On August 28, 2018, the Central Government proposed ePharmacy draft rules under Drugs and Cosmetics Act 1945 (the Act). The draft rules are proposed to regulate the online sale of medicine or ePharmacy business in India1. The draft rules define "e-pharmacy" as a business of distribution or sale, stock, exhibit or offer for sale of drugs through web portal or any other electronic mode. The draft rules also provide for various regulatory processes that would be required to operate ePharmacy business including:
Registration of ePharmacy stores
According to the draft Rule no person shall distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered under Central Licensing Authority in Form 18AA through the online portal of the Central Drugs Standard Control Organization (CDSCO). The applicant also needs to pay an application fee of fifty thousand rupees which shall be accompanied with the application form. In additiont to the e-pharmacy registration, the registration holder will have to comply with certain other conditions:
- The e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000) and Rules made thereunder.
- The e-pharmacy registration holder shall receive the orders for retail sale through e-pharmacy portal.
- The e-pharmacy registration holder shall arrange or provide the drugs, as per the prescription received from the customer, within the period specified by the e-pharmacy registration holder at the time of placement of the order through e-pharmacy portal.
- 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 record.
- The e-pharmacy registration holder shall have a facility for customer support and grievance redressal of all stakeholders which shall run not less than twelve hours for all seven days of a week;
provided, that the facility for customer support shall have registered pharmacist in place to answer the queries of customers through such customer helpline.
The registration issued to any person for e-pharmacy in Form 21AA 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 before its expiry in case the entity wants to continue.
Data privacy through e-pharmacy portal
The data of patient received through e-pharmacy portal shall be kept confidential and shall not be disclosed to any other person except to the central government or the concerned state government, in case required for public health purposes. The draft also suggests that in no case the data generated or mirrored through e-pharmacy portal shall be sent or stored, by any means, outside India.
Narcotic and psychotropic drugs sale through e-pharmacy
The e-pharmacy registration holder shall not carry out e-pharmacy activities with respect to the drugs covered under the narcotic and psychotropic categories as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), tranquilizers and other drugs as specified in the Schedule X of Drugs and Cosmetics Rules, 1945.
The draft envisages that no e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose as per the Drugs and Cosmetics Act, 1940.
Periodic inspection and monitoring
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 Central Licensing Authority and the State Licensing Authority shall monitor the data or information of ePharmacy periodically to ensure compliance with the provisions of the Drugs and Cosmetics Act, 1940, and Rules thereunder. Further, the Central Licensing Authority or State Licensing Authority, as the case may be, at any time, may direct any e-pharmacy registration holder to provide prescriptions on the basis of which the drugs have been dispensed for the purpose of transaction audit.
Note- Where the e-pharmacy registration holder contravenes any provision of the Drugs and Cosmetics Act, 1940, and this Rule, the Central Licensing Authority, shall, after giving the e-pharmacy registration holder an opportunity to be heard, shall, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary or cancel the registration.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.