Union Health Ministry has released draft rules on sale of drugs by e-pharmacies to regulate online sale of medicines across India. These rules also have been proposed to ensure accessibility and availability of genuine drugs to the people across India from authentic online portals.
Key features of rules
It is mandatory for online pharmacies to register under Central Drugs Standard Control Organisation (CDSCO) and obtain trade licence applicable across India from any state government. E-pharmacies only need to take one licence in any state. They can sell drugs all over the country even if they have one licence.
E-pharmacies need to apply for grant of registration to Central Licensing Authority through online portal of Central Government. The registration issued to any person for e-pharmacy will remain valid for three years period from date of its issuance and renewal of registration will have to be done in case it wants to continue.
Registration of e-pharmacy can be suspended or cancelled if it contravenes any provision of the Drugs and Cosmetics Act, 1940. E-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000. It is mandatory for e-pharmacy to maintain keep details of patient confidential and not disclose it to any person other than Central Government or State Government concerned.
The supply of any drug shall be made against cash or credit memo generated through e-pharmacy portal and such memos shall be maintained by e-pharmacy registration holder as record. Sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs will be prohibited through these portals.
The premises from where e-pharmacy business is conducted will be inspected, every two years, by team of officers authorised by Central Licensing Authority, with or without experts in relevant field or officers authorised by the concerned State Licensing Authority.
It will be binding on e-pharmacies to deliver drugs in specific time that will be told to patient during time of purchase while the e-portals are mandatorily required to have 24/7 call centres. The e-pharmacy cannot advertise any drug on radio or television or internet or print or any other media for any purpose.