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PR_INDIA_Reg_Now_May_2023

BRING REGULATION ON E-PHARMACY

Ramesh Shankar
Thursday, March 30, 2023, 08:00 Hrs  [IST]

The Union Health Ministry has recently issued show cause notices to 20 e-pharmacy operators including Tata 1mg, Amazone and Flipkart for allegedly stocking and selling of drugs in contravention to the provisions of the Drugs and Cosmetics Act (D&C Act), 1940 and Drugs and Cosmetics Rules 1945. In the show cause notice, the Drugs Controller General of India has mentioned that his office has been receiving various representations from time to time raising concerns regarding sale of drugs through online, internet or other electronic platforms including various mobile applications, in contravention to the provisions of the D&C Act. The national drug regulator further stated in the show cause notice that the alleged online sale of medicines by these e-pharmacy players included such medicines which are classified as Schedule H, H1, and X drugs and these medicines can be sold by the retail pharmacies under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist. As the country presently does not have a regulatory mechanism for online sale of drugs, the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. The D&C Act does not distinguish between conventional and online sale of drugs. As per Section 18(c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 stipulates sale of drugs under the supervision of a registered pharmacist which also involves signing of the bill and stamping of the prescription by the pharmacist and the doctor.

Of course, the DCGI’s recent action in this regard has triggered debate on the long pending issue of bringing some comprehensive guideline for the e-pharmacy or e-health platforms by the government without further delay. As the existing laws are vague on the issue of selling of drugs through online platforms, there are reports of rampant sale of prescription drugs, including Schedule H, H1, and X drugs, by the e-pharmacies in contravention to the prevailing laws of the country. It is true that the scope for e-commerce in the pharmaceutical industry is immense and if properly regulated, online pharmacies in India could prove beneficial to various stakeholders. The scope of the sector can be gauged from the fact that the nation’s e-pharmacy market at present is brimming with activity with the entry of billionaires like Jeff Bezos and Mukesh Ambani in the fledgling sector. According to a report by KPMG in December, 2021, the Indian e-pharmacy market, with around 50 e-pharmacies and accounted for 14 per cent share of the total revenue of e-pharmacies in the Asia Pacific Region in 2020, is expected to grow at a higher CAGR of around 40-45 per cent as compared to the global e-pharmacy markets that are expected to increase at a CAGR of around 15-20 per cent. Medicine spending in India is expected to grow between 9-12 per cent over the next five years. However, there is a serious need for framing the laws within India, as the online pharmacy laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. In the absence of regulatory guidelines, there is always a threat and possibility for supplying illegal or unethical medicines or outdated, substituted, or counterfeit medications to the person who ordered the drug through these online platforms instead of the real medication. Mere issuing of show cause notices will not be sufficient. In view of the potential harm it can cause to the health of the end user in case of misuse, stringent regulation to govern the e-pharmacy sector in the country is essential.

 
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