MUMBAI: In order to ensure that drugs meet quality standards, the union health ministry could create a digital platform to track and regulate their sale in the country. A notice posted on the ministry’s website announced that the move is aimed to make the entire trade channel, from manufacturers to wholesalers/retailers to the patients, including e-pharmacies, more transparent.
This “track and trace” mechanism could also curb anti-microbial resistance (AMR) and regulate supply of medicines through the internet to persons in and outside India. Currently, bar-coding on medicine packs are done only for exports whereas the drugs sold in the domestic market are not subjected to quality checks.
A recent survey had revealed that around 3% of the drugs sold in India are substandard. According to the notice, all drug manufacturers would be required to register themselves with the portal, and enter data relating to sale with details of batch number, quantity supplied and expiry date.
All stockists/wholesalers will also be required to register and enter details of stocks received and supplied by them to further distributors or retailers. The data could be entered online or through mobile phones and pharmacies located in remote areas will have the option to upload the data once every fortnight. The notice further adds that medicines will be dispensed only against a prescription of a registered medical practitioner, with the doctor’s registration number (MCI/ state medical council).
The government is expected to finalise the guidelines under the Drugs and Cosmetics Act, 1940 by April 15. “The move is a good initiative to drive better compliance, transparency and adherence to drug guidelines. As regards the implication of cost for companies, we are awaiting the details of the proposed guidelines,” A Vaidheesh, MD GlaxoSmithKline Pharmaceuticals & VP South Asia, told TOI.