India’s health ministry is proposing a mandatory online system to monitor the supply and sale of drugs.
The Central Drugs Standard Control Organization, part of the Ministry of Health and Family Welfare (MHFW), has developed the system to ensure medication meets required standards, to regulate the sale of medicines online and to help control the spread of drug-resistant microbes.
It is estimated that one fifth of drugs manufactured in India may be fake, although recent government research puts the figure lower.
The proposed system aims to address public complaints made to the government about the quality of drugs in the country and the “need for plugging the gaps” in the online sale of drugs.
Barcoding is currently used for exported drugs but there is no mandatory system for tracking drugs domestically through the supply chain. Under the proposed system every part of the supply chain would have to report on the drugs it handles.
Manufacturers would be required to register with the e-platform and provide information on the drugs they sell to distributors and wholesalers, including batch numbers, quantities and expiry dates. Stockists, wholesalers and other distributors would also need to register and provide details on stock received. They would be required to account for all medication – whether it is sold, returned to the distributor or disposed of in other ways.
No outlet would be allowed to sell without being registered to the system, and no online retailer would be allowed to sell unless it has a registered bricks-and-mortar facility.
According to the MHFW, the proposed system would work on mobile devices and pharmacies in rural locations would be allowed to update fortnightly.
MHFW is consulting on the proposals and is currently asking for submissions from stakeholders.
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