Online pharmacies, commonly referred to as “E-Pharmacies” remain at an interesting legal position in the Indian context. On the one hand, two different High Courts in India have taken enormously varying stands on the legality of e-pharmacies and the justification of such a business, culminating in near diametrically opposite orders. A few months back, the Madras High Court vacated an interim stay on the sale of pharmaceuticals online, while the Delhi High Court continued extending its stay to the sale of pharmaceutical products online.

On the other hand, in the same public interest litigation filed before the Delhi High Court seeking a ban on online sale(s) of drugs, e-pharmacies have, in response, been making impassioned arguments to contend that they are only technology providers or delivery agents, akin to a Swiggy in the food delivery space and cannot be conflated with outright pharmacies, as traditionally understood.

In the midst of these developments, the Government in June of this year announced that regulations for e-pharmacies would be published in 100 days (which means they should be out any time now).

As we await these regulations, it would be useful to pen down some thoughts on what the contents of these regulations should be.

As a starter, the humble view of this author is that the name “e-pharmacy” itself is a misnomer and nearly anachronistic, when seen in the context of the different kinds of business models that exist in the market for e-pharmacies.

Therefore, the first step would be to define or at least attempt to plot out the different kinds of business models that exist in this space. Certain companies follow the ‘inventory-based’ model, where the sales are driven out of inventory owned or maintained by the relevant company; on the other hand, others follow a ‘market place’ model, where the company connects patients/consumers to nearby pharmacies that would maintain the relevant stocks of the required medicines, based on the requirements of the patient.

If considered duly, the broadest term that could describe these practices as a whole, would be the notion that both facilitate an online purchase of a drug, with the seller being the online company or a registered pharmacy itself, depending on the nature of the model followed.

Any regulations that are drawn on the online sale of drugs should hence clearly call out the different models of sales that exist in the market.

The next step would be to build in the framework of a data trail that is generated for each sale made through such platforms.

In an excellent report published by Frost & Sullivan on the E-Pharmacy market, some of the challenges faced by the retail pharmacy business are the low industry margins, counterfeit medicines, documentation & tracking concerns, as well as poor inventory management. The obvious common denominator in these issues, collectively, is the lack of evolved real time data generation that could potentially overcome these concerns.

An online platform, with a clear record of data and transactions is an obvious panacea to addressing the data gap that brings about these concerns. Each of these matters can be addressed through the data collection process that happens in this space, particularly looking at the transactions of various drugs or products purchased on such platforms. Specific batch numbers, quicker audits, and more sound authentication or verification procedures, as contemplated in the Frost & Sullivan report, could pave the way for bigger improvements in this space. The report goes to say that the e-pharmacy model could prove to be a game changer in a variety of respects, such as preventing drug abuse, addressing medication errors, minimizing dissemination of counterfeit medicines & pharmacovigilance. In this regard, data collection and storage, through a clearly spelled out framework, could go a long way in addressing the above concerns.

Another crucial implement that would be needed in the new regulatory framework is a reformation of the laws surrounding the advertising and promotion of various drugs and pharmaceutical products.

Drug sales and promotion in India continue to be governed by the Drugs & magic Remedies (Objectionable Advertisements) Act 1954 (“DMRA”), which bars the advertising of drugs that are intended to treat or address an identified list of diseases and disorders.

The challenge with this framework is that advertising under the DMRA is given its broadest ambit possible, which means that even simple side by side comparisons of any product on any website (irrespective of the involvement of the manufacturer) would violate the provisions of the said law. These laws, along with the Drugs & Cosmetics Act 1940, have to undergo changes or limitations to ensure that online platforms have the full freedom to display product information and details online, such that the patient transacting on such site is made fully aware of the drug’s specifications, to corroborate the prescription that has been provided by a physician.

Related to the above point would be that the regulations should also classify or attempt to throw some light on the kinds of claims, information and product specifications that can be shared online. Unlike sales driven through a brick & mortar pharmacy (where there are pharmacists there to explain and clarify questions), an online platform would ideally need to offer either an online interface (to allow the patient to raise questions to a pharmacist sitting remotely) or to clarify the exact scope and nature of information that should be provided on the site. This is a crucial component in the process to ensure that the online sale of a drug can carry all of the necessary benefits and capabilities that a sale through a physical pharmacy would offer.

Accordingly, the regulations should prescribe a framework on the scope and contents of product information that should be made available online and a further escalation mechanism in case the patient has further questions to be addressed by a pharmacist.

Lastly, one crucial issue to consider would be the scope of any liability of the online platform, particularly given that this industry looks to participate in a sector that is heavily regulated and is subject to professional standards of duty (i.e., the pharmacy space). With that in mind, how would the role and duties of the online platform be spelled out? Does it only act as a simple dispenser of medications which are ordered and delivered against a validly authenticated prescription? Or what are the further add on services or assistance that could be provided (e.g., query escalation)? How would this aspect get addressed?

Other noteworthy suggestions are also found on various online publications and journals on what these regulations could cover from a data processing, verification, auditing and checking point of view; all of these suggestions, including the recommendations made in the abovementioned Frost & Sullivan report form a detailed wish list of things one would hope to see in these regulations. So, for the time being, this author’s fingers remain crossed.

NOTE: As of the date of preparation of this write up, no norms relating to the regulation of e-pharmacies have been published.