Govt orders new drug making standards after overseas deaths

The Indian government announced new manufacturing standards for pharmaceutical companies on Saturday, an action that sparked small companies to request a delay due to their heavy debt burdens. The government's decision comes after a series of foreign deaths were linked to Indian-made medicines since 2022, leading to increased scrutiny of pharmaceutical factories to improve the reputation of the $50 billion sector. The new decree, issued on December 28th, states that manufacturers are obligated to ensure their products are safe, effective, and abide by licensing requirements. Only after satisfactory testing can companies market their finished product, and they must keep a sizable quantity of samples for repeated tests or batch verification. Inspections of 162 drug factories since December 2022 revealed a lack of raw material testing, according to the health ministry's report in August. Less than 25% of India's 8,500 small drug factories meet the international drug manufacturing standards set by the World Health Organization (WHO). The directive requires larger pharmaceutical companies to address these issues within six months, and smaller manufacturers within a year. Smaller companies have called for an extended deadline, claiming that nearly half of them could be forced to close because of the investments needed to meet the regulations. Indian cough remedies have been linked to at least 141 children's deaths in Gambia, Uzbekistan, and Cameroon, according to WHO and other health agencies. Livemint becomes the fastest growing news site worldwide. Discover a multitude of benefits! Gain access to insightful newsletters, live stock tracking, breaking news, and a personalized news feed at just a click away!