Centre proposes tighter curbs on advertising of prescription drugs
The Union Health Ministry has issued a draft amendment to the Drugs Rules, 1945, to restrict the advertising of prescription drugs by retailers and wholesalers. This initiative seeks to harmonize regulations across the entire drug supply chain to prevent the misuse of controlled substances.
Why it matters
It addresses a regulatory gap that previously only targeted manufacturers, aiming to reduce the risks associated with inappropriate self-medication.
The Union Health Ministry has proposed extending restrictions on advertisements of prescription medicines to drug retailers, wholesalers and distributors, seeking to close a regulatory gap in the Drugs Rules, 1945.
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.
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