A Parliamentary standing committee on commerce has recommended the Ministry of Health and Family Welfare (MoHFW) to finalise and implement the draft epharmacy rules without further delay and formulate comprehensive guidelines with regard to the online pharmacy and health platforms.

The committee, headed by the Member of Parliament Dr Abhishek Manu Singhvi, while tabling its 176th report on the actions taken by the government on its previous report on ‘Promotion and Regulation of E-commerce in India’, said it was ‘appalled’ that the draft epharmacy rules had not been finalised till date.

“Undue delay in adopting a definitive regulatory framework results in uncertainty which is not conducive for the fast-paced digital markets,” the committee said.

It also expressed concern at the possible misuse of epharmacies for the distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications amid the absence of regulations.

“The Committee, therefore, recommends that a comprehensive guideline that encompasses the due diligence measures to be undertaken by the e-pharmacy/e-health platforms, mandatory registration with the appropriate authority for the sale of drugs, assigning responsibility on such platforms for the sale of genuine drugs, regulating the sale of controlled drugs, etc., should be formulated in consultation with the stakeholders,” the report added.

Last year, the government came out with the draft New Drugs, Medical Devices and Cosmetics Bill, 2022. The Bill also brought epharmacies under its ambit.

As per Section 41(2) of the draft Bill, online pharmacies will have to acquire a licence to continue operating as usual. The draft bill also includes suggestions for regulating epharmacies further. Online pharmacies would also not be permitted to sell medical devices without a licence if the bill becomes law.

However, the health ministry is reportedly working on the revised draft of the Bill and seeking inputs from other departments as well. Under the revised draft, the government is looking to include a clause to “regulate, restrict or prohibit” any sale, stocking or distribution of any drug by online mode.

In February, The Drug Controller General of India (DGCI) sent show-cause notices to 20 epharmacies, including Tata 1mg, Amazon, and Flipkart, for selling and distributing drugs in contravention of provisions of the Drugs and Cosmetics Act, 1940.

Following the issuance of show-cause notices, more than a dozen online pharmacies were reportedly requesting an audience with the health ministry to explain their stance. However, they were not able to get any response.