The health ministry plans to leverage digital technology to create an online portal to help it regulate and plug gaps in the sale of medicines in India through various platforms, including e-pharmacies. The move is expected to ensure availability of high quality drugs to patients and could help contain the country`s growing anti-microbial resistance (AMR) problem, the ministry suggests.
India currently does not have a track-and-trace mechanism for drugs sold within the country even while it has a bar-coding system in place on packs of medicines for export. This is keeping in view concerns of the Micro, Small and Medium Enterprises industry, according to the health ministry.
"In the absence of such track and trace mechanism, having operationalised for sales within the country, complaints continue to be received by the Government about the quality of drugs," stated the ministry in a public notice on Thursday.
A recent survey on the incidence of substandard medicines in India shows that about 3% of medicines sold in the country currently are substandard.
The ministry has now proposed to establish a "robust e-enabled" structure to regulate the sales of medicines in the country through an autonomous body set up under it.
According to the proposal, the autonomous body would develop and maintain this e-platforma portal that drug makers, stockists, wholesalers, distributors, licenced chemists and e-pharmacies would have to register themselves with.
Once registered, they are expected to enter data relating to the drugs they sell, including batch numbers of the drugs, quantity supplied, returned or disposed of and expiry date of the batch. This data can be entered both through online and by using mobile phones, according to the ministry.
Details of medicines dispensed will be entered in this platform and bills would be generated through the same system including details of the prescribing doctor`s registration number, the name and registration of the chemist and the quantity supplied.
Public and private hospitals and other clinical establishments would also be required to enter details of the medicines they make available to patients, including any adverse reactions.
No retailer, chemist, e-pharmacist outlet shall be permitted to sell any medicine unless the pharmacy is registered on this e-portal, states the ministry`s proposal.
E-pharmacies, especially, wouldn`t be permitted to sell drugs unless they have a licenced brick-and-mortar facility in each of the licencing authority`s jurisdiction, it adds.
At the back-end, a system for audit by regulators has been proposed to ensure compliance with the country`s Drugs and Cosmetics Act and Rules.
"The information collected may also be used by the Ministry of Health and Family Welfare, Government of India for such purposes as considered necessary in public interest," the ministry stated in its notice.
The ministry has invited suggestions, comments and views from stakeholders and the public by April 15, 2017.