Regulatory mechanisms have not kept pace with e-pharmacies' rapid growth, raising serious concerns about patient safety, privacy.
Published May 06, 2025 | 7:00 AM ⚊ Updated May 06, 2025 | 7:00 AM
Synopsis: A recent study by a Hyderabad-based research institute has revealed widespread regulatory non-compliance in India’s fast-growing e-pharmacy sector, exposing patients to potential risks such as unauthorised sales of controlled substances and inadequate drug information. Despite offering an extensive range of medicines, many platforms lack proper licensing, transparency, and safeguards required under proposed regulations.
Even as India’s e-pharmacy sector rapidly expands, it suffers from widespread non-compliance with proposed safety and regulatory standards, according to a new study by the Hyderabad-based George Institute for Global Health.
The findings raise serious concerns about patient safety, transparency, and the unauthorised sale of controlled substances.
Access to essential medicines remains a critical challenge in many low- and middle-income countries (LMICs), hindered by issues of affordability, availability, and quality.
As online retail pharmacies – once a hallmark of high-income countries – gain traction in LMICs such as India, they offer both promise and peril for healthcare systems already under strain.
“Two to three percent of total medicine sales in India are currently through e-pharmacies, a figure expected to rise to 15 percent over the next decade. Even poorer and rural communities are expected to turn to digital platforms to meet their health needs,” reads the study.
However, regulatory mechanisms have not kept pace with this rapid evolution, raising serious concerns about patient safety, data privacy, and the risk of substandard or falsified medicines.
A recent evaluation of 61 websites and 37 apps catering to Indian consumers revealed significant shortcomings in compliance with recommended practices and regulatory norms.
Despite a growing market presence, none of the Indian e-pharmacy platforms displayed the required regulatory authorisation from the Central Drugs Standard Control Organisation (CDSCO).
Shockingly, 34 percent of platforms listed narcotics or controlled substances for sale, a practice strictly prohibited without verified prescriptions.
Furthermore, 10 percent of sites likely sold prescription-only medicines (POMs) without requiring a valid prescription, exposing consumers to serious health risks.
Although 90 percent of websites allowed users to upload prescriptions, only 16.4 percent provided comprehensive drug information covering usage, side-effects, drug interactions, and contraindications.
In fact, only 57.4 percent of websites listed the intended uses of the medicines, 52.5 percent detailed side-effects, and a mere 24.6 percent mentioned drug interactions or contraindications.
These gaps in information significantly increase the risk of inappropriate medication use, especially when medicines are purchased without consultation.
Websites serving India met just 7.5 out of 14 (54 percent) proposed quality requirements, with only a small fraction displaying grievance redressal procedures (20 percent) or pharmacist credentials (3.3 percent).
High-traffic websites performed slightly better, complying with 8.7 requirements on average.
None of the websites included verifiable registration numbers, and even among the 5 percent that did, it was unclear which regulatory authority had issued them.
Most platforms also failed to provide details of the pharmacy owner or superintendent, further muddying the waters for accountability.
“None of the Indian websites displayed authorisation information from the regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), or the name and registration details of the pharmacist,” the study’s authors wrote.
“Compliance was also low for displaying a registration number (5 percent), and even for those listing a number, it was unclear which regulatory body they claimed to be registered with. Only 20 percent displayed a detailed procedure for grievance redressal, including the name and contact details of the grievance officer, which is required by Indian e-commerce regulations, though compliance with this requirement was greater among high-traffic websites (62 percent).”
Despite regulatory lapses, Indian e-pharmacies offer a broad range of products and services.
The majority listed over-the-counter (OTC) medicines (86.9 percent), nutraceuticals (85.2 percent), and traditional/complementary and alternative medicines (78.7 percent).
Complementary services such as online doctor consultations (34.4 percent) and laboratory tests (24.6 percent) were also available on some platforms.
Delivery coverage varied, with only 22.9 percent of websites offering nationwide delivery, while 32.8 percent served specific states.
A notable 21.3 percent even claimed to ship medicines internationally.
E-pharmacies had a strong digital footprint – 93.4 percent of websites and 100 percent of apps maintained a social media presence, while over 85 percent offered discounts on medicines.
Customer support features such as frequently asked questions (FAQs) were present on 63.9 percent of websites, but only 44.3 percent displayed customer reviews, suggesting limited transparency.
Moreover, a mere 13.1 percent offered multi-language support, which could pose accessibility issues in a linguistically diverse country such as India.
India’s regulatory response has lagged. Draft e-pharmacy rules have been pending since 2018, held back by safety concerns and opposition from traditional brick-and-mortar pharmacy owners.
This has sparked legal challenges aimed at banning online medicine sales altogether.
With an estimated 850,000 licensed physical pharmacies in India, the current population-to-e-pharmacy ratio stands at 21 million, indicating that the online model is still in its infancy but poised for rapid growth.
“The compliance of e-pharmacies with regulations and ‘proposed requirements’ in India was low. The practices raise important risks for patient safety and public health. Selling POMs without the authorisation of a physician can have harmful consequences when medicines are used incorrectly. In the case of antibiotics, resulting overuse may lead to the selection and spread of antimicrobial resistance,” the study’s authors wrote.
“Other common areas of non-compliance included failure to display contact information, and policies on grievance redressal or privacy. A particular concern was the lack of information displayed on medicine side-effects, drug interactions, indications, and contraindications. Better information provision was reported in a review of 100 e-pharmacy websites across 17 countries (including India), which found only 27 percent failed to provide information on side-effects, and 38 percent on contraindications.”
(Edited by Dese Gowda)
