Much like the United States has the Food and Drug Administration, or Europe has the European Medicine Agency, CDSCO is a branch of the Ministry of Health and Family Welfare and aims to monitor the safety, effectiveness and quality of medicines, cosmetics and medical devices and to protect and promote public health. The Drugs Controller General of India (DCGI) is an official body of the CDSCO and is the final regulatory authority for the approval of clinical trials in the country. The procedure for getting an EUA is not clearly definited by India’s drug regulators. Nevertheless, CDSCO has been granting these approvals for drugs like remdesivir, favipiravir and Itolizumab for COVID-19 treatment. Murali Neelakantan, lawyer and former global general counsel for Cipla and Glenmark Pharmaceuticals, told The Indian Express, “We still don’t know the story behind these approvals — we haven’t seen the clinical trial data published anywhere and we haven’t seen the protocols that were followed for each drug.” India’s provisions for EUA for a COVID-19 vaccine are yet to be made clear. According to a government official quoted in the report, it is mandatory for companies to have held local trials for the vaccine among the Indian population. Pfizer has sought permission to import the vaccine for sale and distribution in the country, and a waiver for clinical trials on Indian population. This is in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019. “During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” a spokespersan said. Ram Vishwakarma of the Council of Scientific and Industrial Research - Indian Institute of Integrative Medicine, told The Hindu that the procedure for EUA in India is similar to those in the UK and the US. “So a drug or a vaccine approved by the US FDA is approved here (India) with some bridging studies (limited trials on local population to establish equivalence and effect. Were Pfizer were to apply in India to the regulators here, it could in theory be approved within days or weeks here, depending on whether the Drug Controller is satisfied with the data. If the situation so demands, the regulator has the power to waive or recommend more tests, and doesn’t necessarily require Indian data.”