Govt: Drugmakers must ensure good manufacturing practices

All drugmakers in India must comply with fresh guidelines to ensure good manufacturing practices, the central government said in a notification in the wake of complaints of substandard medicines exported from the country.

- Rhythma Kaul

Under the new Schedule M of the Drugs and Cosmetics Act of 1940, notified on December 28, a manufacturer will be held responsible for the quality of the products so that "they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy". Pharmaceutical firms will also have to intimate drug licensing authorities about recalling a drug and also report product defects, deterioration or faulty production.

The new guidelines come against the backdrop of deaths reported in certain countries such as The Gambia in Africa that were linked with consumption of Indian drugs.