A four-member panel under Dr Y K Gupta, which was earlier tasked by the government to investigate the deaths of 70 Gambian kids purportedly due to the consumption of adulterated cough syrups supplied by a local manufacturer, is likely to be asked to also probe the latest case involving Marion Biotech.
Gupta is the Vice-Chairman of the standing national committee on medicines.
The Uzbekistan government has said that 18 kids in the country died after consuming DOK-1 Max, a cough syrup manufactured by Noida-based Marion Biotech. Initial laboratory testing has shown that the syrup was contaminated with ethylene glycol, a toxic substance.
Senior officials in India’s health ministry said that the Gupta committee, constituted in October this year, is set to be asked to examine and analyse the adverse event reports, causal relationships, and all related details to advise the DCGI (Drugs Controller General of India) about the further course of action.
“Since the Gupta committee has already been studying the earlier case involving Maiden Pharmaceuticals and the latest case is very similar, we would ask them also to probe the episode and suggest what measures need to be taken to prevent such instances,” said a top official in the ministry.
In October this year, Haryana based Maiden Pharmaceuticals was at the centre of a major controversy after the World Health Organization (WHO) said that four of its cough syrups supplied to Gambia had been found to be contaminated with diethylene glycol, a toxic compound, and linked it to the deaths of 70 kids in the African country.
Also read | Uzbekistan cough syrup row: Marion Biotech asked to completely halt drug production at Noida plant
India’s drug regulator, after testing the control samples of the cough syrup batches supplied to Gambia, however, said that there was no contamination in the medicines. Earlier, it had stopped all drug production by Maiden Pharmaceuticals after finding several violations of Good Manufacturing Practices (GMP).
The panel’s work so far
The Y K Gupta committee, which has representatives from the National Centre for Disease Control, National Institute of Virology, and the Central Drugs Standard Control Organisation, has met several times, but in the absence of a causality assessment report from Gambia and the WHO, the panel has not been able to make much of headway.
In a recent letter to the WHO, V G Somani, the Drug Controller General of India lambasted the United Nation’s health body for not sharing the causality assessment report and for “tarnishing the image of India’s pharmaceutical industry.’’
Somani had, however, written that it may permit WHO representatives to interact with the technical committee directly if required.
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