Facilitating the modern lifestyle, technological advancements have transformed the human lives. The skill of innovation has eliminated the dependence on physical media for fulfilment of major requirements and has rather provided a virtual platform making all major services such as information, record maintenance, communication, commerce, banking available at the click of a button. Taking recourse to the digitalization, the pharma sector has also entered the e-space.
The commercial activities pertaining to drugs and medical devices in India are regulated by the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the "Act") Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the "Rules") under the authority of Central Drugs Standard Control Organisation (hereinafter referred to as "CDSCO").
With the internet being readily accessible and easy to use more and more consumers are rapidly opting to use this medium for purchasing pharmaceuticals. The web-based service providers cater to the needs of their customers based on the information provided to them. The advantages of buying the medications online are not limited to saving time and effort to go to the pharmacy but also 24-hour ordering facility, doors-step delivery and attractive discounts being offered. Some of the industrial players of this domain are Netmeds, Practo, PharmEasy, Medplus Medidart, etc.
Madras HC order
A writ petition raised by the Tamil Nadu Chemists and Druggists Association, seeking ban on the websites permitting online sale of medications listed under Schedule H, Schedule H1 and Schedule X of the Act which are to be sold only on the prescription of a Registered Medical Practitioner and not otherwise. As per the petition, such rampant sale of restricted drugs through online medium without the required prescription was violative of Regulations 65 regarding requisite licenses and 97 for labelling of medicines of the Rules.
The Madras High Court (hereinafter referred to as the "Court") vide its order dated October 31, 2018, interim injunction against the online sale of medicines without licence or the competent authority to stall such online sales.1
The aforesaid order of the Court has raised ambiguity amongst those engaged in online sale of drugs on the aspect of its applicability. The online pharmacists seek clarity if the said order deals with the business of the pharmacies trading online without license or those selling prescribed drugs without requisite prescription. 2
The prevalent law in this regard in the form of Act and Rules does not include the digital or online medium in its current form as a mode of drug distribution or sales. Although, the Government is in process of introducing guidelines for online pharmacy industry with the objective of providing a stable framework for proper regulation of commercial transactions in respect of pharmacy products, conducted via online media, lack of proper regulation in this aspect creates ambiguity amongst the business entities in this segment as well as their consumers.
The appropriate instructions by the Hon'ble Court in furtherance to their abovementioned order would enable the pharmacies and consumers to understand the position of law for online commercialization of medications until a proper legal mechanism is enforced.
1 Madras HC W.P.No.28716 of 2018 and W.M.P.No.33542 of 2018
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