GG News Bureau
New Delhi, 18th Sept: The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, seeking to strengthen regulatory oversight of Schedule H, H1 and X drugs and improve monitoring of their sale.
The proposal has been issued through Draft Gazette Notification G.S.R. 791 (E) dated September 8, 2026. Among the proposed measures is mandatory CCTV surveillance at medical stores as an additional safeguard to monitor the sale and distribution of these categories of medicines.
The amendment follows deliberations by the Drugs Consultative Committee (DCC). The proposal was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB), which recommended its approval after consideration.
The Ministry said the proposed measures are intended to strengthen monitoring and help prevent unauthorised access to and sale of Schedule H, H1 and X drugs without valid prescriptions. CCTV surveillance is also proposed as a mechanism to enhance transparency and accountability in the pharmaceutical supply chain.
The proposed changes come amid regulatory concerns over the availability and sale of medicines that require prescription controls. Schedule H, H1 and X categories cover drugs subject to varying degrees of prescription and record-keeping requirements under the Drugs Rules.
The Ministry has invited objections and suggestions from stakeholders and members of the public on the draft amendment. Submissions can be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi–110001, or sent by email to the ministry’s Drugs Division.
The proposal will be subject to the applicable statutory process before any amendment is brought into force.
