New Delhi: In a fillip to e-pharmacies that are facing multiple lawsuits over their legal status, the Drug Technical Advisory Body (DTAB), the country’s highest drug advisory body on technical matters, has approved the new draft regulations proposed by the Union Health Ministry on online sale of medicines and pharmaceutical products. The DTAB has deliberated the draft rules at its recent meeting and agreed on amending the Drugs and Cosmetics Rules, 1945 to regulate online drug sales, it is learnt.
The ministry has come out with the draft rules to regulate online sale of medicines across India and provide patients accessibility to genuine drugs from authentic online portals. The rules state that no person can distribute, stock, exhibit or offer for sale of drugs through e-pharmacy portal without registration.
Multiple public interest litigations, filed by private individuals and brick-and-mortar chemists’ associations, are currently being heard in various courts in the country against the virtual drug stores who are accused of flouting norms. One December 12, the Delhi High Court had directed the Centre and the state government to restrain the online sale of medications by e-pharmacies. Earlier this year, the Madras High Court also passed an interim injunction halting online drug sales on a petition filed by the Tamil Nadu Chemists and Druggists Association (TNCDA). However, the firms received a reprieve later when the court clarified that the ban would be applicable to only unlicensed players.
While welcoming the proposed rules to regulate the segment, online pharmacy majors stress that that their business is nothing illegal, as they are only intermediaries in the supply chain. “Many e-pharmacies have licence to sell medications; some others operate online marketplaces to connect with licensed offline pharmacies. We are functioning as per the law of the land,” Amit Khanna, spokesperson of PharmEasy, a popular online drug delivery service, told Pharmabiz.
Currently, India does not have a specific legal regime for e-pharmacies and the rules governing the conventional model of pharmacy business is applicable to e-pharmacies as well. The D&C Act does not distinguish between the conventional and online sale and distribution of drugs.
The DTAB approval is expected to expedite the government move to implement the new e-pharmacy regulations. The norms focus on periodic inspections and monitoring, registration to stock and sell products and a complaint redressal mechanism.
As per the ministry’s draft notification, “any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government”. The application of registration will have to be accompanied by a sum of Rs. 50,000. An e-pharmacy registration holder will have to comply with provisions of Information Technology Act and details of patients should not be disclosed to anyone other than the central government or the state government concerned.