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In a rapidly evolving digital healthcare landscape, researchers are calling for stronger regulatory frameworks to enhance consumer safety in the e-pharmacy sector in India and Kenya. A recent study by The George Institute for Global Health, in collaboration with Strathmore Business School in Kenya and the London School of Hygiene & Tropical Medicine, underscores the need for improved governance to ensure the safety and quality of medicines accessed through online platforms.
Published in PLOS Global Public Health, the study examines the strengths and gaps in the e-pharmacy sector in these two nations, where digital health services are growing significantly. Researchers emphasize the importance of a risk-based regulatory framework that fosters compliance while encouraging best practices to enhance consumer safety.
Growth and Regulation in the E-Pharmacy Market
E-pharmacies, which allow consumers to purchase prescription medicines via websites and mobile applications, are gaining traction in low- and middle-income countries. India and Kenya have witnessed significant growth in this sector, with businesses adapting to local regulatory conditions and market demands. The global e-pharmacy market, valued at USD 92 billion in 2023, is expected to exceed USD 350 billion by 2033, with India and Kenya playing a crucial role in this expansion.
Despite the sector’s growth, regulatory gaps pose challenges. India currently lacks a dedicated regulatory framework for e-pharmacies, though regulations have been proposed in the past. The study found that the most visited Indian e-pharmacy websites exhibited better adherence to best practices, meeting 62% of proposed regulatory standards compared to 51% for lesser-known websites. In contrast, Kenya has specific regulations for e-pharmacies, with platforms meeting an average of 74% of regulatory requirements.
Key Findings and Areas for Improvement
The research involved mapping e-pharmacy platforms in India and Kenya against existing regulations and international best practices. Among the notable findings:
- 90% of e-pharmacies in India and 58% in Kenya provide an option to upload prescriptions, ensuring responsible dispensing of prescription medications.
- Only 16% of Indian e-pharmacies and 42% of Kenyan e-pharmacies provide comprehensive drug information, including side effects and contraindications, highlighting a critical area for improvement.
- The e-pharmacy market expanded over a year, with the number of websites in India increasing from 61 to 76, and in Kenya from 26 to 28. Growth was driven mainly by local businesses, while some international players exited the market.
A Call for Risk-Based Regulations
To bridge existing gaps, researchers advocate for a structured, risk-based regulatory approach that balances compliance with industry growth. This involves collaboration between regulators and e-pharmacy businesses to create an ecosystem that promotes safe access to medicines. The study suggests that regulatory measures should evolve alongside digital healthcare advancements, particularly as e-pharmacy platforms increasingly integrate teleconsultation and diagnostic services.
“E-pharmacies can be great tools for improving access to medicines. However, the lack of regulation governing e-pharmacies poses risks. There is a need to create a trustworthy e-pharmacy environment in which patients can confidently access the medications they require,” said Dr. Mohammad Abdul Salam, a senior researcher and co-lead of the study.
Dr. Gautam Satheesh, research fellow at The George Institute for Global Health, emphasized the potential for e-pharmacies to become trusted sources for medication access, particularly in emerging markets where affordability and quality of medicines remain concerns. “Our research provides a foundation for policymakers to develop regulations to govern the growth of e-pharmacies and safeguard consumers,” he stated.
Looking Ahead
As the digital health sector continues to evolve, the study underscores the need for ongoing regulatory adaptation to keep pace with emerging healthcare models. With mobile applications becoming an increasingly critical access point for e-pharmacy services, particularly in India, researchers stress the importance of integrating technological advancements into regulatory policies.
Disclaimer
This article is based on independent academic research and does not constitute medical or regulatory advice. The views expressed are those of the researchers and do not necessarily reflect the positions of governing bodies. Readers are encouraged to refer to official regulatory sources for authoritative guidance.
For more details, refer to the original study: Gautam Satheesh et al, The good, the bad, and the ugly: Compliance of e-pharmacies serving India and Kenya with regulatory requirements and best practices, PLOS Global Public Health (2025). DOI: 10.1371/journal.pgph.0004202.
