Government Mulls Regulation, Crackdown on E-Pharmacies Amid Concerns Over Data Privacy, Malpractices

The Union Health Ministry is mulling regulations and stringent action against e-pharmacies, including banning them completely, following concerns over data privacy, malpractices in the sector, and irrational sale of drugs, official sources said on Monday.

The revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which has been sent for inter-ministerial consultation, states, "The central government may regulate, restrict or prohibit the sale or distribution of any drug by online mode, by notification." The New Drugs, Medical Devices and Cosmetics Bill, 2023, seeks to replace the existing Drugs and Cosmetics Act of 1940.

The draft bill which was put on the public domain in July last year seeking feedback from stakeholders contained a provision for taking permission to operate an e-pharmacy.

The old draft bill read, "No person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode (e-pharmacy) except under and in accordance with a licence or permission issued in such manner as may be prescribed." This provision has been removed and replaced in the revised draft bill.

According to official sources, regulating the functioning of such e-pharmacies, unrestrained and irrational use of prescription drugs and maintaining the privacy of patient data are major focus areas. These online pharmacies collect area-wise data related to the consumption of medicines which increases the risks involved with patient safety, a source explained.

A group of ministers had earlier stated that they were in favour of banning online pharmacies.

The Drugs Controller General of India (DCGI) in February had issued show-cause notices to 20 e-pharmacies, including Tata 1mg, Amazon, Flipkart, NetMeds, MediBuddy, Practo, and Apollo, over the online sale of drugs in alleged violation of norms. The notice stated that the DCGI had forwarded the order to all state and Union Territories in May and November 2019 and again on February 3, 2023, for necessary action and compliance.

"In spite of the same, you are found to be engaged in such activities without a licence," the notice to the online medicine sellers said.

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