The Union Ministry of Health and Family Welfare has announced a proposal to amend the Drugs Rules, 1945, aiming to strengthen regulatory oversight over certain drug categories through mandatory CCTV surveillance at medical stores. The changes are expected to improve monitoring of the sale and distribution of Schedule H, H1 and X drugs.
On September 17, 2026, the Union Ministry of Health and Family Welfare announced a proposal to amend the Drugs Rules, 1945 through Draft Gazette Notification G.S.R. 791 (E) dated 8 September 2026. The objective is to strengthen regulatory oversight over Schedule H, H1 and X drugs due to concerns about unauthorized access and sale.
The proposed amendment recommends the implementation of mandatory CCTV surveillance at medical stores as an additional regulatory safeguard. This move follows deliberations by the Drugs Consultative Committee (DCC) and approval from the Drugs Technical Advisory Board (DTAB).
According to the sources, the proposal was initially circulated among the members of the DTAB for their consideration.
Upon implementation, these changes are expected to improve monitoring of the sale and distribution of Schedule H, H1 and X drugs and curb their unauthorized access and sale without valid prescriptions. The 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
HFW/ Amendments to Drug Rules 1945/17 September 2026/2
Source:
Press Information Bureau
