Health Ministry proposes to bar retailers and wholesalers from advertising Schedule H, H1 and X drugs without sanction
9 October 2026
The Union Ministry of Health and Family Welfare has notified a draft amendment to the Drugs Rules, 1945, inserting sub-rule (22) under Rule 65.
The draft provides that no advertisement of drugs specified in Schedule H, Schedule H1 or Schedule X shall be made without the prior sanction of the Central Government.
The requirement already applies to manufacturers and would now extend to licence holders who sell, stock, exhibit, offer for sale or distribute such drugs.
The draft was notified as G.S.R. 861(E), dated 28 September 2026, after consultation with the Drugs Technical Advisory Board.
It follows the recommendations of the 93rd meeting of the Drugs Technical Advisory Board, held on 16 February 2026.
Objections and suggestions are invited within 30 days of the date on which copies of the Gazette are made available to the public.
The Ministry states that the aim is to curb unauthorised promotion of prescription medicines and to reduce risks from inappropriate self-medication.
In plain words
DTAB Drugs Technical Advisory Board — The statutory body that advises the Centre and States on technical matters under the drugs law.
Schedule H1 Schedule H1 of the Drugs Rules, 1945 — A list of medicines, including certain antibiotics, whose sale must be recorded in a separate register.
Schedule X Schedule X of the Drugs Rules, 1945 — A list of narcotic and psychotropic medicines needing stricter licensing and record keeping.
G.S.R. General Statutory Rules — The prefix used to number subordinate legislation published in the Gazette of India.