E-Pharmacies May Be Regulated By Dec, 2018

New Delhi, 22 Nov 2018: The centre has started work on the final notification on regulating online pharmacies, after receiving more than 7,000 representations in favour of the draft document.

According to the proposed e-pharmacy rules, opened for public comments in September, only government-registered e-portals can sell medicines, but they are required to preserve prescriptions and verify details of patients and doctors.

“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.

The final rules, which are likely to be notified in December, will provide a much-needed boost to e-pharmacies, allowing them to function at par with brick-and-mortar stores.

Offline chemists opposed the move to allow e-pharmacies, arguing that easy availability of drugs can lead to misuse.

While more than 350 comments, from associations as well as individuals were against the draft rules, the government has decided to make minor changes and go ahead with the regulations.

“We are in the process of compiling the comments received from various stakeholders. The draft needs some minor changes, as suggested by the stakeholders, after which we will come out with the final notification,” said a senior health ministry official, requesting anonymity.

Ministry officials also met industry experts, including retired drug controllers, to fine-tune the rules, besides submitting a status report to the Madras high court, which had barred online sales of medicines by unlicenced dealers.

Around 50 start-ups, including Netmeds, 1mg and PharmEasy, sell medicines online, and the government’s proposal to regulate the market will remove uncertainties surrounding the legality of such sales.

Dharmil Sheth, co-founder, PharmEasy, says it is a move in the right direction—toward a “truly digital pharma ecosystem”. “Online channels will bring in better visibility, transparency, efficiencies and convenience to consumers.”

The draft rules allow online sale of all medicines, except schedule X drugs such as tranquillizers, narcotics and psychotropic drugs.

“The premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorised by the central licensing authority, with or without the experts in the relevant field, or the officers authorised by the concerned state licensing authority.”

“The details of patient shall be kept confidential and shall not be disclosed to any person other than the central government or the state government concerned, as the case may be. The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacyportal and such memos shall be maintained by the e-pharmacyregistration holder as record,” the draft notification said. Livemint