Health Ministry Proposes Amendments to Drugs Rules, 1945 for Schedule H, H1 and X Drugs

The Union Health Ministry issued a draft gazette notification on 8 September 2026 proposing amendments to the Drugs Rules, 1945, with changes centred on Rule 65. The draft proposes mandatory Closed-Circuit Television surveillance at medical premises that supply prescription medicines in India.

Drugs Rules, 1945

The Drugs Rules, 1945, were framed under the Drugs and Cosmetics Act, 1940, which regulates the import, manufacture, distribution, and sale of drugs in India. Rule 65 deals with conditions for licences and sale premises for drugs, including requirements for retail and wholesale sale.

Schedule H, H1 and X Drugs

Schedule H contains prescription medicines that can be sold only on the prescription of a Registered Medical Practitioner. Schedule H1 includes selected antibiotics, anti-tuberculosis medicines, and certain habit-forming drugs, and it requires stricter record-keeping than Schedule H. Schedule X covers narcotic and psychotropic medicines with the strictest sale and storage controls under the Drugs and Cosmetics Rules.

CCTV Requirement in Medical Premises

Under the proposed amendment, medical premises supplying prescription drugs, other than wholesale dealers, would need to install and maintain CCTV systems. The recordings would have to be preserved for at least three months. The draft wording refers broadly to “any drug supplied on the prescription of a Registered Medical Practitioner”.

Regulatory Process

The proposal was examined by the Drugs Consultative Committee and then recommended by the Drugs Technical Advisory Board. The Ministry of Health and Family Welfare has invited objections and suggestions from stakeholders and the public on the draft amendment.

Important Facts for Exams

• The Drugs and Cosmetics Act, 1940, is the parent law for drug regulation in India.
• Rule 65 of the Drugs Rules, 1945, relates to conditions for sale licences and premises.
• Schedule H1 was introduced for selected medicines that require stricter sale controls than Schedule H.
• Schedule X drugs are subject to special storage, sale, and record-keeping requirements in India.

High-Alcohol Medicinal Products

In July 2026, the Union Government amended the Drugs Rules, 1945, to require doctors’ prescriptions for medicinal products containing more than 12 per cent v/v ethyl alcohol in quantities exceeding 30 mL. Such products were shifted to Schedule H1 under the amended rules.