India’s online pharmacy boom and the perils of unregulated medicine 

Online shopping has trained us to value one thing above all others: visibility. Yet what empowers a consumer comparing prices becomes a liability when the same screen displays prescription drugs with ratings and discounts inviting us to treat medicine as a commodity, substitute a prescribed brand for a cheaper alternative or abandon a drug course because the refill seems expensive. The question worth asking is whether this visibility serves us equally well when the product in the cart is medicine or whether it turns a prescription into a shopping list inviting edits that can cost lives.  India’s e-pharmacy industry has witnessed a phenomenal growth from around $0.5 billion in 2019 to about $3.71 billion in 2025, with predictions of growing to $14.08 billion by 2034. Over-the-counter medicines currently make up about 56 per cent of sales of online pharmacies in India. E-pharmacy platforms as well as quick commerce applications providing ten minutes delivery have made medicine purchase hasslefree. This growth nevertheless has taken place in the absence of regulation; the draft of e-pharmacy regulations of 2018 is yet to be finalised after seven years and the Drugs and Cosmetics Act, 1940, dates back to pre-internet era and remains inadequate by far to meet the challenges brought forth by e-commerce in medicine.  The regulatory deficit  The Drugs and Cosmetics Act of 1940, together with the Drugs Rules of 1945 and the Pharmacy Act of 1948, forms the legal basis for regulating the sale of drugs in India. This legislative regime is predicated on the existence of a physical store and a licensed pharmacist. However, a legislation enacted in 1940 evidently does not envisage a sale taking place via a digital application.  The newer statues too fail to bridge the gap. The Information Technology Act of 2000 enables the platform to take shelter under the cover of being an intermediary; the Consumer Protection Act of 2019 addresses the transactions but not the clinical risks it entails; the Telemedicine Practice Guidelines of 2020 binds the doctor prescribing the drug but not the platform dispensing it and the Digital Personal Data Protection Act of 2023 does not designate health data as a category requiring any special protection. The draft rules containing provisions relating to registration, inspection, advertisement prohibition, grievance redressal and monitoring have still not seen the light of the day.  Judicial intervention has tried to address the risk but has not been able to make any real dent. In December 2018, for instance, the Delhi High Court placed an interim ban on the sale of medicines online, stating that it was impermissible under the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948. In November 2023, the court gave the government “one last chance to formulate a policy in eight weeks”, stressing that “more than five years have lapsed and the Union of India has had sufficient time to frame a policy”. However, as of now none has been formulated yet. The antibiotic time bomb  Nowhere is the danger of this regulatory paralysis more acute than with antibiotics. The portal through which users can search symptoms and treatments renders the need for prescription a formality. As per the cross-sectional survey conducted in 2024 among 50 Indian e-pharmacies, it has been observed that antibiotics from all three WHO AWaRe categories including “Watch” and “Reserve” antibiotics, which have relatively more resistance potential, are available for online sales. None of the portals fully complied with the safety criteria. Whereas 82 per cent of the portals demand prescription, none of the websites mentions the registration number of the pharmacist on duty and none of them has any mechanism to restrict the excessive ordering of antibiotics. The study concluded that increased access to high-risk antibiotics may translate into antibiotic misuse.  All India Organization of Chemists and Druggists has consistently expressed its concern that illegal online pharmacies are dispensing antibiotics without authorised prescriptions misusing even the telemedicine guidelines and issuing frivolous prescriptions. The Drugs Controller General of India also has flagged unchecked antibiotic sales as a major contributor to rising drug resistance.  According to 2021 figures, antibiotic resistance is thought to have been responsible for about 267,000 deaths in India alone with another 940,000 deaths indirectly related to it. Projected estimates indicate that about 1.2 million people will die annually from AMR by 2030 unless concerted action is taken with alacrity. Worldwide, it is predicted that there will be 39 million AMR-related deaths from 2025 through 2050. This highlights the pervasive extent of the issue.  The data privacy gap  In addition to the aforementioned concerns, there is another major problem with data privacy that e-pharmacies bring along. Each prescription, health history and diagnostic report uploaded constitutes a wealth of private health information. However, health information is not regarded as “sensitive personal data” in the Digital Personal Data Protection Act of 2023.  A prescription contains information about chronic ailments, mental disorders and other sensitive aspects of a patient’s health status. Without being licensed according to the Drugs and Cosmetics Act, online portals do not have any obligation to safeguard patients’ confidentiality. While the epharmacy rules in 2018 included provisions regarding data privacy, these were never enforced. Patient information provided to epharmacies is thus left in a legal limbo, without proper safeguards and protections.  In fact, when something is going wrong, a counterfeit drug, an adverse reaction or a prescription fulfilled without verification, the issue of liability remains unsettled. The epharmacies have tried to defend their stance that they do not need any license as they simply deliver drugs like food delivery applications. This argument deliberately misconstrues the nature of pharmaceutical transaction because the platform which controls the price, manages the interface and processes the payments cannot be considered only as a passive intermediary. In fact, in February 2023, more than 20 online pharmacies received show cause notice from the Drug Controller General of India (DGCI) as they were operating without any license. However, no punitive action was taken. As a result, the industry continues in legal uncertainty, with marketplaces disclaiming responsibility for the transactions they design.  Charting a safe path forward  The fix is not very complex but is certainly long overdue. What India needs is an epharmacy act that plugs several important regulatory gaps. To start with, there should be mandatory registration at the Central Licensing Authority level using a dedicated website for a specified period of time with proper verification of compliance. The draft rules proposed Form 18AA in this regard and this must be carried out immediately. Moreover, the portal must prominently display registration details, the firm’s constitution and the registered pharmacist’s name.  In addition, the Act must proovide for a reliable electronic prescription system through the Ayushman Bharat Digital Mission as opposed to accepting scanned copies of handwritten prescriptions. There should be a centralised prescription database so that the same prescription cannot be used on multiple platforms. Patient and practitioner verification must be done by registered pharmacists before dispensing any medication.  Moreover, the Digital Personal Data Protection Bill has to be modified in so as to classify health-related data including prescriptions, past medical history and diagnostic information under a specially protected category. Data localisation should be ensured in such a manner that all the data is stored only in India, with the platforms being subjected to greater data protection obligations than generic intermediaries. The liability conundrum must also be settled definitively. E-pharmacy platforms cannot escape liability as an intermediary while regulating the transaction. There should be a clear delineation of liability and its sharing between the platform, pharmacist, prescriber and manufacturer. The platforms need to be considered as active players in the pharma value chain.  Additional safeguards must include an absolute bar on online sale of narcotics, psychotropic substances and Schedule X drugs. It is also crucial to clearly prohibit advertising of prescription medicines since this kind of advertising results incentivizes self-medication among patients. Every e-pharmacy must employ a registered pharmacist available round the-clock for verifying prescriptions and answering customer questions. There should also be regular inspections of the premises in addition to risk-based transaction audits. Finally, the framework must provide for a robust grievance redressal system, a dedicated monitoring body and complete supply-chain traceability from manufacturer to patient, guarding against counterfeit medicines.  The way forward  It needs to be acknowledged that the advent of E-pharmacies in India is no passing trend. It is a radical change whose time has come. These e-commerce platforms have the potential to bring muchneeded relief to many Indians, from the bed-ridden elderly, the chronically ill to those in the rural parts of the country who have trouble finding well-stocked physical pharmacies. They can also democratise access, make prices transparent and provide convenience that is simply unachievable through brick-and-mortar outlets. Moreover, the pandemic has accelerated this process and has expanded the market and there is no turning back now.  \Yet paradoxically, the features that make e-pharmacies convenient also make them dangerous if the regulatory architecture fails to keep up. The interface that makes it possible for a rural patient to order his life-saving medicines can also make it possible for a teenager to order antibiotics without a doctor’s prescription. The same platform that makes it easy to compare prices can also allow a substitute product to be ordered in lieu of the one prescribed by a doctor. The solution should not thus be to turn away from digital healthcare but to create safeguards proportionate to the size of the challenge. Epharmacies need to be brought under the ambit of law, not to curb innovation but to ensure that innovation doesn’t come at the expense of the safety of patients. An epharmacy legislation with compulsory registration, secure electronic prescriptions, data protection, defined liabilities and oversight is not a deterrent to growth but a prerequisite for sustainable growth.  E-pharmacies are here to stay. But the question is whether India will legislate to ensure that the benefits are delivered without risks. The role of the legislature and the regulator is not to impede progress but to guide it. The need is to have an online pharmacy ecosystem that delivers both convenience and safety, because a prescription should never turn into a shopping list    The post India’s online pharmacy boom and the perils of unregulated medicine  appeared first on Express Pharma.