NEW DELHI: India’s regulatory framework has a specific provision for grant of emergency use authorization (EUA), health ministry said on Tuesday amid concerns that there may not be adequate regulatory clauses in the drug law to support such temporary licensure for
Covid-19 vaccine in the country.
“Not all countries' regulatory framework mentions the phrase emergency use authorisation. That does not mean that specific country does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval,” health secretary Rajesh Bhushan said.
“India's regulatory framework has a specific provision for grant of emergency use authorization although this phrase is not used," he said.
The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local
clinical trial data may be considered for approval, Bhushan added.
“This is our law. Similarly other countries also have their legislations,” he said.
The government said while the national drug regulator is actively considering all the three applications for emergency use and any decision will be based on scientific assessment of the safety, efficacy and immunogenicity of the vaccines, it is hopeful that one or more vaccines will be approved soon.
Urging citizens to keep faith in the country’s institutions, the government said the regulator would undertake a deep and rigorous scrutiny of data.
“Three vaccines are under consideration by the regulator and that is a very satisfying fact. We are looking at the world’s largest immunisation programme. Doubts should not be created on our regulator, our scientific institutions, on the National Technical Advisory Group on Immunisation (NTAGI),” Dr VK Paul, member (health) at NITI Aayog and head of the National Expert Group on Vaccine Administration for COVID-9 said.
Three companies – Pfizer, Serum Institute of India and Bharat Biotech – have applied to the drug regulator seeking emergency use authorization for their respective vaccine candidates. While Pfizer’s vaccine – which has already got an approval for such use in the UK, Bahrain and in a few other countries – has not been tested at all on the Indian population, SII has conducting bridging studies in India for Covishield – developed by
Oxford University and for which
AstraZeneca is conducting extensive human trials in the UK and Brazil. Home-grown Bharat Biotech’s Covaxin is undergoing Phase 3 trials in India.