Centre Moves to Tighten Advertising Rules for Prescription Drugs

The Central Government has proposed stricter regulations on the promotion of prescription medicines, seeking to bring retail and wholesale drug sellers under the existing restrictions on pharmaceutical advertisements.

The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945, through a Gazette notification dated September 28, following consultations with the Drugs Technical Advisory Board.

Under the current rules, pharmaceutical manufacturers cannot advertise medicines listed under Schedules H, H1 and X without obtaining prior approval from the Central Government. These categories cover prescription-only drugs that require controlled use and appropriate medical supervision.

However, the existing provisions do not explicitly extend the same advertising restrictions to businesses involved in the retail and wholesale sale and distribution of these medicines.

To close this regulatory gap, the proposed amendment seeks to include licence holders authorised to sell, stock, display, offer for sale or distribute drugs. This would bring retail pharmacies, wholesalers and other licensed drug distributors within the scope of the proposed restrictions.

The move aims to strengthen monitoring of drug promotions across the pharmaceutical supply chain and prevent unauthorised advertisements that could encourage people to use prescription medicines without consulting qualified medical professionals.

If implemented, the amendment could expand regulatory oversight beyond manufacturers and reinforce safeguards against inappropriate self-medication and the misuse of prescription drugs.