India’s Drug Regulator Serves Show-Cause Notice to Online Pharmacies

India’s apex health regulatory agency, the Drug Controller General of India (DCGI), has served a show-cause notice to more than 20 top Indian e-pharmacy companies, including Amazon, Flipkart and Tata 1MG. The notice, issued by DCGI VG Somani, warned these companies of “further action” while setting a deadline of two days to respond to the notice. The reason cited for sending the showcause notice is the contravention of the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder. The move is driven by the complaint forwarded by the All India Organisation of Chemists and Druggists (AIOCD) to multiple government agencies, including the Prime Minister’s Office (PMO). AIOCD, an apex body of approximately 12 lakh offline chemists across India, had sent advance notice of nationwide agitation from February 15 against inaction by the government agencies on the illegal sale of drugs on the online platform with predatory pricing. E-pharmacy Industry officials believe that this is just a re-iteration of an old order and “nothing new”. Last week, the Union Ministry of Health and Family Welfare in Parliament said that in order to regulate the online sale of medicines comprehensively, the Government of India has published draft rules for inviting comments from public/stakeholders for amendment to the Drugs and Cosmetics Rules, 1945 for incorporating provisions relating to regulation of sale and distribution of drugs through e-pharmacy.