The Union ministry of health and family welfare has proposed tighter curbs on advertising of prescription-only medicines by retailers and wholesalers, according to people familiar with the matter.
However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines. “The experts were of the opinion that there need to be stricter measures in place to dissuade people from buying prescription medicines over-the-counter. “We have been complaining about this since long against online pharmacies. They advertise huge discounts, which at times don’t even seem real.
To implement the new regulations, the health ministry has proposed an amendment to the Drugs Rules, 1945, that 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. That’s not fair, therefore, it’s a welcome move by the government,” said Rajiv Singhal, general secretary, All India Organization of Chemists and Druggists.
“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,” said the health ministry. 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, according to the ministry. The move will help to rein in misuse of drugs such as antibiotics that fuels anti-microbial resistance,” said a senior government official, requesting anonymity.
The draft amendment has been gazette notified on Friday, and the health ministry has sought response from stakeholders on its proposal that needs to be submitted within next 30 days.
