Satheesh Gautam, Masibo Sammy, Tiruttani Sasi Kumar, Khayoni Irene, Palafox Benjamin, Nambiar Devaki, Joseph Jaison, Kweyu Emmanuel, Salam Abdul, Wafula Francis, Goodman Catherine
The George Institute for Global Health, Hyderabad, India.
Strathmore Business School, Strathmore University, Nairobi, Kenya.
PLOS Glob Public Health. 2025 Feb 3;5(2):e0004202. doi: 10.1371/journal.pgph.0004202. eCollection 2025.
As with most technology-driven change, e-pharmacy markets have expanded faster than the pace of regulation, particularly in low- and middle-income countries. We developed and applied a checklist to assess compliance with best practices and regulations by e-pharmacies serving clients in India and Kenya, two countries with contrasting regulatory environments. We defined e-pharmacies as businesses selling prescription-only medicines directly to consumers through websites or apps. We identified the universe of e-pharmacies through online searches, and captured data using a structured questionnaire (Jan-May 2023). We then assessed e-pharmacies against a set of global 'best practice' standards, as well as national regulations (for Kenya) and 'proposed requirements' from local guidelines and draft bills (for India, which had no e-pharmacy-specific regulations). We identified 61 websites and 37 apps serving India, and 26 websites and 3 apps serving Kenya. Regarding best practices, a facility to upload prescriptions was provided by 90% of websites serving India and 58% serving Kenya. Only 16% (India) and 42% (Kenya) provided complete drug information. On average, websites serving Kenya met 8.9 of the 12 (74%) Kenyan regulatory requirements, while those serving India met 7.5 of the 14 (54%) 'proposed requirements'. Only 31% serving Kenya and none serving India displayed required registration numbers. Contrary to regulations/guidelines, many e-pharmacies serving Kenya (62%) and India (34%) listed narcotic/controlled drugs for sale. In both countries, high-traffic websites and e-pharmacies located within the study country had higher mean compliance to regulation and best practices compared to the others. These findings can be leveraged to strengthen enforcement in Kenya and inform the development of a comprehensive regulatory framework in India. We recommend a risk-based regulatory approach, where regulators work with the largely compliant ("good") e-pharmacies, improve enforcement among the partially compliant ("bad"), and eliminate the largely non-compliant ("ugly") from the market.
与大多数技术驱动的变革一样，电子药房市场的扩张速度超过了监管步伐，在低收入和中等收入国家尤其如此。我们制定并应用了一份清单，以评估在印度和肯尼亚为客户服务的电子药房对最佳实践和法规的遵守情况，这两个国家的监管环境截然不同。我们将电子药房定义为通过网站或应用程序直接向消费者销售仅凭处方购买药品的企业。我们通过在线搜索确定了电子药房的范围，并使用结构化问卷收集数据（2023年1月至5月）。然后，我们根据一套全球“最佳实践”标准、肯尼亚的国家法规以及印度当地指南和法案草案中的“拟议要求”（印度当时没有针对电子药房的特定法规）对电子药房进行评估。我们确定了为印度服务的61个网站和37个应用程序，以及为肯尼亚服务的26个网站和3个应用程序。在最佳实践方面，为印度服务的网站中有90%提供了上传处方的功能，为肯尼亚服务的网站中有58%提供了该功能。只有16%（印度）和42%（肯尼亚）提供了完整的药品信息。平均而言，为肯尼亚服务的网站符合肯尼亚12项监管要求中的8.9项（74%），而为印度服务的网站符合14项“拟议要求”中的7.5项（54%）。只有31%为肯尼亚服务的网站显示了所需的注册编号，而为印度服务的网站均未显示。与法规/指南相反，许多为肯尼亚（62%）和印度（34%）服务的电子药房列出了麻醉药品/管制药品待售。在这两个国家，与其他网站和电子药房相比，流量大的网站以及位于研究国家境内的电子药房对法规和最佳实践的平均遵守程度更高。这些发现可用于加强肯尼亚的执法力度，并为印度制定全面的监管框架提供参考。我们建议采用基于风险的监管方法，监管机构与基本合规（“好”）的电子药房合作，加强对部分合规（“坏”）的电子药房的执法，并将基本不合规（“丑”）的电子药房清除出市场。
