Centre mulls regulations, action against e-pharmacies

The Union Health Ministry may take strong regulatory action against e-pharmacies following concerns over data privacy and malpractices in the sale of medicines online.

A critical report from a group of parliamentarians that reviewed the sector may also aid the ministry in taking such a step as the government plans to replace an umbrella law that governs the manufacture and sale of medicines in India in the last eight decades.

"The ministry mulls 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,” PTI reported quoting official sources.

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India's e-pharmacy market was valued at $345 million in 2021, according to a KPMG-FICCI report, which also reported 40-45% annual growth due to the spread of internet and mobile connectivity, and big investments from national and global players.

Despite such high growth, there are concerns about the functioning of e-pharmacies that are now under the government's scrutiny.

The other areas being probed by the ministry are the irrational use of prescription drugs and safe-keeping of patient medical data that are private in nature. For instance, online pharmacies collect area-wise data related to the consumption of medicines which increases the risks involved with patient safety.

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

The Drugs Controller General of India (DCGI) had in February issued show-cause notices to 20 e-pharmacies, including Tata 1mg, Amazon, Flipkart, NetMeds, MediBuddy, Practo, and Apollo over the sale of drugs in alleged violation of norms.

The notice stated that the DCGI had forwarded the order to all states 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," it said.

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Another hint comes from the ministry's decision to drop a key provision from the revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, that has been sent for inter-ministerial consultation.

The draft bill that was released in last July to seek feedback contained a provision for companies to take permission to operate an e-pharmacy. It 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. The provision in the new bill states, "The central government may regulate, restrict or prohibit the sale or distribution of any drug by online mode, by notification."