The Bombay High Court has directed the Maharashtra government to take steps to regulate the online sale of medicines, until a specific law or rules are enacted. A division bench of Justices Naresh Patil and S B Shukare was hearing a PIL against the online sale of medicines.
Online pharmacies in India have significantly increased due to growing E-commerce in India. An online pharmacy is an Internet-based vendor of prescription drugs, and the term encompasses both legitimate and illegitimate pharmacies.
The Government informed the High Court that it had set up an experts’ committee in the chairmanship of Foods and Drugs Administration Commissioner for regulation of sale of medicines through online portals.
The Government pleader said that the committee has invited suggestions from the people, Non-governmental organizations and pharmaceutical organisations, and after perusing them, it would issue recommendations for amendments to the Drugs and Cosmetics Act.
The High Court advised the committee to study laws of developed countries such as the United States, United Kingdom and Norway where online sale of medicines is allowed, and also of Turkey, Thailand and Korea where it is not allowed.
Online pharmacies have been increasing in India, with the rise attributed to little regulation of the industry. The Maharashtra Food and Drugs Administration (FDA) has also raided 27 online pharmacies located in Mumbai, Thane and Pune and seized drugs worth Rs. 2 Crore.
Legal status in India
Medicines can be divided into two categories – prescription and over the counter (OTC). As far as OTC drugs are concerned, there are quite a few e-retailers in the market. These include Healthkart, Healthgenie, etc.
The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling and bar coding.
It appears that electronic prescriptions should be valid especially in the light of the Pharmacy Practise Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these regulations, “Prescription” is defined by regulation 2 (j)[3] ‘means a written or electronic direction from a Registered Medical Practitioner’.
On basis of existing regulations it appears that a scanned copy of prescription will be perfectly considered as a valid prescription. However, whether such electronic prescriptions can be used to buy medicine from online pharmacies has been questioned.
The Union government is considering the possibility of sale of medicines online. Medical retailers like Apollo, MedPlus and Hetoro have made requests that have prompted the government to consider modifying the Drugs and Cosmetics Act. Possible changes in the Act will permit online sale of medicines.
The process has begun with a subcommittee studying the issue. The Drugs Control General of India has appointed the subcommittee, headed by the commissioner of Maharashtra Food and Drug Administration (FDA), Harshadeep Kamble.
