The Drug Controller General of India (DCGI) has sent anorder to the state drug regulators to take “necessary action” in accordance with the Delhi High Court’s order of December 2018 that had barred online sales of medicines without a license. Presently, no license is issued for online pharmacies as there are no comprehensive rules to regulate the sector.

E-pharmacies follow the marketplace model where they operate through a licensed medicine retailer partner to service a prescription or order that they generate through their online platform. Sources in the government said that if the present model was allowed to be continued, then there was no need to have rules to regulate the space.

A senior government official said that the draft rules to regulate online pharmacies were released last year, but are not yet notified. Unless they are notified, the e-pharmacy model cannot be allowed to operate. A group of ministers (GoM) had met to discuss regulations for e-pharmacies.

Senior executives of leading e-pharmacies in the country said that they would wait until the Central Drugs Standard Control Organization (CDSCO) issued a formal notification saying that the present model of servicing customers through generating prescriptions online would not be allowed. Also, when such a notification comes, they will challenge it legally. Founder of a leading e-pharmacy reasoned that 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.

Another senior executive from an e-pharmacy said that if the government decides to implement such a thing, they would definitely challenge it in court of law. Besides, if they 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.

Last December the Delhi High Court had said online sale of medicines without a license was injuncted, and had instructed the government to confirm that the same was prohibited directly. The Madras High Court had suspended the ban in the same month after e-pharmacy companies filed an appeal against the courts earlier order.

E-pharmacy companies say there is a need to have a comprehensive set of guidelines for the sector. Currently, the business is perfectly legal as it is covered under the IT Act and also the Drugs and Cosmetics Act. However, there is a need for regulation in the sector to boost both investor and consumer confidence.

As per the draft rules for e-pharmacies, only government-registered e-portals can sell medicines and they have to 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 favor of the draft document and about 350 comments against the rules.

Digital Health Platforms, an association of entrepreneurs operating in the digital health industry, held a press meet in the Capital on Tuesday and it raised concerns surrounding the delay in notifying the rules.

Source: Business Standard