected from MPL for testing.
This is not the first time such a tragedy has been reported. In January 2020, cough syrup laced with high amounts of DEG caused the death of 12 children in Ramnagar in Jammu. As many as 33 children died after being administered cough medicines contaminated with DEG in Gurgaon in 1998. In such cases, it is likely that industrial chemicals with a similar sounding name were employed negligently instead of propylene glycol, which is typically used to produce cough syrups. This is despite checks mandated for both raw materials and formulations under Good Manufacturing Practices (GMP) rules.
The regulatory system consists of Central Drugs Standard Control Organisation (CDSCO) and 36 state-level drug regulatory agencies. CDSCO deals with new molecules, clinical trials and imported drugs, while state authorities can issue licenses for the manufacture, sale and distribution of drugs. A chief responsibility of state authorities is to conduct periodic checks to prevent the manufacturing and marketing of spurious, adulterated, or sub-standard drugs.
The lack of transparency in the functioning of the regulatory system is a major problem. "Even basic information is not available, like names of medicines licensed for marketing and manufacture in India, brands of medicines in India and MRPs, names of manufacturers, list of vendors and manufacturers of bulk drugs and other ingredients going into a medicine. There is no way of knowing why certain drugs are approved again after being banned, and proceedings of committees which ban or approve them," pointed out S Srinivasan of Locost, Vadodara.
"The first step to solve the problem is to acknowledge that it exists and to bring complete transparency in the functioning of all healthcare regulatory agencies including the National Medical Commission and Pharmacovigilance Programme of India which is tasked with keeping track of all adverse and spurious drug reactions," added Kunal Saha, founder of People for Better Treatment, a patient rights group in Kolkata.
Mahesh Zagade, former head of the Food and Drug Administration (FDA) in Maharashtra state, said that regular inspections of manufacturers were mandated by legislation but during his tenure, he found that "these inspections are casual and perfunctory because records relating to purity, quality and raw
The law needs to lay down the guiding principles for the regulator to carry out its functions, with the central duty being to ensure the availability of safe and effective drugs in the interests of public health. This will provide a clear standard against which to review the performance of the drug regulator.
materials are seldom checked thoroughly." The inspection reports, he said, are not shared even with the FDA commissioner. Unlike in the Western countries, the details of the meetings of the ethics or investigative committees in the National Medical Commission (and other health agencies) are not posted on their website with an intention to keep this secret so corrupt practices are never revealed to the public at large, Saha said. In the developed countries like USA and UK up to half of the members in the medical councils are non-medical people. NMC and state medical councils across India are almost all exclusively doctors raising the obvious question of "conflict of interests" to deliver fair and equitable justice against the errant medicos, medical inspectors and drug manufacturers.
The solution, according to public health activist Dinesh Singh Thakur, is to "centralize licensing function nationwide, appoint honest and competent people and hold them accountable." Thakur filed hundreds of RTI applications in recent years to get information from regulatory authorities about approval of new drugs, banning of harmful drugs and inspection reports. He, along with Prashant Reddy T, has put together this information in the form of book, The Truth Pill. The book exposes holes in the regulatory system, weak and ineffective enforcement of the law, leniency shown by courts and the political interference to shield the industry. The book cites the report of the Parliamentary Standing Committee on Health which in 2012 extensively investigated the functioning of the Central Drugs Standard Control Organisation (CDSCO). The report found widespread violations of rules in the approval of new drugs as well as Fixed Dose Combinations. But the government and the regulator did little to set the house in order. The report of an expert committee set up to investigate suspicious drug approvals mentioned in the parliamentary panel was suppressed and never made public.
An August 2022 report of the Vidhi Centre for Legal Policy has noted that the new drug regulation proposed by the central government should enshrine "a clear set of powers, functions and restraints" without delegating essential functions. The law needs to lay down the guiding principles for the regulator to carry out its functions, with the central duty being to ensure the availability of safe and effective drugs in the interests of public health. This will provide a clear standard against which to review the performance of the drug regulator. The law should make it mandatory for the regulator to make public the rationale behind its regulatory decisions in order to inspire confidence in its ability to protect the health of the public, the report has suggested.
Dinesh C Sharma is a Columnist and
author based in New Delhi
[A shorter version of this article has
appeared in The Lancet
on October 22, 2022]
