Formal recognition and regulation of online pharmacies is a step closer to reality, with health ministry officials set to meet industry stakeholders on 10 June to finalize the rules.
The new government is planning to roll out the e-pharmacy project in its first 100 days, having released the draft rules for it last year.
India’s online pharmacies that currently operate in a regulatory grey area, thanks to conflicting court orders, hope the new rules will bring much-needed clarity to the sector.
According to the proposed e-pharmacy rules which were opened for public comments in September, only government-registered e-portals can sell medicines, and they must retain prescriptions and verify details of patients and doctors.
However, the going has not been easy for online pharmacies. In December, the Delhi high court ordered all online pharmacies in the country to shut by 20 December. In the same month, the Madras high court suspended the ban, after a group of e-pharmacy companies filed an appeal. The order came as a respite for e-pharmacies, but the health ministry now wants to finalize the regulation.
“Regulating e-pharmacy companies is high on the agenda and is part of the government’s 100-day agenda. The Prime Minister who has taken massive steps to push Digital India is keen on this proposal and we hope to give teeth to the online pharmacy business within first 100 days," a health ministry official said on condition of anonymity.
The ministry has received more than 7,000 representations in favour of the draft document. The final rules, when notified, will provide a much-needed boost to e-pharmacies, allowing them to function on par with physical drug stores.
“Any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the central government," the draft said.
Offline chemists opposed the move to allow e-pharmacies to sell medicines, arguing easy availability of drugs can lead to misuse. More than 350 comments from associations as well as individuals were against the draft rules, added another official.
Around 50 startups, including Netmeds, 1mg and PharmEasy, sell medicines online in India.
Pradeep Dadha, founder and chief executive at Netmeds.com said, “We support the government’s initiative towards providing quality healthcare and affordable medicines to the masses. And we believe that the e-pharma regulations will further bring clarity on the legal as well as social responsibilities that entail the industry. As directed by Delhi high court, the centre has released a draft for further consultation and due diligence. We believe that the government will enforce regulations on the conduct of e-pharmacies after careful consideration. As a fully licenced pharmacy, Netmeds.com is committed to adhering to all the guidelines and standards as prescribed under the Drugs and Cosmetic Act, Personal Data Protection Bill as well as the Pharmacy Act. We look forward to operating within a conducive legal framework that would give a much-needed push to the e-pharma and related health-tech businesses."
“The rules are very positive and allow digital platforms to scale while improving compliance in the industry. The government is yet to finalize it, but I would still want more ease of doing business by removing layers of clutches over the business operations," said Dharmil Sheth, founder, PharmEasy.