Indian Government invites comments to regulate e-pharmacies
The online pharmacy business is currently estimated to be worth Rupees 3000 crores (approx US $ 400 million) and sales are growing 100 per cent every year. E-pharmacies have been lobbying with the government to acknowledge online pharmacy sector and create structured framework for conducting business.
The Indian Government through Ministry of Health and Family Welfare notified draft rules on 28th August 2018 to streamline sales through e-pharmacies in India and has invited comments from the public within 45 days. The changes will be incorporated by making amendment to the existing Drugs and Cosmetic Rules, 1945.
The salient features of the notification are as follows:
- An application for registration of e-pharmacy along with prescribed fee of Rupees 50,000 (US$ 985) shall be submitted online to Central Licensing Authority.
- The Central Licensing Authority will then scrutinize the application submitted and grant registration to the Applicant or reject application within 30 days or direct the applicant to rectify deficiencies in the application submitted.
- The registration of e-pharmacy is valid for 3 years from the date of grant and can be renewed on payment of prescribed fee of Rupees 50,000 (US$ 985). The registration will lapse if renewal request is not filed within 6 months after the expiration date.
- The Central Licensing Authority has powers to suspend or cancel e-pharmacy registration, if the registrant contravenes provisions of Drugs and Cosmetics Act, 1940.
- An applicant aggrieved by the decision of the Central Licensing Authority can file an appeal within 45 days of the receipt of the order with Ministry of Health and Family Welfare. The appeal shall be disposed off within 60 days’ time period.
- On receipt of the prescription, e-pharmacy registration holder shall verify details of patient, registered medical practitioner and arrange or provide drugs, as per the doctor’s prescription received from the customer.
- The supply of any drug shall be made against a cash or credit memo generated through the electronic platform and such details shall be maintained by the e-pharmacy registration holder. The details of drugs dispensed (batch no., name of manufacturer, expiry date), details of the licensee dispending the drugs, serial number, date etc. shall be mentioned on the memo. In case of prescription drugs, the customer will need to provide doctor’s prescription and it will be uploaded on the e-pharmacy portal.
- Complaint can be lodged by the customer with the State Drugs Controller if adulterated / misbranded / spurious drugs are supplied.
- The premises used for conducting e-pharmacy business will be inspected every two years by officers authorised by Central Licensing Authority or State Licensing Authority.
- Sale of narcotics, psychotropic drugs and tranquillizers by e-pharmacy is prohibited. Advertisement of drugs by e-pharmacy is not allowed.
- The e-pharmacy registration holder shall maintain confidentiality about patient’s details and will not disclose it to any person other than Central or State Government. The data stored by e-pharmacy holder containing patient’s details will be stored/ saved in India only.
- The e-pharmacy shall mention information on its website about types of drugs sold, return policy details, registration granted, constitution of the Firm, details of the registered pharmacists, logistic service provider name. The e-pharmacy registration holder shall also provide customer support and complaint redressal mechanism.
- Central or State Licensing Authority may direct e-pharmacy registration holder to provide doctor’s prescription on the basis of which the drugs have been dispensed.
The rules will come into force after their final publication in the Official Gazette.
The conventional brick and mortar pharmacies have opposed establishment of e-pharmacies fearing that deep discounts prevalent in e-commerce sector to attract customers will make their business unviable. On the other hand e-pharamcies argue that online platforms are convenient and will make medicines accessible to public including patients suffering from chronic diseases, elderly and sick.