E-pharmacies face many legal bumps on digital road

An uneasy calm prevails over the online pharmacy segment with the next three weeks expected to provide operational direction, albeit from three different institutions.

By January 31, the Centre is expected to come out with its final guidelines to regulate e-pharmacies. This comes against the backdrop of two other developments earlier this month from the Madras High Court and the Delhi High Court respectively, which seemed to send out different signals.

In an ongoing case, the Madras HC vacated an interim stay on the online sale of medicines. Less than a week later, in another similar ongoing case, the Delhi HC continued with its interim order by extending the stay on online medicine sales. The Madras HC case comes up next week and the Delhi HC case comes up in early February.

E-pharmacies find themselves at the heart of several instances of litigation following concerns raised by representatives of the medical fraternity and traditional chemists on the dangers that lurk in being able to order medicines online.

The apprehension is that it paves the way for the abuse of addictive medicines and misuse of prescriptions, among other things. Online chemists counter that they do not sell addictive medicines and the electronic sales, in fact, help keep a better track of medicine and diversions.

However, with the Government inclined to go with all things digital, much will hinge on the e-pharmacy rules that have to be finalised under the Drugs and Cosmetics Act, which, at present, does not recognise online medicine sales.

Efficacy issues

Attempting to clear the confusion on the different HC directives, advocate Nakul Mohta explains, “A stay from one place is a pan-India stay.” And if e-pharmacies continue to sell despite the stay, then it is a violation of the order, he says, adding that they have sent “contempt” notices to the central and Delhi drug regulators for failing to implement the Court order. Along with senior advocate Arvind Nigam, Mohta represents the Delhi petitioner on the issue, dermatologist Dr Zaheer Ahmed.

The Madras HC order allowed the online sale of medicines because customers may be dependent on them, he adds.

Mohta clarifies that their Public Interest Litigation is against the concept of selling medicines online, as sending injections or other critical drugs by courier may affect the efficacy of the medical product and, in turn, harm consumers.

Besides, the online sellers operate in typically urban regions, so it is not like they are addressing an access issue in remote locations, he adds. Their business models create a demand for medicines through discounts, and this creates an unhealthy competition.

“The approach is wrong, you cannot push medicines,” he says, adding that it becomes dangerous as even kids are able to operate mobile phones and order online.

Besides, the transfer of medicine needs to take place at the licensed premise and that does not happen in online selling, he says, adding that medicines are controlled products and there needs to be a clear chain of supply.

‘Only connecting channels’

Pharmeasy co-founder Dharmil Sheth says there is no confusion as Courts are looking to weed out anyone selling medicines unlawfully. Companies like Pharmeasy do not sell medicines, he clarifies.

“We are lead generators and merely connect a customer request to a licensed chemist who provides the medicine,” he says. “We do not stock medicines,” he says, underlining that they are online channels or platforms that connect buyer and seller.

“Organised online players have voluntarily agreed to not honour prescriptions of products that lose efficacy, Schedule X drugs, psychiatric drugs, etc,” he says, welcoming clarity in regulations. The entire segment is pegged at about ₹1,500 crore, a drop in the larger ₹1.2-lakh crore pharmaceutical industry in the country.

Mohta calls for greater discussion before finalising the guidelines. He points to the Government’s own sub-committee report that studied e-pharmacy implications in-depth, a report that had little, if any, public visibility.

As the deadline fast approaches on the finalised guidelines, the Centre has before it a tough balancing act between legitimate concerns of online abuse versus the stated digital roadmap ahead for the country.