Navigating the Future of E-Pharmacies: Balancing Accessibility and Regulation in India

Introduction

E-pharmacies, i.e., online pharmacies, are digital platforms that allow individuals to purchase medicines online. As smartphones became more accessible and internet access expanded, the healthcare industry quickly adapted to the broader shift toward e-commerce. Quick commerce giants like Blinkit and Zepto have popularised the establishment of ‘dark stores’ to enable delivery to consumers in a timespan of less than ten minutes. On paper, such services seem particularly advantageous for ensuring the timely delivery of medicines in urgent situations. This article examines the current legal scenario in India governing e-pharmacies and analyses whether the existing framework is adequate for a sector as sensitive and critical as medicine delivery.  

Current Regulatory Framework

The Drugs and Cosmetics Act, 1940, read together with the Drugs Rules, 1945 and the Cosmetics Rules, 2020 (collectively, “DCA Rules”) as well as the Pharmacy Act, 1948, form the core legal framework governing the licensing and sale of drugs in India. None of these laws specifically refers to e-pharmacies. In December 2015, the Office of the Drugs Controller General of India (“DCGI”)issued a notice clarifying that the DCA Rules apply to both physical and online sale of medicines, thereby bringing e-pharmacies within their scope.^[1]Specific provisions of the Information Technology Act, 2000, and the Consumer Protection (E-Commerce) Rules, 2020 (“E-Commerce Rules”), may also apply to e-pharmacies. Nonetheless, these laws are broad in scope and were not explicitly designed to address such sensitive and high-risk issues as the sale of medicines.

In the absence of explicit legal provisions, the judiciary has intervened to fill the regulatory vacuum. In December 2018, the Delhi High Court imposed an interim ban on the online sale of medicines.^[2] Around the same time, the Madras High Court also directed online platforms to suspend the sale of drugs until the Draft E-Pharmacy Rules, 2018 (“Draft Rules”), were formally notified.^[3] A Division Bench later set aside this order on appeal. In February 2023, DCGI issued show-cause notices to twenty e-pharmacies for operating without valid licenses.^[4] Although no immediate punitive action followed, these developments contributed to significant uncertainty within the sector.

Challenges and Proposals

1.        Licensing and Registration

Under the DCA Rules, there are specific licensing forms for the retail sale of drugs, but none for online market places. The Draft Rules introduced a new application, Form 18AA, for the grant of registration or renewal to exhibit, distribute, stock, and offer for sale drugs through e-pharmacies.

2.        Non-Disclosure of Information

Pharmacy Practice Regulations, 2015, prohibit pharmacists from disclosing confidential information about patient sunless required by law. Rule 67K of the Draft Rules requires e-pharmacies to provide information to State or Central government authorities for "public health purposes", although the scope of the term is not defined anywhere. While disclosure without the patient's consent is limited, there is no existing prohibition to internal use of the patient's data for profiling, target edadvertising, or algorithmically generated suggestions.

3.        Disclosure of Essential Details

Although the E-Commerce Rules specify some transparency for e-commerce companies, it may not be sufficient for a sector as sensitive as medicines and controlled substances. Rule 67M(6) of the Draft Rules proposes to address this gap by requiring the disclosure of key operational information such as registration details, pharmacist identification and credentials, drug procurement data, and grievance redressal mechanisms. Mandatory disclosure would help strengthen public trust and ensure regulatory oversight.

4.        Monitoring Provisions

Currently, there is no effective oversight framework for e‑pharmacies. This creates a significant regulatory gap, especially for inventory‑based e‑pharmacies. Rule 67-O of the Draft Rules requires in-person inspections by the Central Licensing Authority at least once every two years. These inspections would help promote and ensure consumer safety, regulatory verification, and public health assurance.

5.        Drug Abuse

Drugs listed in Schedule H, H1, and X cannot be sold without a prescription. Some of these drugs include narcotics and addictive substances, which can be harmful if misused. E-pharmacies typically require users to upload a prescription before purchasing restricted drugs. However, customers can often bypass these rules by uploading the same prescription to different platforms. Furthermore, there is no system in place to verify the authenticity of such prescriptions through digital signatures or electronic certificates.

Conclusion

The Draft Rules are a step in the right direction, but there is still scope for improvement. They were introduced in 2018 to regulate India’s expanding e-pharmacy sector, yet these rules have not been enacted for seven years. Similarly, the New Drugs, Medical Devices, and Cosmetics Bill, 2022, remains unimplemented. The lack of regulatory action is quite disappointing, especially when various court orders have stressed the need to establish a legal framework.

E-Pharmacies are a vital means of increasing access to medicines, particularly in areas with limited access to brick-and-mortar pharmacies. It is also beneficial for the elderly and people with disabilities to secure autonomous access to medications. Thus, there is no doubt that e-pharmacies are a revolutionary step in making medicines more accessible. However, without a concrete legal regime governing them, both sellers and customers are disadvantaged.

REFERENCES

[1]Central Drugs Standard Control Organization, ‘Online Sale – December 2015’(Public Notice, 2015), https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Online-Sale-dec-2015_170.pdf

[2]No online sale of medicines till norms in place says Delhi HC - The New IndianExpress (2018), https://www.newindianexpress.com/business/2018/Dec/18/no-online-sale-of-medicines-till-norms-in-place-says-delhi-hc-1913231.html

[3]Madras HC bans online sale of drugs – The Hindu (2018), https://www.thehindu.com/news/national/tamil-nadu/madras-hc-bans-online-sale-of-drugs/article25384004.ece

[4]Amazon, Flipkart among 20 e-tailors given notices for selling drugs without licence – India Today (2023), https://www.indiatoday.in/business/story/amazon-flipkart-e-tailors-given-notices-for-selling-drugs-without-licence-2333826-2023-02-12

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