HYDERABAD : Amid concerns over the Indian drug regulator granting emergency use authorisation (EUA) approval to the indigenous Covid-19 vaccine candidate Covaxin even as its Phase 3 trials are underway, a spokesperson of Bharat Biotech said on Sunday that “as part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO”.
“The product development and clinical trial data thus far have generated five publications, which have been submitted to international peer-reviewed journals, four of which will be published soon,” the spokesperson added.
Bharat Biotech had earlier said that Covaxin has already been evaluated in approximately 1000 subjects in Phase I and II clinical trials with promising safety and immunogenicity results with acceptance in international peer-reviewed scientific journals.
Amid concerns that EUA was given to Covaxin despite its incomplete trial data, industry sources pointed out that there is a provision for accelerated approvals in special situations in the New Drugs and Clinical Trials Rules, 2019, published in The Gazette of India.
The NDCT rules have specified special situations in which relaxation, abbreviations, omission or deferment of data can be considered for new drugs and biological products to be used to expedite the development and approval process in case of life-threatening or serious disease conditions of special relevance to the Indian scenario or unmet medical needs.
“This provision is intended to facilitate and expedite the review of drugs so that an approved product can reach the therapeutic armamentarium expeditiously,” the rules state.