New Delhi: Despite growing demands for laws mandating recall of drugs found ineffective or unsafe after reaching the market, latest norms by the Central Drugs Standard Control Organisation (CDSCO)—the country’s apex drug regulator—have been issued in the form of “guidelines”.
Guidelines on recall and rapid alert system for drugs (including biologics and vaccines) were released last month, over seven years after the issuance of the previous set of guidelines. But, except for reformatting of procedures and the documentation process, there are no changes in the new guidelines.
India, which takes pride in calling itself ‘pharmacy to the world’ has been on the backfoot over the last couple of years following multiple episodes involving Indian drugs, mainly cold and cough syrups, leading to serious adverse events including deaths in some countries.
These episodes have led to a collective call to ensure optimum quality of drugs manufactured in the country and to put in place strict deterrents and safeguards, including drug recall backed by force of law, to safeguard public health.
In the newly released guidelines, the CDSCO conceded that while there are references to product recalls, complaints and adverse reactions in a certain schedule in the Drugs and Cosmetics Act & Rules, there is at the same time a need for effective and uniform recall procedure, with timelines at every level of the supply chain.
At present, auditing and accountability are not in place.
The drug regulator said the new guidelines are “expected to be followed by all licensees—manufacturers, importers, exporters, stockists, distributors, retailers and the recall could be voluntary or statutory”.
The procedure may also be used by central or state drugs control authorities when urgent action is required to protect public or animal health.
According to the latest norms, “These guidelines would help in adopting to stepwise procedures to be followed in recall strategy and also help in recall evaluation at every level and achieve compliance within the time frame.”
The norms define recall as removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws.
But public health activists point out that unless a drug recall policy with legal backing—framed by the Union health ministry—is brought in, the guidelines will not serve any purpose.
“If, for example, there is a violation of these guidelines, what is the recourse available to the CDSCO? Nothing. That is my biggest concern with this,” Dinesh Thakur, a public health expert focused on improving health policy in the US and India, told ThePrint.
ThePrint reached Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi over call for comment. This report will be updated if and when a reply is received.
