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Drug regulator flags online sales of medicines, startups say they are safe

Drug-regulator

Indian drug regulator has raised red flag against online retailing of medicines in the country but in the process created more confusion with key e-pharmacies claiming they are well covered and actually welcome the government’s move.

The Drug Controller General of India last week shot off a circular reiterating that sale of drugs over internet contravenes the provisions of Drugs and Cosmetics Rules, 1945, and underlined the urgency to quickly frame laws to regulate the nascent online pharmacy industry in the country.

The government had last year formed a sub-committee under the chairmanship of Harshadeep Kamble, commissioner of Food and Drug Administration, Maharashtra, to assess the feasibility of online pharmacies. But the committee is yet to submit its report.

“All state/UT drugs controllers are requested to put a strict vigil on online sale of medicines and take action against those indulging in online sale of medicines in violation of the Drugs and Cosmetics Act,” the circular said.

The circular has created more confusion than providing any clarity on whether online pharmacies can operate in the first place with some players saying that the notification does not impact them directly.

A spokesperson of online marketplace, which connects the offline pharmacies with consumers, 1mg (formerly known as HealthKartPlus), said, “This is just a reinforcement of what we and a group of organised online pharmacies have been asking for all along—that the pharmacies that do not comply with the Drugs and Cosmetics Act and operate without prescription/registered pharmacists/ sell Schedule X medicines etc whether online or offline should be brought to book.”

The online pharmacy space had come under the regulator’s scanner in May last year after Maharashtra’s FDA filed a police case against Snapdeal for selling prescription drugs.

Snapdeal had said that time it is an online marketplace that allows other merchants to sell to consumers and essentially acts as an intermediary.

Even though it continues to offer health and wellness products on its platform, its website currently does not list prescription medicines.

“The rules are clear at least on the front that licensed pharmacies are the only businesses that are permitted to sell medicine,” Pradeep Dadha, founder of Netmeds, had told VCCircle recently.

Online healthcare startup Medikoe’s founder Sreevalsan Menon said, “The circular does not imply a complete ban on online pharmacies. I don’t see it majorly impacting businesses.”

So what does the current circular entail for the online pharmacies now with the players in the business appearing unaffected by it?

“It’s a pure wait and watch game from here on,” said Bhavik Narsana, partner at law firm Khaitan & Co. “The government has been dealing with this issue now for quite some time, and one would hope for some clarity once the sub-committee tenders its report,” he added.

What does the Drugs and Cosmetics Act say?

The law currently does not permit home delivery of drugs. It has clear guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can be sold only on the prescription of a registered medication practitioner.

Although, most chemists do not insist on a physical prescription to peddle scheduled drugs, some online pharmacies have been tackling the challenge by requiring users to click pictures of the physical prescription on their mobiles and upload it while ordering such medicines.

The government is worried that the unregulated operation of online pharmacies impacts public health, renders drugs recall impossible and encourages drug addiction among youth.

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