New Regulations Proposed to Curb Misleading Drug Advertising in India

New Delhi, October 9 (Daily Kiran) : The Ministry of Health and Family Welfare in India has proposed amendments to the Drugs Rules of 1945 to strengthen the regulation of advertisements for prescription-only medications. The proposed changes aim to extend the existing requirement for prior government approval for advertising drugs listed under Schedule H, Schedule H1, and Schedule X to entities holding licenses for the sale and distribution of these medications.

Following consultations with the Drugs Technical Advisory Board (DTAB), the draft amendment was notified through Gazette Notification GSR 861(E) on September 28, 2026.

Currently, drug manufacturers are prohibited from advertising medications in these schedules without prior approval from the central government. However, the existing provisions do not explicitly include entities involved in the retail and wholesale sale and distribution of these drugs.

To address this regulatory gap, the ministry has proposed the inclusion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945. This would extend the advertising restrictions to license holders involved in the sale, storage, display, or distribution of these drugs.

Under the proposed provisions, advertisements for drugs listed in Schedule H, Schedule H1, or Schedule X would not be permissible without prior approval from the central government.

The goal of these amendments is to enhance regulatory oversight within the drug supply chain, deter unauthorized promotion of prescription medications, and mitigate risks associated with improper self-medication.

This initiative is expected to strengthen safety measures related to medications that require appropriate medical supervision, including certain antibiotics, psychiatric drugs, and other prescription medications.

The proposal follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board held on February 16, 2026, which emphasized the need for proper provisions to regulate advertisements by drug sale and distribution license holders.

The ministry has invited objections and suggestions from stakeholders and the public within 30 days from the date of publication of the draft rules. The central government will consider these suggestions before finalizing the amendments.