Epharmacy Draft Rules: DCGI Holds Fresh Consultations With Tata 1mg, PharmEasy, Others

The Drugs Controller General of India (DCGI) conducted fresh consultations on draft regulations for epharmacies with industry stakeholders earlier this week after the Delhi High Court asked the regulator to inform it of the outcome of the deliberations.

All India Organization of Chemists and Druggists (AIOCD), representatives from the Pharmacy Council of India and online pharmacy platforms, including Tata 1mg, PharmEasy, Netmed, and Practo, attended the meeting conducted by the DCGI, ET reported.

While hearing petitions seeking a ban on “unlawful” sales of drugs online, the HC had given the Centre a time of six weeks to apprise it regarding the deliberations with epharmacy stakeholders. The court scheduled the next hearing in the case for August 28.

For a long time now, retail chemist associations have been expressing their concerns over the sale of medicines through epharmacies, highlighting that currently there are no regulations for these platforms.

During its extensive two-hour deliberation on Thursday, the AIOCD highlighted the absence of provisions in the Drugs Act for issuance of licences to epharmacies.

Last year, the government came out with the draft New Drugs, Medical Devices and Cosmetics Bill, 2022. The Bill sought to bring 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 now reportedly working on the revised draft of the bill and seeking inputs from other departments as well.

In February, the 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.

Earlier in March, a parliamentary standing committee on commerce 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.

According to a report by Research and Markets, the Indian online pharmacy market was estimated at INR 25.50 Bn in 2021 and expected to expand at a compound annual growth rate (CAGR) of 22.20% to reach a size of INR 89.47 Bn by 2027.

India’s healthtech segment has more than 5,000 startups which raised nearly $6 Bn between 2014 and November 29, 2022. Of this, online pharmacy startups raised $1.25 Bn, according to Inc42 data.