Union Health Ministry Proposes Amendments to Drugs Rules, 1945 to Strengthen Regulatory Oversight of Schedule H, H1 and X Drugs

Key Highlights:

• The Union Health Ministry has proposed amendments to the Drugs Rules, 1945.
• The objective is to strengthen regulatory oversight of Schedule H, H1 and X drugs.
• A key proposal includes mandatory CCTV surveillance at medical stores.
• This aims to curb unauthorized access and sale of these drugs without valid prescriptions.

Detailed Insights:

• The proposed amendments were issued through Draft Gazette Notification G.S.R. 791 (E) dated 8th September 2026.
• The proposal was deliberated by the Drugs Consultative Committee (DCC) and recommended by the Drugs Technical Advisory Board (DTAB).
• Implementation of these changes is expected to enhance transparency and accountability across the pharmaceutical supply chain.
• The Ministry has invited objections and suggestions from stakeholders and the public on the proposed amendments.

Key Concepts Involved:

• Drugs Rules, 1945: Regulations governing the manufacture, sale, and distribution of drugs in India.
• Schedule H, H1, X Drugs: Categories of prescription drugs requiring strict control due to potential for misuse or specific risks.
• Drugs Consultative Committee (DCC): An advisory body to the Central and State Governments on matters related to drug administration.
• Drugs Technical Advisory Board (DTAB): The highest statutory body under the Drugs and Cosmetics Act, 1940, advising on technical matters.