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 .