The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, aimed at strengthening regulatory oversight over the sale and distribution of Schedule H, H1 and X drugs.
The proposed changes have been notified through Draft Gazette Notification G.S.R. 791 (E) dated September 8, 2026. A key proposal is the introduction of mandatory CCTV surveillance at medical stores as an additional safeguard against the unauthorised access and sale of these drugs.
Focus on prescription drugs
Schedule H, H1 and X drugs are subject to specific regulatory controls, including restrictions on their sale without a valid prescription. The proposed amendment seeks to strengthen monitoring of their movement from pharmacies to consumers and curb sales without the required prescriptions.
The Ministry has proposed CCTV surveillance as an additional regulatory mechanism to improve transparency and accountability at medical stores.
DTAB backs proposal
The proposal was initially considered by the Drugs Consultative Committee (DCC) and was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for deliberation.
Following its consideration, the DTAB recommended approval of the proposal.
If implemented, the amendment is expected to strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs and provide an additional layer of oversight at the retail level.
The CCTV requirement could also provide regulators with a mechanism to improve accountability and traceability in the sale of controlled prescription medicines.
Stakeholders invited to respond
The Ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendment.
Objections and suggestions may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, in accordance with the draft notification.
The proposed changes will take effect only after the regulatory process, including consideration of objections and suggestions, is completed and the amendment is formally notified.