India, Sept. 17 -- image credit- freepik

The Ministry of Health and Family Welfare, Government of India has proposed to amend the Drugs Rules, 1945 to strengthen regulatory oversight on Schedule H, H1 and X drugs. The proposal was issued in the draft gazette notification GSR issued on 8th September 2026. Submitted via 791(e).

Schedule H, H1, and X drugs are prescription-only medicines in India, with H1 and X subject to stricter controls due to higher risk of misuse or adverse effects.

The proposed amendment aims to address concerns related to unauthorised access and sale of Schedule H, H1 and X drugs. It has recommended mandatory CCTV surveillance at medical stores as an additional regulatory safeguard.

The proposal was initially cons...