India’s new price regulation for medical devices and equipment – impact on price and supply chain due to Drugs (Prices Control) Order, 2013

Summary On February 11, 2020, the Indian Government had gazetted a notification that brought all medical devices and medical equipment sold in India under existing quality and safety regulatory framework by declaring them as “drugs”.  However, this notification has exposed all medical devices to India’s drug price control regulation that was put in place to …

India’s new Telemedicine Practice Guidelines – Analysis and Do’s and Don’ts for Doctors offering teleconsultation

Summary: The Indian Government has published Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines finally clarify India’s position on the legality of teleconsultation. It is now perfectly legal to provide teleconsultation by registered medical practitioners (M.B.B.S and above) in line with the requirements of the Telemedicine Guidelines. It has been clarified that …

All medical devices in India to be regulated as “drugs” – Medical Devices (Amendment) Rules, 2020

Summary: The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. The immediate consequence of …

All medical devices to be regulated: Draft rules notified in India

The Ministry of Health and Family Welfare in India has notified the Draft Medical Devices (… Amendment) Rules, 2019 (Draft Rules) for public comments on October 18, 2019. By notifying these rules, the Indian Government has made its intention clear to regulate all medical devices in a phased manner. As of date, only twenty-three categories …

New Compliances for Health Research on Drugs, Medical Devices and Cosmetics in India

From September 16, 2019, all research conducted in India which focuses on human diseases or conditions in the context of a drug, medical device or cosmetics will have to be reviewed and overseen by a non-governmental body known as Ethics Committee. More specifically, from that date, the Drugs and Cosmetics Act, 1940 (DCA) will begin …

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