LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA

LEGAL AND REGULATORY REGIME OF MEDICAL DEVICES IN INDIA MnA Chambers 1 | 12 APPENDIX A LEGAL PROVISIONS 1. Legal & Regulatory Regime of Indian Medical Device Sector: 1.1 The Drugs and Cosmetics Act, 1940, (“DCA”), together with Rules framed thereunder, viz. Drugs and Cosmetics Rules, 1945 (“D&C Rules”) and the Medical Devices Rules, 2017 (“MDR”) regulates the Indian medical device sector, by governing their authorization, import, manufacture, distribution and sale in India. 1.2 The MDR classifies medical devices into four classes as Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk). 1.3 Each manufacturing location requires a separate license for each Notified Medical Device. The license for manufacturing a Class A or Class B device is issued by the State Licensing…
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Critical Analysis: Judgments delivered in the Cases of Modi-Mundipharma & Indoco Remedies

By Manoj, Advocate The Hon’ble High Court of Delhi recently passed very important judgments concerning the  Drugs Prices Control Order, 2013 (“DPCO 2013”) in the separate cases of Modi-Mundipharma Pvt. Ltd. Vs. Union of India (“Modi-Mundipharma”) and Indoco Remedies vs. UoI (“Indoco Remedies”). These judgments are singularly significant as, apart from the judgment also passed by the Hon’ble Delhi High Court in the case of Reckitt Benkiser, these are the first judgments to deal with the nuances of the provisions of ‘price control’ under DPCO 2013. Read Full Article
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