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New Regulations Proposed for Advertising Prescription Drugs in India

The Indian government has proposed new regulations that would require prior approval for advertising prescription drugs, particularly those with high abuse potential. This initiative aims to enhance control over drug marketing and ensure public safety. The draft rules, which amend existing regulations, are currently open for public feedback. The changes are expected to take effect upon final publication in the Official Gazette. This move reflects the government's commitment to regulating the pharmaceutical industry and protecting consumers from potentially harmful advertisements.
By Narendra Chaudhary | Oct 8, 2026, 21:21 IST
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Government Moves to Regulate Prescription Drug Advertisements

The Indian government has announced a new proposal aimed at regulating the advertisement of prescription medications, particularly those known for their potential for misuse and addiction. This initiative was outlined in a draft notification released by the Union health ministry on September 28, which has been published in the Gazette of India.


According to the draft, a new sub-rule will be added to Rule 65 of the Drugs Rules, 1945, stating that advertisements for drugs listed in Schedule H, Schedule H1, or Schedule X will require prior approval from the Central Government.


The proposed amendments, known as the Drugs (Amendment) Rules, 2026, will take effect once they are officially published in the Gazette. The government is currently seeking feedback and objections regarding these draft rules, allowing a 30-day window for public input following the publication.


This draft has been developed under the authority granted by the Drugs and Cosmetics Act of 1940, following consultations with the Drugs Technical Advisory Board.


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