A draft amendment notified through Gazette notification G.S.R. 861(E) on September 28 proposes inserting a new sub-rule under Rule 65 to prohibit holders of licences to sell, stock, exhibit, offer for sale or distribute drugs listed under Schedules H, H1 and X from advertising these medicines without prior sanction of the Central government.
Under the existing framework, pharmaceutical manufacturers are prohibited from advertising drugs covered under these schedules without prior government approval. However, the corresponding restriction does not explicitly cover entities involved in the retail and wholesale sale and distribution of medicines. The proposed amendment seeks to extend the requirement across the drug supply chain, strengthening oversight of the promotion of prescription medicines and reducing the risk of inappropriate self-medication. The medicines covered by these schedules include drugs that require medical supervision, including certain antibiotics and psychotropic medicines. Unauthorised promotion of such medicines can encourage their use without appropriate medical advice, raising concerns over patient safety and the misuse of prescription drugs.
The Ministry has invited objections and suggestions from stakeholders and members of the public within 30 days of the date on which copies of the Gazette notification containing the draft rules are made available to the public.
The submissions received within the prescribed period will be considered by the Central government before the amendment is finalised.
