Indian pharma in dire need of smart regulation

Drug regulator Central Drugs Standard Control Organisation (CDSCO) has done a commendable job by detecting toxicity in a cough syrup and an anti-allergy syrup manufactured by Norris Medicines. The syrup apparently contaminated either diethylene glycol (DEG) or ethylene glycol (EG), the same chemicals in the cough syrups that killed 141 children worldwide since the middle of last year with the maximum deaths reported in Gambia, Uzbekistan, and Cameroon.H.G. Koshia, Commissioner of Gujarat’s Food and Drug Control Administration, clarified that they had inspected Norris’ factory last month and ordered it to suspend production. According to him, the company was found wanting on compliance parameters of good manufacturing practices and water system while the air-handling unit was also not up to the mark. CDSCO also found that three batches of Cold Out syrup made by Fourrts (India) Laboratories were contaminated with DEG and EG.

It is a matter of grave concern that even after the horrifying tragedy leading to the death of so many children in different parts of the world, there are still many businesspersons, whose approach towards safety is casual and rather laidback.

This is inexcusable in a sector where quality of products cannot be compromised as this could have fatal consequences. Incidentally, the news of deaths caused by contaminated syrups supplied by Indian companies was broken by the World Health Organization (WHO). Further, the news of contamination too has come out because of the alertness of CDSCO. This is progress. A great deal, however, has to be done. One cannot be sluggish on such a critical subject, which can cause innumerable deaths. It is unfortunate that decision makers from the pharmaceutical sector still seem to have a cavalier approach on this front. Ironically, Fourrts chairman S.V. Veeramani heads the government-backed Pharmaceuticals Export Promotion Council of India. He had said in August that “analysis of retention samples” of Cold Out showed that there was “no contamination or toxins. There is no report of any adverse effect or death due to the product. As a matter of abundant caution, we have voluntarily recalled the product in Iraq market.” The world is ridiculing this contention justifiably so given the individual’s clash of interests.

It may be mentioned that the WHO had said in August that a batch of Cold Out sold in Iraq had unacceptable levels of DEG and EG. This seems to suggest that Fourrts did not export quality products to Iraq. Also, the CDSCO erred in letting the shipment reach the Middle East nation. Two points need to be made here. First, the CDSCO officials’ attitude towards adulterated drugs should be the same as that of competent anti-terror cops: they have to succeed every time, failing which there would be a mishap. Second, the CDSCO must ensure that quality checks are smart and not ham-handed, lest the spectre of ‘inspector raj’ come to haunt the industry. Targeting the unscrupulous without troubling the honest is the hallmark of smartness.