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Ministry of Health notifies draft policy regulating online pharmacies

The Union government has released a draft policy regulating the operations of online pharmacies as amendments to the Drugs and Cosmetics Act, 1940. The draft was notified via an extraordinary Gazette of India dated August 28, 2018; the Ministry of Health will receive objections and comments for 45 days hereon after which the draft will be listed on the official gazette and henceforth become the policy for online pharmacies.

Key takeaways

  1. 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 Rs 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.
  2. 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.
  3. 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 localization of data within the country, along the lines of the draft Data Protection Bill, 2018 released in July. Per the draft policy, even mirrored data cannot to be stored outside India.
  4. 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.
  5. Advertising: “No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.”
  6. 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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Draft Policy — Sale of Drugs by E-pharmacies, Amendments to the Drugs and Cosmetics Rules, 1945.

Comments and objections may be sent to drugsdiv-mohfw@gov.in.

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