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.
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.
“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.
Schedule H drugs require a valid prescription for sale. Schedule H1 is a sub-category, where the sale must be well-documented. Schedule X includes habit-forming, psychotropic and narcotic substances.
According to the 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. However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines.
{{/usCountry}}According to the 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. However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines.
{{/usCountry}}To address this regulatory gap, the ministry has proposed the insertion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945, extending 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.
Also Read | We have the addiction medicine, but seem to lack the will
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.
The proposal follows the recommendations of the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, this year, which considered the need for appropriate provisions governing advertisements by drug sale and distribution licence holders.
“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. 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.
Also Read | Diet and exercise before drugs, WHO says in its first guideline on adolescent obesity
The brick-and-mortar pharmacy owners welcome the move.
“We have been complaining about this since long against online pharmacies. They advertise huge discounts, which at times don’t even seem real. 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 centre has lately proposed a series of amendments to the Drugs rules to curb over-the-counter sale and distribution of prescription medicines.