Centre notifies draft rules for e-pharmacies

The Union government has notified the draft rules which will bring e-pharmacies under the ambit of the Drugs and Cosmetics Act.

The draft rules, framed in consultation with the Drugs Technical Advisory Board, are called Drugs and Cosmetics Amendment Rules, 2017. The draft regulations make it mandatory for e-pharmacies to register their portals after obtaining approval from the Central Licensing Authority to be able to procure and supply medicines online. According to the rules, the portals can sell medicines only if the patients furnish the prescription. They are barred from selling Schedule ‘X’ drugs, tranquillizers and narcotic substances.

While e-pharmacies would be required to keep data about the prescription, drugs dispensed with and the cost, the draft rules bar them from using this data for any other purpose or disclose it to any other source except the central government when it is needed for public health purposes. These pharmacies will now have to keep a record of the name of the patients, their address, details mentioned in the prescription, the serial number of the drug, its expiry date and the quantity supplied.

In the past, concerns were raised about the qualification of people dispensing drugs through online portals. The draft rules now mandate that the portals put up details of their registration on the website. The e-pharmacies will now have to upload details of directors, partners and persons having ownership, the official logo, logistics provider, return policy of drugs, the name of the pharmacist who validates the prescription, contact details of the e-pharmacy and procedure for lodging complaints.

A team of officers constituted by the Central Licensing Authority would be responsible for inspection of the location from where the e-pharmacy operates its business. The inspection would be conducted once in two years.

Sameer Sah, Associate Partner, Khaitan and Co said, “The medicines have to be provided against prescriptions – this will definitely address self-medication on prescription drugs – but one wonders whether this will also affect OTC sales.”

He also sought to know more about the distribution. The draft rules do not elaborate on last-mile delivery and associated complications as that form a core part of the overall business, he added.

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