Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, through Draft Gazette Notification G.S.R. 791 (E) dated 8^th September 2026, with the objective of strengthening regulatory oversight over Schedule H, H1 and X drugs.

The proposed amendment seeks to address concerns relating to unauthorized access to and sale of Schedule H, H1 and X drugs and recommends mandatory CCTV surveillance at medical stores as an additional regulatory safeguard.

The proposal was initially deliberated upon by the Drugs Consultative Committee (DCC) and was subsequently circulated among the members of the Drugs Technical Advisory Board (DTAB) for deliberation. Following consideration of the proposal, the DTAB recommended its approval.

Upon implementation, the proposed amendment is expected to help strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs and curb their unauthorized access and sale without valid prescriptions.

The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, thereby strengthening safeguards for public health.

The Ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendment. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi–110001, or emailed at drugsdiv-mohfw[at]gov[dot]in.

The e-Gazette can be accessed through the following link: https://egazette.gov.in/(S(ypsv3ntrb4ngmjg0wdnihog4))/ViewPDF.aspx

*****

SR

HFW/ Amendments to Drug Rules 1945/17 September 2026/2