Government drafts notification to regulate advertisements of schedule G drugs

The Government of India has proposed amendments to the Drugs and Cosmetics Rules, 1945, to include regulations on the advertising of medicines containing Schedule G drugs. Schedule G drugs, which require medical supervision but do not fall under prescription-required categories, are the focus of this initiative aimed at preventing misleading advertisements. The draft notification, issued on July 10, 2024 –  invites public feedback over the next 45 days, marking a significant step in controlling the promotional activities of critical drugs.

Currently, drugs falling under Schedule H, Schedule H1, and Schedule X categories cannot be advertised without prior approval from the government. The proposed amendment seeks to extend similar controls to advertisements of Schedule G drugs, which include medications vital for managing conditions like diabetes.

The draft notification, released on July 10, 2024, invites feedback from the public, with a deadline set 45 days from the publication date. This development underscores the government’s efforts to prevent misleading advertisements that could potentially influence the use of critical drugs.

In addition to the proposed amendments, the Ministry of Health and Family Welfare highlighted existing provisions under the Drugs and Magic Remedies Act, 1954. This Act prohibits advertisements claiming to cure certain listed diseases, further emphasising the regulatory framework surrounding drug promotions.

The draft rules, published under G.S.R.375(E), propose amendments to various clauses of the Drugs and Cosmetics Rules, 1945, after consultation with the Drugs Technical Advisory Board. Interested parties are encouraged to submit objections or suggestions within the specified period to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India.

Upon the completion of the feedback period, the Central Government will review the received comments and proceed towards finalising the rules, which will then be published in the Official Gazette.

For further details, the complete draft notification is available for public viewing on the Ministry of Health and Family Welfare’s official website.