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Launch of Clinical Trials Toolkit for India

The Clinical Trials Toolkit for India was launched at the Bio-India Summit on 22nd November 2019, by Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India. The toolkit has been developed by Clinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI) in partnership with the Medical […]

New Drugs and Clinical Trial Rules, 2019

On 19th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019 [G.S.R. 227(E)]. These rules will be effective from the date of publication (the only exception being Chapter IV – Ethics Committee for Biomedical and Health Research). Chapter IV of these rules will come into […]

Medical Devices Rules, 2017

On 31st January 2017, the Ministry of Health and Family Welfare (MoHFW) released the Medical Devices Rules, 2017 [G.S.R. 78(E)]. These rules have been effected since the 1st of January 2018. The Medical Devices Rules, 2017 are applicable to: Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, […]