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…
