Strict action by regulatory agencies on sale of medicines online: Crisis looms on e-pharmacy business without valid license and violation of rules


The government, Central Drugs Standard Control Organization (CDSCO) and the Health Ministry are taking a tough stance on the rapidly growing digital healthcare and e-pharmacy sector in the country. Strict ban and notice action have been taken against e-pharmacy platforms that have been operating without statutory regulations and valid online licensing system for a long time. At present there is no separate statutory and codified law notified for online sale of medicines under the Drugs and Cosmetics Act, 1940 and Rules 1945. This has raised serious legal and public health concerns over the sale of scheduled drugs (Schedule H, H1 and Protest by over 8 lakh offline chemists and legal dispute Continuous protests are being lodged against e-pharmacy companies by 'All India Organization of Chemists and Druggists' (AIOCD), the largest organization of traditional medical stores and drug sellers in India. Uncontrolled discounts and impact on the market: Offline chemists allege that big e-pharmacy companies, on the basis of foreign investment, are destroying the business of local drug stores by giving huge discounts ranging from 20% to 70% (Predatory Pricing). Danger of misuse of medicines: There is a danger of narcotics, antibiotics and habit-forming drugs of depression being ordered through online medium without strict verification. Interim orders of courts: In the PILs filed in Delhi High Court and other High Courts, instructions have been given to completely ban illegal online sale of medicines and implement strict E-Pharmacy Rules. E-pharmacy companies' stand: Intermediary model and convenience for patients On the other hand, the country's major online pharmacy companies say that they act only as a digital platform or 'intermediary'. Supply from licensed retailers: The companies claim that 100% of the medicines sold by them are dispatched from local medical stores licensed by the State Food and Drug Administration (State FDA) and the bills are prepared under the supervision of registered pharmacists. Life-saving support in remote areas: Online home delivery of medicines helps the elderly, critically ill patients and people living in remote rural areas in getting affordable and authentic medicines at the comfort of their homes. Government's new draft rules: What will be the main conditions? Under the proposed regulatory framework being prepared by the Health Ministry, instead of completely stopping online medicine sales, there is a preparation to bring them under strict rules: Central Registration Mandatory: Only those e-portals will be able to sell medicines, which are registered with the Drug Controller General of India (DCGI). Complete ban on Schedule Stringent Prescription Verification: It will be mandatory to upload and maintain records of verified digital prescription of Registered Medical Practitioner (RMP) with every order. Ban on misleading advertisements: There will be a provision of strict penalty for giving exaggerated and misleading discounts and advertisements to increase the sale of medicines. Impact on e-healthcare startups and investments worth crores: Due to regulatory uncertainty and legal strictures, there has been a direct impact on the valuations and capital flows of startups working in the online healthcare and medicine delivery sector. Many companies are having to change their business model and adopt hybrid model (online + offline stores). Market experts believe that until the government finalizes and notifies the official e-pharmacy policy, legal and administrative action will continue against unauthorized platforms violating the rules.

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