Lancet features report on Gambian deaths linked to Indian drugs

New Delhi, October 21

The Lancet in its latest edition has featured the tragedy involving the death of 69 Gambian children potentially on account of contaminated cough syrups manufactured by a Haryana-based firm. Writing about the tragedy, author Dinesh Sharma reveals the challenges of the Indian drug regulatory sector with top experts suggesting strict and central licensing of all drugs. Sharma, in his report, details how infant deaths had exposed the chinks in drug regulation in India.

The report quotes industry experts as saying that drug makers take many shortcuts. “Manufacturers take shortcuts hoping no one will be looking, either the regulators here or in the importing country”, says

S Srinivasan of Low-Cost, Vadodara.

Regular inspections of manufacturers are mandated by legislation, but “these inspections are casual and perfunctory because records related to purity, quality and raw materials are seldom checked thoroughly,” notes Mahesh Zagade, former Food and Drug Administration Head, Maharashtra, in the Lancet article.

Vidhi Centre for Legal Policy says the lack of hierarchy (between the national drug regulator and state drug authorities) leads to fragmentation as they are legally entitled to function autonomously.

“The result is ineffective regulation and non-uniformity in the quality of drugs marketed across India,” the legal experts note. Srinivasan is quoted by Lancet as saying that “Even basic information is not available. There is no way of knowing why certain drugs are approved again after being banned and the proceedings of committees which ban or approve the drugs.”

On solutions, the Lancet report says: “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 drugs.”