September 17, 2026 1:44 PM

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Govt proposes amendments to Drugs Rules(1945) to strengthen oversight of Schedule H, H1 and X drugs

The Union Ministry of Family Welfare has proposed amendments to Drugs Rules, 1945, to strengthen regulatory oversight of Schedule H, H1 and X Drugs. These drugs require valid prescriptions for customers to purchase. The proposed amendment seeks to address concerns relating to unauthorised access to and sale of these drugs and recommends mandatory CCTV surveillance at medical stores as an additional regulatory safeguard.

 

The Ministry said, upon implementation, the proposed amendment is expected to help strengthen monitoring of the sale and distribution of these drugs and curb their unauthorised 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 within 30 days.