Why small drug firms are facing a crackdown

The Drugs Controller General of India (DCGI) has directed states to inspect thousands of small- and medium-sized pharma firms to enforce stricter quality standards. The crackdown follows recent child deaths linked to Indian cough syrups. Mint explains:

- BY JESSICA JANI

1 What's the drug regulator's directive?

DCGI Rajeev Raghuvanshi, in a letter dated 7 November, directed state authorities to inspect manufacturing units that had applied for a one-year extension to implement the revised Schedule M, which sets good manufacturing practices (GMP) standards. Authorities will ensure that these units have upgraded their facilities and practices in keeping with the new guidelines, which take effect from 1 January 2026. For MSMEs that did not apply for an extension, DCGI has directed action if found to be non-compliant. MSMEs with an annual turnover of below *250 crore have been given an optional extension until the end of this year.

2 What is Schedule M in drug manufacturing?