Govt Proposes Prior Approval for Ads of Schedule H, H1 and X Drugs

The government has proposed making prior approval from the Centre mandatory for advertisements of prescription medicines classified under Schedules H, H1 and X, including drugs with a high potential for abuse and addiction.

The Union Health Ministry, in a draft notification issued on September 28 and published in the Gazette of India, has proposed an amendment to the Drugs Rules, 1945, to introduce the requirement.

The proposed amendment seeks to insert a new sub-rule under Rule 65, stating that no advertisement of drugs specified in Schedules H, H1 or X can be issued without the previous sanction of the Central Government.

The move would bring advertisements for these categories of medicines under a prior-approval mechanism, subjecting them to scrutiny before they can be publicised. 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 from stakeholders and members of the public on the draft rules within 30 days from the date the Gazette containing the draft was made available to the public. The consultation process will allow interested parties to submit their views before the government finalises the proposed amendment.

The draft rules have been issued under the powers conferred by the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board, the notification stated.

Schedules H, H1 and X cover categories of prescription medicines subject to regulatory controls under the Drugs Rules. Schedule X includes certain medicines subject to stricter requirements, while Schedule H1 prescribes additional controls for specified drugs.

The proposal remains at the draft stage, and the prior-approval requirement will become effective only after the amended rules are formally notified in the Official Gazette. The ministry's proposal forms part of the regulatory framework governing the sale and promotion of prescription medicines in India.