Centre Proposes Prior Approval for Advertisements of Prescription and High-Risk Drugs

New Delhi: The Union health ministry has proposed that advertisements for prescription medicines — including drugs with a high potential for abuse and addiction — should require the prior approval of the Central Government before they are issued.

The proposal is contained in a draft notification issued on September 28 and published in the Gazette of India. It seeks to insert a new sub-rule in Rule 65 of the Drugs Rules, 1945, which governs the advertising of medicines.

"No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government," the draft rules state.

The three schedules cover medicines that are already subject to strict controls on sale. Schedule H drugs can be sold only against the prescription of a registered medical practitioner. Schedule H1 covers a narrower list — including certain antibiotics and habit-forming medicines — which must be kept in a separate register, carry a warning label, and be dispensed only against a prescription that is retained by the chemist. Schedule X, the most tightly controlled of the three, applies to drugs with a high potential for abuse and requires special licensing and separate record-keeping.

Under the proposal, a manufacturer or marketer of any medicine in these categories would need clearance from the Centre before issuing an advertisement. The draft notification does not set out the procedure for seeking such approval; those details may be specified when the rules are finalised.

The proposed Drugs (Amendment) Rules, 2026, will come into force on the date of their final publication in the Official Gazette, according to the notification.

The ministry has invited objections and suggestions on the draft within 30 days from the date on which the Gazette containing the draft was made available to the public. The consultation window gives industry bodies, medical associations, consumer groups and members of the public an opportunity to respond before the rules are finalised.

The draft has been issued under the powers conferred by the Drugs and Cosmetics Act, 1940, and follows consultation with the Drugs Technical Advisory Board, the ministry's technical advisory body on drug regulation.

Advertising of medicines in India is governed by a mix of statute and self-regulation. Rule 65 of the Drugs Rules, 1945 lays down conditions on how drugs may be advertised, while the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, prohibits advertisements that make certain claims or that are misleading. The fresh sub-rule would add a distinct requirement of prior sanction specifically for the three controlled schedules.

Regulators have generally treated Schedule H1 and Schedule X drugs as categories where promotion to the general public carries particular risk, since unchecked use can contribute to antimicrobial resistance, dependence or misuse. If finalised, the proposal would place the decision on whether an advertisement may be issued with the Central Government rather than leaving it to the judgement of the manufacturer.

Officials have not indicated whether the 30-day consultation period will be extended, or when the final rules are expected to be notified. The draft rules will take effect only after they are published in their final form in the Official Gazette.