Draft Rules on Sale of Drugs by E-Pharmacy
21, Sep 2018
Prelims level : Particulars of the Draft Policy Mains level : E-Commerce of Pharmaceuticals in India
Why in News?
- Ministry of health and family welfare has issued a draft notification recently on the sale of drugs by E-Pharmacies. The notification is about the amendment of Drugs and Cosmetics Rules amendment to enable registration of the e pharmacies and monitoring of their functioning.
Significance of these rules:
- With this, Rs 3000 crore online pharma business will be regularised from the day of final notification.
- These rules have been proposed to ensure accessibility and availability of drugs to the people across India.
- After the rules are finalised, people will be able to get genuine drugs through these online pharmacies.
Registration Mandatory for e-Pharmacy:
- The draft states that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered.
- Any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government.
- The Central Drugs Standard Control Organization (CDSCO), the country’s apex drug regulator and central licensing authority is the nodal agency.
- The application will have to be accompanied by a sum of Rs 50,000 while asserting that an e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000).
- The supply of any drug shall be made against cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as record.
- The registration will remain valid for a period three years from the date of its issuance and a renewal of registration will have to be done.
- The details of patient shall be kept confidential and shall not be disclosed to any person other than the central government or the state government concerned, as the case may be.
- Sale of tranquillisers, psychotropic drugs, narcotics and habit-forming drugs have been prohibited through these portals.
- 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.
- It would be binding on the e-pharmacies to deliver the drugs in the specific time that will be told to the patient during the time of purchase.
- The e-portals are mandatorily required to have 24/7 call centres.
- No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose if it contravenes any provision of the Drugs and Cosmetics Act, 1940.