The government has proposed an amendment to the Drugs Rules, 1945, to strengthen regulation of advertisements relating to prescription-only medicines. The proposed amendment seeks to extend the existing requirement of prior Central Government sanction for advertising drugs specified under Schedule H, Schedule H1 and Schedule X to entities holding licences for the sale and distribution of drugs. The draft amendment has been notified by the Health and Family Welfare Ministry through Gazette Notification dated on 28th of last month following consultations with the Drugs Technical Advisory Board.

 

The Ministry said that under the existing regulatory framework, pharmaceutical manufacturers are prohibited from advertising drugs covered under Schedule H, Schedule H1 and Schedule X without prior sanction of the Central Government.

 

However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines. To address this regulatory gap, the Ministry proposed to extend the advertisement restriction to holders of licences to sell, stock, exhibit or offer for sale, or distribute drugs, including retail and wholesale drug licence holders.

 

The proposed amendment is intended to strengthen regulatory oversight across the pharmaceutical supply chain, discourage unauthorised promotion of prescription medicines and reduce risks associated with inappropriate self-medication.