AUTHORED BY - JEEVA THOMAS MANNANAL

With the advent of e-pharmacies supported by technological development and wider availability of the internet, healthcare service and medications consumption pattern has been transformed. These online services provide unmatched ease of access, cost savings, and increased availability of essential medications, making them particularly beneficial for people living in remote, rural, or underserved areas. The rise of e-pharmacies has made it so much easier for patients to order medications right from home, often at lower prices and with a wider selection. This really boosts access to e-healthcare and how well it works overall. Plus, these platforms typically include helpful features like automatic prescription fills, refill reminders, and access to medication history, all of which improve the user experience. Yet, incredible growth of e-pharmacies has imposed a variety of challenges. Problems related to drug authenticity and quality, risk to patient safety and safeguarding of personal health information has become a serious issue. Furthermore, the digitality of e-pharmacies creates the potential for misuse of prescription drugs, thereby increasing concerns for drug abuse and the distribution of counterfeit or sub-standard drugs. The lack of a robust regulatory supervision facilitates the escalation of these risks leaving the consumer susceptible to fraudulent cases, substandard goods and breaches of privacy. Despite the potential to increase the accessibility and cost-effectiveness of medical care, e-pharmacies are rapidly spreading and are a potential public health and safety liability. To develop optimal use of the potential benefits of this new frontier and to address the perspectives and limitations of this new frontier, a robust regulatory apparatus is necessary. Through regulation that avoids excessive innovation, e-pharmacies in India can be ensured to improve the scene of healthcare, enhance the protection of consumer rights and maintain the standards of quality of the best possible safety.

E-pharmacies tend to adopt broad strategies instead of narrowing their focus to specific segments. Their goal is to cater to all consumers who need medications, rather than just a select few. Moreover, these online pharmacies place a higher emphasis on keeping costs low rather than building a unique brand, as most medications are largely similar, and generic options are readily available. The products found in e-pharmacies aren’t particularly special; you can find the same items in traditional pharmacies as well. In India, there are legal restrictions that restrict e-pharmacies from selling certain types of drugs. Still, the convenience of accessing these services online helps them stand out from physical pharmacies, giving e-pharmacies a competitive edge through both cost savings and unique service offerings. To start with, online pharmacies typically rely on either an inventory-based model or a platform-based model, which allows them to cut operational costs substantially. This approach helps them avoid or significantly reduce expenses associated with running a physical store, such as rent, hiring qualified staff, purchasing equipment, and local marketing efforts. Additionally, the efficiency of their online systems speeds up transaction times for customers, further trimming costs. Next, e-pharmacies generally operate on a much larger scale than local pharmacies. They frequently attract venture capital and funding, which enables them to market their services widely and offer competitive pricing—this is a common trend in e-commerce. Such funding also allows them to roll out promotional offers like free delivery or discounted medical tests. Furthermore, the marketing efforts of online pharmacies are designed to appeal to a vast customer base that extends beyond geographical limits. Throughout the COVID-19 pandemic, more people turned to online ordering as it eliminated the need to go to physical stores, wait for service, or travel to find medications. This broad reach and the ability to provide home delivery with shorter wait times have proven to be advantageous. Also, e-pharmacies benefit from economies of scale owing to their large customer base, which provides them with a significant advantage over traditional brick-and-mortar stores. They often provide extra services, such as reliable diagnostic options and detailed information on medications—including usage instructions, side effects, and precautions—usually at no cost to help educate their customers. They even offer online consultations with registered doctors for just a minimal fee. Finally, e-pharmacies can help customers save money on medical expenses by providing generic medications, which are generally more affordable than brand-name drugs found in conventional pharmacies.[1]

In India, the manufacture, sale, and distribution of pharmaceutical products are governed by several laws, such as the Drugs and Cosmetics Act of 1940, the Drugs and Cosmetics Rules established in 1945, the Pharmacy Act from 1948, the Pharmacy Practice Regulations of 2015, and the Drugs and Magic Remedies (Objectionable Advertisement) Act of 1954. A major point of discussion is whether these regulations extend to e-pharmacies. Although the Drugs and Cosmetics Act and its corresponding rules don’t explicitly mention online medicine sales, in 2015, the Office of Drugs Controller made it clear that there’s no difference in how conventional and online drug sales are treated under the DCA and DCR. This means e-pharmacies need to follow these rules just like traditional pharmacies. In 2016, the Federation of Indian Chambers of Commerce and Industry (FICCI) introduced a Self-Regulation Code of Conduct aimed at e-pharmacies, but it doesn't hold any legal power. Even with the Drugs Controller’s stance that allows e-pharmacies to operate under the Drugs and Cosmetics Act, the courts saw things differently. For instance, in 2018, the Madras High Court decided that online medicine sales couldn’t proceed until the Drugs and Cosmetics (Amendment Rules) of 2018 were formally announced. That same year, a case was brought before the Delhi High Court in Zaheer Ahmed v. Union of India[2], which sought to limit the online sale of drugs through e-pharmacies. The Court issued a temporary order banning the online sale of unlicensed medications. A similar situation occurred with the Tamil Nadu Chemists and Druggists Association v. Union of India[3], where a Single Judge ordered online pharmacies to stop selling drugs until the proposed "Draft E-pharmacy Rules, 2018" became official. E-pharmacies that operate on an inventory model appealed this decision, arguing that they were legally compliant since they possessed valid wholesale and retail licenses and their medications were dispensed by licensed pharmacists. On the other hand, marketplace-based e-pharmacies contended that they simply acted as digital platforms linking customers with authorized pharmacies, and were abiding by the Information Technology Act of 2000. The Division Bench ultimately put a hold on the Single Judge’s order, highlighting that it was the responsibility of enforcement agencies under the Drugs and Cosmetics Act to handle violations, and that an abrupt ban on online sales could adversely affect patients who rely on these services. On March 15, 2023, the Central Government let the Delhi High Court know that it was in the process of drafting guidelines to regulate e-pharmacies and asked for more time to get this done. Then, on May 22, 2023, the Delhi High Court instructed the government to provide a report in six weeks about the feedback from stakeholders concerning the draft e-pharmacy rules. The next hearing on this issue is set for August 28, 2023. This situation highlights the absence of thorough regulations concerning e-pharmacies in India. Right now, licensed e-pharmacies are operating by exploiting the vague lines between online and offline pharmacies under the DCA. Some e-pharmacies argue they’re just marketplaces, linking registered pharmacies with customers. They see themselves as intermediaries under the Information Technology Act, 2000 (IT Act), claiming they don’t need a license for selling drugs since the actual dispensing of medicines occurs at physical pharmacies. While e-pharmacies fall under the purview of the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules, it’s crucial to note that these laws were formulated before the internet became prevalent and mainly focus on drug sales through brick-and-mortar stores. They were created with the risks and challenges of traditional pharmacies in mind, not those unique to online operations. According to the Pharmacy Act 1948 and the 5Drugs and Cosmetics Rules 1945, only registered pharmacists are allowed to dispense medications based on a prescription from a doctor. With e-pharmacies, there's a significant challenge in ensuring that drugs are dispensed by a registered pharmacist. Moreover, the Pharmacy Practice Regulations, 2015, require pharmacists to advise patients on how to use medications properly, any potential side effects, and other essential information. This is a requirement that e-pharmacies might not completely fulfill. One possible way to tackle this issue could be to restrict the online sale of medicines to over-the-counter items, which don’t need a pharmacist for dispensing.[4].