The Uttar Pradesh Food Safety and Drug Administration (UPFDA) has cancelled license of a Ghaziabad based drug retailer Care Medical under the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1946 for illegal sale of drugs via the online mode.
This is the first of its kind case in Northern India detected by the state drug regulator where a retail drug store sold Schedule K drugs online without maintaining proper records. This comes close on the heels of online pharmacy activities currently under scrutiny for its alleged misuse as a mode for selling habit forming and abortion drugs without a valid doctor's prescription in contravention to the prevailing laws of the land.
Among the first to face the heat were online players in Maharashtra and Karnataka. However, the regulations to monitor online pharmacy is subject to review under a committee formed a few months ago under the chairmanship of Maharashtra FDA Commissioner Dr Harshdeep Kamble.
In order to come out with a set of norms for online companies to stay compliant, the committee was formed following the 48th meeting of the Drugs Consultative Committee (DCC) held on July 24, 2015. Meanwhile, All India Organisation of Chemists and Druggists (AIOCD) had also called for a complete bandh on October 14, 2015 to protest against online pharmacy.
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.
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. Says an official, "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. Rules meant for online pharmacy should be in the larger interest of the patients and should not be misused."
Though there are provisions under the Indian Penal Code and Drugs and Cosmetics Act to deal with prevalent malpractices, experts feel that there is also a need to explore other international regulatory bodies on how they are tackling the challenges in online pharmacy.
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.