The Union health ministry has come out with a draft proposal to amend Drugs and Cosmetics Rules, 1945 to insert Part VIB to facilitate sale of drugs by e-pharmacy.
The draft released by the ministry on April 18, 2018 proposes to insert Part VIB in D&C Rules after Rule 67H and before Part VII.
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 along with a fee of Rs. 50,000. A registration issued to e-pharmacy in Form 21AA shall remain valid for a period of three years. The premises from where the e-pharmacy business is conducted shall be inspected in every two years by a team of officers authorised by the Central Licensing Authority along with the experts.
The draft has no mention of a central server through which all online prescriptions would be routed to individual e-pharmacy portals. This was earlier proposed to prevent misuse of prescription medicines by making sure that a patient cannot use the same prescription at various e-pharmacies.
The draft said the e-pharmacy shall dispense drugs as per prescription received from patients. The e-pharmacy needs to maintain record of e-prescription of patients. The record will contain name, address, and sale licence number of the licencees who is dispensing the drugs mentioned in the prescription, name of the drug, quantity, date of expiry, name of manufacturer etc.
The e-pharmacy shall not distribute drugs covered under the categories of the narcotic and psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985, tranquilizers and Schedule X drugs.
An e-pharmacy shall comply with provisions of Information Technology Act, 2000 and rules made thereunder, the Narcotics Drugs and Psychotropic Substances Act, 1985 and Drugs and Cosmetics Rules, 1945. The e-pharmacy portal shall be established in India through which they are conducting business of e-pharmacy and shall keep the data generated through the portal in India. The patient data shall be kept confidential and can be shared with the government for public health purposes.
The e-pharmacy will require to put in place a facility for customer support and grievance redressal of all stakeholders which shall run not less than 12 hours for all seven days of a week.
No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.
In the event of suspicion of supply of a not of standard quality or adulterated or misbranded or spurious drug through e-pharmacy to any customer, that customer may file a complaint in writing to the concerned State Drugs Controller, by whatever name called, in that State. Besides this, the customer has a right to seek relief under the Consumer Protection Act, 1985 and rules made thereunder.
For monitoring of e-pharmacy, the draft says the e-pharmacy shall maintain and update, from time to time, the information regarding the drugs availability, types of drugs offered for sale, supply channels or vendor lists, details of physicists, registered medical practitioner, (if any) and any other requirements of the Drugs and Cosmetics Rules on the e-pharmacy portal.
The Central Licensing Authority and the State Licensing Authority shall monitor the data or information as referred to in sub-rule (1), periodically to ensure compliance with the provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder.
In case of violations, the regulator can suspend and even cancel registration licences of e-pharmacies after giving them an opportunity to show cause as to why such an order should not be passed against them, says the draft.