Death of infants

Drug recall process leaves much to be desired

Death of infants

Once a batch of a drug is detected to be hazardous to the health and lives of potential patients, it becomes absolutely essential to trace — on a priority — every pill or potion out on the market. Ever since the death of 12 infants last month in the Ramnagar area of Udhampur district in Jammu and Kashmir has been traced to an impurity detected in the September 2019 batch of 5,500 bottles of Coldbest-PC Syrup, the drug regulatory authorities have pulled out all stops to reach out to its buyers and to recall the unsold stock. Given that the spurious product has found its way into not only J&K but also across Haryana, Tripura, UP and Himachal Pradesh, the hurdles that the drug inspectors are facing in withdrawing the dangerous medicine once again exposes the loopholes in our system of regulatory checks. Even as stringent action against the erring firm/s has been rightly initiated, protection of the potential consumer from a harmful syrup is compromised in the absence of an integrated regulatory framework for product recalls.

It was partly because of a loophole in safety regulations that the Indian recipients of faulty Johnson and Johnson hip implants were at a disadvantage vis-a-vis those of Australia and the US. While the J&J recalls took place in 2010 in these countries, our controllers took notice only in 2017. And, sadly, the Indian patients got a paltry sum in compensation; many of them even lost out on it and the revision surgeries as they were ignorant of their entitlement or could not be traced. It reflects poorly on our system and procedures.

India is the largest provider of generic drugs worldwide and the expanding industry is bound to throw up safety concerns. Stringent quality standard regulations and consumer protection laws are in place to deal with them. The remedy lies in strong enforcement of rules aided by hi-tech mapping of data. The offenders must be administered the bitter pill.


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