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 regulatory pathway of such applications. Please refer to the circulars issued by the CDSCO, on the following links:

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 Research Council Clinical Trials Unit at University College London (MRC CTU at UCL). The toolkit provides pertinent information to researchers planning a clinical trial in India. It incorporates the best practices in research in India and globally and provides links to useful resources, guidelines and regulations, wherever possible. The development of the toolkit has involved extensive consultation with several Indian experts/stakeholders from academia and industry. It is in accordance with the Indian New Drugs and Clinical Trial Rules, 2019, the Indian Drugs and Cosmetic Act, Good Clinical Practice Guidelines, and the Indian National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.