Government proposes immediate suspension of manufacturing licences of substandard drugs

NEW DELHI The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to immediately suspend the manufacturing licences of drugs declared Not of Standard Quality (NSQ) on specified critical quality parameters. The government said on Wednesday (November 4, 2026) that the proposed amendments seek to enable prompt regulatory intervention upon detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen the mechanism for ensuring compliance with prescribed quality standards, in the interest of patient safety and public health. Why does India have a substandard drugs problem?

| In Focus podcast Why does India have a substandard drugs problem? | In Focus podcast The Jan Vishwas Bill, passed on July 27, sparked controversy around its amendments to the Drugs and Cosmetics Act, 1940. Prashant Reddy joins us to explain the new amendments and what they mean for the drug regulations in India.

Why does India have a substandard drugs problem?