The sub committee set up by the Drug Controller General of India (DCGI) for regulating online pharmacy in the country is likely to discuss 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.
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. Rule on online pharmacy also needs to provide adequate safeguards and provisions with reference to Schedule H compliance in the country.
Following the 48th meeting of the Drugs Consultative Committee held on July 24, 2015, the sub-committee would come out with a set of norms for online companies to stay compliant in three months time after due deliberations.
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. Officials associated with the development say that framing rules to govern online sale of drugs should also involve studying rules in other countries on how online pharmacy is governed there. 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, the official said.
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.
DCGI formed a committee recently 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. In May this year Snapdeal had come under the fire of Maharashtra Food and Drug Administration (FDA) for selling drugs online without prescriptions.
The drug distribution is currently being regulated at the state level by the health departments for detecting such cases and taking action. Officials, however, pinpoint that there is a need for a proper regulatory mechanism for online pharmacy. This will help, according to the drug regulators, in curbing the currently prevalent illegal practice of irrational use of drugs through self-medication, more so, as it has become a global phenomena.
The committee set up for the purpose will review 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.
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.