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Govt to finalise rules governing online pharmacies on June 10

Online pharmacies in India are a step closer to being formally recognised and regulated, with health ministry officials set to meet industry stakeholders on June 10 to finalise the rules governing them, Mint reported. The government released the draft rules as amendments to the Drugs and Cosmetics Act last August (read a copy here), and plans to roll them out in the first 100 days of its second term. Under the draft rules, only government-registered e-portals can sell medicines, and must retain prescriptions and verify details of patients and doctors.

How big is India’s online pharmacy market?

The online pharmacy market in India is valued at about ₹2,000 crore, according to a report by The Hindu. It said that figures from the Union Health Ministry showed that this was less than 0.5% of the retail pharmacy market.

Court battles over ‘regulatory grey area’

Despite the draft rules, India’s online pharmacy market operates in a regulatory grey area and has been subject to conflicting court orders. In December, the Delhi High Court had banned the online sale of medicines and directed the Delhi government, among others, to implement the order. The order was passed in response to a petition which argued that the medicines were being sold without regulation, and that the sale of medicines online increased the risk of spurious drugs being sold.

The same month, the Madras High Court ordered an interim ban on the sale of medicines by e-pharmacies on a writ petition filed by the Tamil Nadu Chemists’ and Druggists Association (TNCDA), which claimed that e-pharmacies were operating without any regulation. The court demanded that the Union Government and the CDSCO notify rules for the online sale of medicines at the earliest, and no later than January 31, 2019. It reprimanded the Union Health Ministry for prolonging the process, noting that the rules remained at the draft stage, two years after the Union government took up the process. However, after a group of e-pharmacy companies filed an appeal against this order, the Madras HC on January 2 stayed it until further notice, saying that patients would be affected if sales were suddenly banned.

Key takeaways from the draft policy

Here are the main points in the government’s draft policy regulating the operations of online pharmacies:

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Licensing: Online pharmacies have to register with the Central Licensing Authority (CLA) to operate, without which, no person or company can distribute, sell, stock or exhibit drugs through e-pharmacy portals. E-pharmacies have to pay a fee of ₹50,000 to register for a three-year license. CLA is a body set up by the Union Government under the Drugs and Cosmetics Rules, 1945.

E-pharmacy portals: E-pharmacies will receive the orders for retail sales through their respective portals; the portals should furnish expansive details about the portal and controlling entities, details of the directors, partners, owners of the e-pharmacy, official logo, return policy, details of the logistics provider, name of the registered pharmacist, and pharmacy council thereof, contact details of e-pharmacy, and redressal grievance procedure.

Patient data and localisation: Any information generated through the e-pharmacy portal, such as information from prescriptions, will not be disclosed to any other person for any other reason. Details of the patient have to be kept confidential. However, the e-pharmacy is duty bound to disclose such information to the Central or State government if/when required for public health purposes. The draft policy also mandates localisation of data within the country, along the lines of the draft Data Protection Bill, 2018, which was released in July. Per the draft policy, even mirrored data cannot be stored outside India.

Prohibitions: The e-pharmacy portal cannot carry out business or sale of drugs categorised as narcotics and psychotropics under the Narcotic Drugs and Psychotropic Substances Act, 1985, and tranquilizers and the drugs under Schedule X of Drugs and Cosmetics Rules, 1945.

Advertising: “No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.”

Monitoring: The e-pharmacy shall maintain and update its stock information and availability, vendors and suppliers list, registered practitioner. The CLA or the State licensing authority can at anytime direct an e-pharmacy to furnish a prescription on the basis of a which a drug has been dispensed.

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