Guidance from ICMR for ECs during COVID-19 outbreak
On May 6, 2020 the Indian Council of Medical Research (ICMR) released the National Guidelines for Ethics Committees reviewing Biomedical and Health Research during COVID-19 Pandemic.
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Other research during COVID-19 outbreak
The Central Drugs Standard Control Organization (CDSCO) has issued a circular on the conduct of clinical trials during the COVID-19 outbreak. Please click on the following link to access the circular: CDSCO Circular
COVID-19
In the wake of COVID-19 outbreak globally, government agencies in India and others (globally) have set out guidance for researchers. Following is a list of important links which may help researchers access relevant information and publications: Please note the WHO has requested that the WHO official acronym for the Coronavirus disease (COVID-19) is to be […]
CDSCO regulatory advisory for COVID-19
On 19th March 2020, the Central Drugs Standard Control Organization, announced that in order to encourage the research and development of a drug or vaccine for prevention or treatment of COVID-19, or in-vitro diagnostic kits for the diagnosis of COVID-19, will be processed on high priority. CDSCO shall also provide the required guidance for the […]
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, […]