Drug Controller General of India (DCGI) has emphasized the need to consult the chemists and druggists associations besides consulting the state regulatory authorities before giving a concrete shape to the online pharmacy rules which is currently being reviewed by a committee of experts under the chairmanship of Maharashtra FDA commissioner Dr Harshdeep Kamble.
The committee was formed following the 48th meeting of the Drugs Consultative Committee (DCC) held on July 24, 2015 to come out with a set of norms for online companies to stay compliant. The final report is likely to come in three months time after due deliberations.
Meanwhile, All India Organisation of Chemists & Druggists (AIOCD) has also called for a complete bandh on October 14, 2015 to protest against online pharmacy.
Says Dr G N Singh, DCGI, "Drugs and Cosmetic Rules, 1945 may be subject to change based on the requirements of Indian population but the concern is that Rules meant should be in the larger interest of the patients and should not be misused. The committee of experts is working towards bringing in a set of rules to ensure that there is no misuse or abuse of drugs and devices sales via online."
The committee set up for the purpose is currently reviewing the 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.
"Though there are 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," Dr Singh explained.
DCGI formed a committee to assess the feasibility of online pharmacy following rampant online sale of prescription drugs through e-commerce companies in contravention to the law of the land. The committee is also reviewing the need to amend Rule 65 of Drugs and Cosmetic Rules 1945. 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.
As per the 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.
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.
Two types of online pharmacy models exist in the country wherein the patient gets 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. Under the other model, selling prescription drugs online without a prescription based on the patient's demand via a post or courier delivery sans any authorised bill.