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.
The rules aim to provide patients access to genuine drugs from authentic online portals.
Draft Rules: Key Highlights
• 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.
• The application of registration of e-pharmacy will have to be accompanied by a sum of Rs 50,000.
• The e-pharmacy holder will have to adhere to provisions of the Information Technology Act.
• 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.
• 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.
• 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.
• The draft rules specify procedures for sale through an e-pharmacy.
• The rules state on receipt of the prescription, the registered pharmacist shall verify the details of the patient, registered medical practitioner and arrange the supply of drugs.
• The details of the 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.
• The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as a record.
• Under the new rules, 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 portals will also be mandatorily required to have 24/7 call centres.
The finalisation of the draft rules will help people get genuine drugs through online pharmacies. The concerned pharmacies will be purchasing directly from the drug manufacturer so they will be able to give 20-30 per cent discounts, thus benefiting the patients.
Following this, those who wish to operate e-pharmacies, will only need to take one licence in any state to sell drugs all over the country.
• The new draft rules prohibit the sale of tranquilizers, psychotropic drugs, narcotics and habit-forming drugs through the online portals.
• The draft also prohibits the e-pharmacies from advertising any drug on radio, television, print or internet or any other media for any purpose.
• The draft also has provisions of suspension and cancellation of registration of the e-portal if the latter contravenes any provision of the Drugs and Cosmetics Act, 1940.
The Drugs and Cosmetics Act, 1940, governs the sale of medicines in India. Medicines can be sold from licensed premises only.
The Act, however, does not cover e-pharmacies at present and the government had decided to appoint a sub-committee, after receiving complaints of violations.
The draft released on September 1 is based on the sub-committee's recommendations.
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