In the absence of regulations, e-pharmacists go for the kill

The Drug Controller General of India (DCGI) has recently issued show cause notices to online pharmacies, including Tata 1mg, for allegedly stocking and selling drugs in contravention to the provisions of the Drugs and Cosmetics Act (D&C Act), 1940 and Drugs and Cosmetics Rules 1945. The DCGI Dr. V.G. Somani said that his office has receives representations from time to time raising concerns regarding sale of drugs through online, internet or other electronic platforms, including various mobile applications, in contravention to the provisions of the D&C Act, 1940 and Rules thereunder. Sadly, the online sale of medicines includes medicines under Schedule H, H1, and X, which are only allowed to be sold by retail under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist.

The national drug regulator further mentioned that as per regulations, the manufacturer for sale or for distribution, or sell, or stock or exhibit or offer for sale or distribute any drug is prohibited except in accordance with the conditions of a license issued for such purpose and the Rule 64 of the Drugs Rules, 1945 prescribes conditions to be satisfied before a sale license is granted, while Rule 65 prescribes the conditions of the license to be complied by the licensee. Further, Rule 62 stipulates that, if the drug is sought to be sold or stocked for sale at more than one place, a separate application is to be made to the licensing authority for grant of license. Under these norms, for sale, or stock or exhibit or offer for sale or distribution of any drug, a license is required to be obtained from the concerned State Licensing Authority and conditions have to be complied by the licensee.

It may be noted that the High Court of Delhi had on December 12, 2018 issued an injunction against online sale of medicines without licence. Following the court order, the national drug regulator had forwarded it to all the drug controllers across States and Union Territories in May and November 2019, for compliance. The order was once again forwarded to the State and UT drug regulators on February 3, 2023. But there was no desired result as, in spite of the DCGI letters, the online players were allegedly engaged in sale of medicines without valid licence. It is feared that sales on such online, internet or other electronic platforms including various mobile applications without a license have potential impact on quality of drugs and pose risk to the public health due to potential misuse of drugs through self-medication and indiscriminate use of drugs. In fact, the country’s lakhs of brick and mortar pharma traders have been vehemently opposing the online sales of drugs in the country, alleging that it is a threat to public health.

Petitions were filed in Delhi High Court and Madras High Court against online sales, questioning the lack of legal backing for such sales of pharmaceutical products in the country. Of course, the DCGI’s recent action has once again brought back the long-pending issue of lack of regulations on e-pharmacies in the country. Against this background, a new set of rules for e-pharmacy is of much significance as in the absence of clear-cut provisions in the D&C Act regarding the sale of drugs through e-pharmacies, utter confusion prevails in the country's pharmaceutical market at present. The country currently does not have a regulatory mechanism for online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well.

The D&C Act does not distinguish between conventional and online sale of drugs. There are no two opinions that e-pharmacies hold tremendous growth potential and will continue growing in India. Some of the key factors such as growing internet penetration and safe digital payments, the rise in industry investments and medicine spending, as well as government initiatives, will fuel growth of this sector.

According to a KPMG-FICCI report in 2022, the e-Pharmacy market in India is expected to grow at a higher compound annual growth rate (CAGR) of around 40-45 per cent in future, backed by the growing internet penetration, digital payments and government support.

(The author is freelance

journalist with varied experience

in different fields)