Union Health Ministry is reported to have decided to establish an e-enabled structure for regulating sale of all types of medicines sold in the country. The objective is to ensure availability of right kind of medicine that meets the standards of quality and also to regulate the supply of medicines through online to patients. For this the ministry proposes to develop an electronic platform which will be developed and maintained by an autonomous body. All pharma companies will be required to register themselves with this portal and enter data relating to sale of drugs on the e-platform to distributors, stockists and wholesalers with batch number, quantity supplied and expiry date of the batch. All stockists and wholesalers will be required to enter details of stocks received and supplied by them to further distributors or retailers. The retail chemists located in rural or remote areas need to upload data either through mobile phones or through internet at least once every fortnight. No retailer shall be permitted to sell any medicine unless such pharmacy is registered on the e-portal. The retailers or e-pharmacy outlets will be required to enter all details of the medicines received, sold, returned to the manufacturer or disposed of in any other manner. Under the proposed structure, no sale by e-pharmacies will be allowed unless it has a licensed brick and mortar facility in each of the licensing authority’s jurisdiction. No sale of drugs shall be permitted outside the area for which a license has been issued. A transaction fee of not more than 1 per cent of the total cost of medicines subject to a ceiling of Rs.200 per prescription may have to be paid by pharmacies and e-pharmacies besides a registration fee and renewal fee to be determined by the Government from time to time.
The initiative is part of the government efforts to ensure supply of quality drugs in the country thereby curbing anti-microbial resistance as well as regulate sale of medicines through internet to persons or entities abroad. Now, the health ministry has invited suggestions and comments from the stakeholders and public by April 15 before taking a final decision on this project. The national trade body, All India Organisation of Chemists & Druggists, has already objected to the health ministry's proposal on the ground that the move is irrational and impractical in the wake of inadequate IT infrastructure in the country. AIOCD points out that it is almost impossible for retailers and stockists in remote and rural areas with limited or no internet connection to upload data related to every drug received, sold, returned to manufacturers by using mobile phones. A stockist sells more than 60,000 drug brands and are dealing with several retailers. Uploading every prescription on the portal and pay 1 per cent of total cost of medicine subject to ceiling of Rs. 200 per prescription is also not acceptable to the members of the trade. For the trade especially for lakhs of retail chemists spread across the country, the proposed regulatory reform may be quite difficult. Perhaps, the members of the pharma trade may require more time to comply with the new system considering the fact that many of them are small operators. That is understandable. But, establishing an electronic platform for the pharma trade is certainly a laudable step as that could weed out several malpractices existing in this sector.