Health Ministry proposes stricter advertising rules for prescription drug sellers

Key facts

• The Union Ministry of Health and Family Welfare proposed stricter rules requiring prior approval from the Central Government for advertisements of drugs listed under Schedules H, H1 and X of the Drugs Rules, 1945.
• The proposal adds sub-rule (22) to Rule 65 of the Drugs Rules, 1945, extending existing advertising restrictions, which currently apply only to pharmaceutical manufacturers, to licensed retailers, wholesalers and other entities that sell, stock, display, offer or distribute such drugs.
• The move aims to improve regulatory oversight across the pharmaceutical supply chain, curb unauthorised promotion of prescription medicines, reduce the risk of inappropriate self-medication, and strengthen safeguards for medicines requiring medical supervision such as certain antibiotics and psychotropic drugs.
• The proposal follows recommendations from the 93rd meeting of the Drugs Technical Advisory Board (DTAB) in February 2026, and stakeholders and the public have been invited to submit objections and suggestions within 30 days of the Gazette copies being made available.
• Last month, the Health Ministry also proposed mandatory CCTV surveillance at all medical stores, with recordings preserved for at least three months, to prevent unauthorised sale of Schedule H, H1 and X medicines without valid prescriptions.
• Schedule H covers more than 500 prescription-only medicines; Schedule H1 contains around 46 medicines subject to stricter monitoring, including certain third- and fourth-generation antibiotics and anti-tuberculosis drugs, with red-bordered Rx labels and mandatory record-keeping retained for at least three years; Schedule X covers certain narcotic and psychotropic drugs subject to stricter controls.