SHUBHAM SHARMA & NIKITA SAH
Pharmacy constitutes a scientific discipline concerned with the preparation of medicinal drugs. The term “online pharmacy” refers to e-pharmacies that operate over the internet, where sellers offer medicines online through mail, courier, or delivery personnel. The advent of e-pharmacies in India has led to heightened consumer satisfaction, contributing to an increased demand for this sector. In comparison to fully developed sectors in the U.S.A and Europe, India’s e-pharmacy industry is still in its developmental stages. Nonetheless, it has successfully established itself as an innovative concept within the Indian healthcare landscape. As a global leader in generic medicines, India’s pharmaceutical industry plays a pivotal role. The significance of e-pharmacies came to the forefront during the COVID-19 pandemic, which imposed movement restrictions. E-pharmacies played a crucial role in ensuring continuous services, working around the clock despite the risks to their workers, thereby contributing to public health.
E-pharmacy platforms facilitate the online purchase of medicines, which are then delivered to customers. In 2015, an expert committee led by Dr. Harshdeep Kamble, the then Maharashtra FDA Commissioner, was formed under the Union Health Ministry. The committee aimed to address the regulations governing online pharmacies in the country. The Union Health Ministry introduced draft regulations in August 2018 to amend the Drugs & Cosmetics (D&C) Rules, providing separate sections for governing online pharmacies. However, the implementation of these regulations has encountered delays within the regulatory process. Subsequently, the Indian Internet Pharmacy Association (IIPA) was established in the same year, comprising 11 e-pharmacy startups. These companies committed to ethical standards and adherence to existing legal frameworks, garnering support from the Indian government as part of its Digital India initiative.
According to a Frost and Sullivan Report, the e-pharmacy industry is projected to reach Rs 25,000 crore by 2022. In January 2020, the Federation of Indian Chambers of Commerce and Industry (FICCI) urged the government to finalize e-pharmacy regulations to mitigate uncertainties among stakeholders. Dr. B R Jagashetty, a sector specialist and former National Advisor (Drugs Control) for the Central Drugs Standard Control Organisation (CDSCO), emphasized the urgency for the government to expedite the finalization of e-pharmacy regulations.
Benefits and Risks of E-Pharmacies
Benefits
- E-pharmacies offer convenience and accessibility to customers.
- They extend their reach to rural areas with limited physical pharmacy shops.
- E-pharmacies often provide cost-effective options and discounts.
- Customers can access health information, including side effects, warnings, and drug interactions, along with automatic medicine reminders.
- They ensure the proper storage of cold-chain drugs requiring controlled temperatures, maintaining the effectiveness of insulin, hormones, and blood-related products.
- Additional services, such as online consultations with doctors and booking diagnostic tests, are offered, especially in metropolitan areas with nuclear families.
Risks
- Illegitimate e-pharmacies might sell substandard drugs.
- Drugs can be mishandled during transportation, affecting their quality.
- Minors can access the internet to purchase medicines without parental oversight, leading to overconsumption.
- Certain drugs require specific temperature conditions for storage; mishandling may compromise their efficacy.
- Online transactions may jeopardize customer privacy.
- E-pharmacies dispense drugs based on scanned prescriptions, which can be manipulated, potentially leading to overconsumption.
The Current Legal Framework for E-Pharmacies
The main laws governing the manufacture, sale, and distribution of pharmaceuticals in India include the Drug and Cosmetics Act, 1940; Drugs and Cosmetic Rules, 1945; Pharmacy Act, 1948; Indian Medical Act, 1956; Code of Ethics Regulations 2002; Narcotic Drug and Psychotropic Substances Act, 1985; and Drug and Magic Remedies Act, (Objectionable Advertisement) Act, 1954. The online sale of prescription-based medicines is covered under the Information Technology Act, 2000.
Several provisions within the Drugs & Cosmetics Act and Rules ensure drug quality and standards, but they do not specifically address online sales. These provisions include:
- Medicines can only be sold by registered pharmacies with valid retail licenses.
- Drugs listed under Schedule H, Schedule H1, and Schedule X of the D&C Rules can only be sold with valid prescriptions from registered medical practitioners.
- Exporting medicines is illegal as per the Government of India.
- Registered practitioners can only sell medicine upon receiving a prescription from another medical practitioner.
- Selling prescription drugs to minors is prohibited.
- Sale of banned drugs, either online or offline, is forbidden.
- Selling medicines above the maximum retail price (MRP) is a punishable offense.
Indian Pharmacy Law does not differentiate between online and offline pharmacies, although some guidelines exist within Indian Pharmacy Legislation.
According to the Drugs and Cosmetics Act and Drugs and Cosmetics Rules, all medicines can only be distributed with valid prescriptions, as mandatory for sale in India. Section 18 of the Drugs and Cosmetics Act and Rule 61 of Drugs and Cosmetics Rules, 1945 state that prescribed medicines can only be distributed by registered pharmacists mentioned in Section 42 of the Pharmacy Act, 1948.
Analysis of Draft E-Pharmacy Rules
Overview: In December 2015, the Office of Drugs Controllers General issued a notice to State and Union Territory Drug Controllers, indicating that the provisions of D&C Rules would apply to both offline and online drug sales. This notice paved the way for the issuance of pharmacy licenses. In August 2018, the Ministry of Health and Family Welfare released a draft to amend the D&C Rules, introducing a chapter on “sale of drugs by e-pharmacy.” The draft defined terms like “pharmacy,””e-pharmacy portal,” and “sale by way of e-pharmacy.” The draft also detailed the application process, conditions for registration, and procedures for distribution and sale. Restrictions on certain drugs and a complaint redressal mechanism were included.
Challenges arose through petitions filed in the Delhi and Madras High Courts, seeking to ban e-pharmacy operations due to public safety concerns. The Delhi High Court issued an interim injunction against online medicine sales, and the Madras High Court decreed a halt to online sales until the Draft E-Pharmacy Rules are notified. While the Indian government drafted these rules, they have yet to be enforced.
Registration: Starting an e-pharmacy business requires registration with the Central Licence Authority (CLA). The application, filed online using Form 18AA, is accompanied by a fee of Rs 50,000 and specified documents. The registration is valid for three years and can be renewed for a fee of Rs 50,000 within six months of expiry. Rule 67-M provides detailed registration conditions for e-pharmacies.
Distribution: Procedures for online sale and distribution of medicines include maintaining order records, procuring medications as per prescriptions, and supplying acquired drugs to customers along with receipts created through the e-pharmacy portal.
Inspection: Both the Central and State Licensing Authorities have the right to annually review data maintained by e-pharmacy registration holders. They may also request prescriptions used for dispensing drugs, and authorized officers can inspect e-pharmacy premises every two years.
Shortcomings in the Draft Rules: The Draft E-Pharmacy Rules fail to address issues such as prescription verification, validity, misuse, and dispensing. They also omit concerns about illegal pharmacies, multiple licenses, storage, and transportation. The draft does not outline the circumstances under which the government can access customer information. The concept of “public health” could infringe on customers’ Right to Privacy. The draft lacks specifications on the authority within the government that can access customer data. Additionally, it does not mandate e-pharmacies to display privacy policies on their websites or set timeframes for retaining customer information.
The Path Forward
E-pharmacies hold significant potential to address medicine accessibility and affordability issues in India. It is essential to establish regulatory mechanisms to safeguard customer interests and ensure their proper functioning. This can be achieved by introducing a strict licensing mechanism, adopting logos for verification, digital data storage, and integration with government health schemes to serve both rural and urban populations. Given the increasing reliance on e-commerce and the challenges posed by COVID-19, there’s a pressing need to enact comprehensive e-pharmacy regulations. By studying models from countries like the USA and the EU, India can effectively regulate e-pharmacies and mitigate potential risks while maximizing benefits for consumers.
(Shubham Sharma is Advocate Delhi High Court and can be reached on: [email protected]. Nikita Sah is Pharmaceutics Researcher, Uttarakhand. Email: [email protected]
