The sub-committee, constituted by the Drug Controller General of India (DCGI) to frame regulations on online pharmacy in the country, held its first meeting recently under the chairmanship of Maharashtra Food & Drugs Administration (FDA) commissioner Dr Harshdeep Kamble.
The meet on online pharmacy following the 48th Drug Consultative Committee (DCC) meet in Delhi was a significant one as drug being an important segment in the e-commerce space, information technology advancements will help gain access to medicines in a timely manner. Recommendations on the same sought from all the state drug controllers were reviewed during the meet.
"Though there are provisions and safeguards under the Indian Penal Code and Drugs and Cosmetics Act to deal with prevalent malpractices but there is also a need to explore other international regulatory bodies on how they are tackling the challenges in online pharmacy, an official remarked.
Recommendations by state drug controllers for allowing online pharmacy also included safeguards related to selling prescription drugs online with rules to be aligned towards community pharmacists. Drug cannot be dispensed as mandated by Rule 65 of the Drugs and Cosmetics Act without a registered pharmacist.
Rule 65 stipulates sale of drug under the supervision of a registered pharmacist which also involves signing of the bill and stamping of the prescription by the pharmacist and the doctor. Rule on online pharmacy also needs adequate safeguards and provisions with reference to Schedule H compliance in the country.
Two types of online pharmacy models exist now wherein the patients get the medicine based on an indicative prescription sent online to the retail drug store so that necessary stock of prescription drug is made available to the patient timely with pharmacist authorised bill and stamp. Second type of model sell prescription drugs online without a prescription based on the patient's demand via a post or courier delivery.
As per Section 18 (c) of Drugs and Cosmetics Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 prescribes the procedure to be adopted by the medical stores while selling the prescription drugs and under which the prescription from the registered medical practitioner is necessary for sale of Schedule H drugs under the Act.
These recommendations come close on the heels of representations made by organised retail chains such as Apollo Pharmacy, Medplus and Hetero among others. In May this year Snapdeal had come under the fire of Maharashtra Food and Drug Administration (FDA) for selling drugs online without prescriptions.
The committee will consider recommendations of drug controllers of the states taking into account trade bodies, pharmacy chains and e-tailers to allow online sale of medicines as per global practices.
The domestic medicine market is growing at around 10-15 per cent a year and is estimated at around Rs.90,000 crore. Allowing online sales would also help organised retail pharmacy chains that are setting up virtual account for nearly 5 per cent of the market and are growing in double digits.