Health Ministry releases draft rules on sale of drugs by e-pharmacies

The Union Health Ministry on September 1, 2018 released draft rules on sale of drugs by e-pharmacies to regulate online sale of medicines across the country. The draft rules on “sale of drugs by e-pharmacy” state that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered.

Key Highlights:-

1. The rules state that any person who intends to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority through the online portal of the Central Government.
2. The application of registration of e-pharmacy will have to be accompanied by a sum of Rs 50,000.
3. The e-pharmacy holder will have to adhere to provisions of the Information Technology Act.
4. The rules also propose that those who want to do online pharmacy will have to register with the Central Drugs Standard Control Organization(CDSCO), the country’s apex drug regulator and central licensing authority.
5. The rules also state that the premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorised by the Central Licensing Authority, with or without the experts in the relevant field or the officers authorised by the concerned State Licensing Authority.
6. The rules also state that the registration issued to any person for e-pharmacy will remain valid for a period of three years from the date of its issuance and a renewal of registration will have to be done in case they want to continue.

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