The Drugs Controller General of India (DCGI) initiated fresh consultations on draft regulations for epharmacies this week, responding to a directive from the Delhi High Court. The regulator convened discussions with industry stakeholders to address concerns and outline potential solutions.
DCGI Key Players Participate in Consultations
According to an ET report, the DCGI hosted a meeting. Prominent entities like All India Organization of Chemists and Druggists (AIOCD), Pharmacy Council of India, and leading online pharmacy platforms such as Tata 1mg, PharmEasy, Netmed, and Practo took part in the meeting.
High Court’s Call for Engagement
Delhi HC gave the Centre a six-week window to inform the court about the outcomes of discussions with epharmacy stakeholders. The court’s focus on the issue stems from petitions seeking a ban on unauthorized online drug sales. The court’s next session for this case is scheduled for August 28.
AIOCD Highlights Regulatory Gaps
During an extensive two-hour session, the AIOCD spotlighted a significant gap in the Drugs Act—namely, the absence of provisions for issuing licenses to epharmacies. This has been a longstanding concern raised by retail chemist associations, underlining the lack of regulatory clarity for such platforms.
DCGI Epharmacy Regulation Landscape
The government introduced the draft New Drugs, Medical Devices, and Cosmetics Bill, 2022 last year, with the intention of encompassing epharmacies within its scope. The draft bill mandates that online pharmacies obtain licenses to continue operations. It also outlines measures to further regulate epharmacies and restrict the sale of medical devices without proper licenses.
Moreover, the health ministry is currently revising the draft bill and soliciting inputs from various departments to ensure a comprehensive regulatory framework.
In February, the DCGI issued notices to 20 epharmacy entities. Well-known names like Tata 1mg, Amazon, and Flipkart were among them. Accusers accused them of contravening provisions of the Drugs and Cosmetics Act, 1940. The accusation was related to the inappropriate selling and distribution of drugs.
A parliamentary standing committee on commerce has urged the Ministry of Health and Family Welfare (MoHFW) to speed up the implementation of draft epharmacy rules. Additionally, the committee has called for the creation of comprehensive guidelines for online pharmacy and health platforms.
A report from Research and Markets reveals that the Indian online pharmacy market’s value reached INR 25.50 billion in 2021. The sector is projected to experience a compound annual growth rate (CAGR) of 22.20%, potentially reaching INR 89.47 billion by 2027. This robust growth reflects the evolving landscape of pharmaceutical commerce in India.
