Health Ministry to Crack Down on Prescription Drug Advertisements; Ban to Extend to Retailers and Wholesalers
The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, extending the ban on advertising Schedule H, H1, and X drugs to include retail and wholesale vendors.
The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to further tighten the regulation of advertisements for prescription medicines. Through this proposed amendment, the government aims to extend the requirement for prior central government approval for advertising drugs falling under Schedule H, Schedule H1, and Schedule X to include drug sellers, wholesalers, and entities holding distribution licenses.
Following consultations with the Drugs Technical Advisory Board (DTAB), this draft amendment was notified on September 28, 2026, via Gazette notification GSR 861 (E). Under the current regulatory framework, drug manufacturers are required to obtain permission from the central government to advertise these specific categories of medicines, but entities engaged in retail and wholesale sales were not explicitly included in this scope.
To close this legal loophole, the ministry has proposed the inclusion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945. Once implemented, no person or entity holding a license for the sale, storage, display, or distribution of drugs will be permitted to advertise Schedule H, H1, or X medicines without the prior approval of the central government.
According to the ministry, the primary objective of this move is to enhance regulatory oversight within the drug supply chain and prevent the unauthorized promotion of medicines prescribed by physicians. This is expected to reduce the risks associated with self-medication and strengthen public health safety measures. This is particularly critical for medicines including antibiotics and psychiatric drugs, which must only be taken under proper medical supervision.
This proposal is based on the recommendations of the 93rd meeting of the Drugs Technical Advisory Board held on February 16, 2026. The ministry has invited objections and suggestions on this draft from stakeholders and the general public, which can be submitted within 30 days from the date the Gazette copies become public. The central government will finalize the amendment after considering these suggestions.
