The Drug Controller General of India
(DCGI) has sent a directive to the state drug regulators to take “necessary action” in accordance with the Delhi High Court’s order of December 2018 that barred online sales of medicines without a licence.
At present, no licence is issued for online pharmacies
as such as there are no comprehensive rules to regulate the sector.
E-pharmacies follow the marketplace model whereby they operate through a licensed medicine retailer partner to service a prescription or order that they have generated through their online platform. Sources in the government said if the current model was allowed to continue, then what was the need to have rules to regulate the space.
“The draft rules to regulate online pharmacies
were released last year, but are yet to be notified. Until they are notified, the e-pharmacy model cannot be allowed to operate,” said a senior government official. A group of ministers (GoM) had recently met to discuss regulations for e-pharmacies.
The industry feels otherwise. Senior executives of leading e-pharmacies in the country said they would wait until the Central Drugs Standard Control Organization (CDSCO) issued a formal notification saying that the current model of servicing customers through generating prescriptions online would not be allowed. "Secondly, when such a notification comes, we will challenge it legally," said the founder of a leading e-pharmacy. He reasoned that the while the Drugs and Cosmetics Act of 1940 did not mention anything about generating prescriptions through the electronic mode, the e-pharmacy model was well covered under the regulatory purview by the IT Act 2000 under the concept of intermediaries.
"If the government decides to implement such a thing, we would definitely challenge it in court of law. Moreover, if you follow this, then generating orders over phone calls or even through social media platforms like Whatsapp is not covered under the Drugs and Cosmetics Act, which is common practice for brick-and-mortar stores," said another senior executive from an e-pharmacy.
Last December the Delhi High Court had said online sale of medicines without a licence was injuncted, and had instructed the government to ensure that the same was prohibited forthwith. On the other hand, the Madras High Court had suspended the ban in the same month after e-pharmacy companies
filed an appeal against the court's earlier order.
feel strongly about the pending e-pharmacy rules as they say there is a need to have a comprehensive set of guidelines for the sector. "At present, the business is perfectly legal as it is covered under the IT Act and also the Drugs and Cosmetics Act. There is, however, a need for regulation in the sector to boost both investor and consumer confidence," said the CEO of an online pharmacy.
According to the draft rules for e-pharmacies, only government-registered e-portals can sell medicines. They have to also retain the prescriptions and verify the details of patients and doctors. The draft was opened for public comments and the health ministry received more than 7,000 representations in favour of the draft document and around 350 comments against the rules.
On Tuesday, Digital Health Platforms, an association of entrepreneurs operating in the digital health industry, held a press meet in the Capital where it raised concerns around the delay in notifying the rules.