NEW DELHI – Is the pill you’re popping safe? Well, one cannot be certain. Several highly popular medicines in India are being sold without having undergone clinical trials to check for their safety.
In a damning report by the parliamentary standing committee for health and family welfare, which looked at the functioning of the country’s highest office on drugs – the Central Drugs Standard Control Organization (CDSCO) – 33 new medicines were found to have been approved between January, 2008, and October, 2010, without undergoing human trials. According to the Committee, on an average, the Drug Controller General of India (DCGI) is approving one drug every month without trials.
In a separate scrutiny of 39 randomly picked drugs in India by the panel, it found that in case of 11 drugs (28%), mandatory phase-III clinical trials were not conducted.
Some of these drugs belong to reputed firms like Novartis, Cipla and Eli Lily. In the case of two drugs (Dronedarone of Sanofi and Aliskiran of Novartis), trials were conducted only on 21 and 46 patients, respectively, as against the stipulated 100.
