Ethics preparedness for infectious disease outbreaks research in India: A case for novel coronavirus disease 2019

Over the last several years, the Indian Council of Medical Research (ICMR) has worked with the Department of Health Research (DHR), Ministry of Health and Family Welfare (MoHFW), Government of India, in enhancing the national capacity for early diagnosis of infections that have an epidemic potential by setting up a network of well-equipped Virus Research and Diagnostic Laboratories for managing epidemics that can lead to public health crisis[2]. Permission can be sought from the Drugs Controller General of India (DCGI) for restricted use of combination drugs which are expected to be potentially useful against the infection. [...]on the regulatory front, there have been major strides and a responsive enabling environment has been created for online fast-track clinical trial registration and approvals, registration of ECs on SUGAM Portal and monitoring and accreditation of ECs through National Accreditation Board for Hospitals and Healthcare Providers (NABH)[6],[8]. Clinical Trials Registry of India (CTRI) It is a public database to improve accountability and transparency and ensure that every clinical trial can be prospectively registered. Since 15th June 2009, DCGI has made it mandatory to register all clinical trials on Clinical Trials Registry of India (CTRI) Platform run by the National Institute of Medical Statistics (NIMS) under ICMR[9]. [...]since September 2019, an Office for EC Registration has been created at the DHR, which is now registering ECs and will be coordinating and monitoring the activities of the ECs registered with it.