Enough compliances in place during COVID-19 vaccine development, assures regulator

Drugs Controller General of India has assured that the COVID-19 vaccines being developed and tested in India have followed all the right methodologies as per existing regulatory guidelines

New Delhi: As per Drugs Controller General of India (DCGI), Dr Venugopal G Somani, the regulator ensured best practices during the vaccine development despite the lack of availability of time. “From the correct animal model to seamless Phase 1, 2, and 3 trials, we provided rapid responses wherever required. Whenever anybody approached us with enough scientific data, the approval was provided quickly to compress the development timeline.”
Assuring stakeholders over vaccine safety, Somani added, “Under the restricted use in an emergency situation, we allowed the vaccine candidate to go for further steps if reasonable efficacy was found. Having said that, there was no compromise over safety and all characteristics with respect to testing are in place. If any lacunae were found, the trials had to be repeated. Given the kind of situation, we followed a quick response methodology besides reliance as well as a parallel approach.”
Somani was speaking at a webinar on the ‘Science of Vaccine Development’ by the Department of Biotechnology and Biotechnology Industry Research and Assistance Council on 31st December. The forum witnessed a discussion on speed of development, manufacturing capacities, and other challenges. 
“We hope that the ecosystem that we have created and the cultural change that has come in, along with the proactive planning, we are confident that we will be able to take it forward and deliver to the world,” mentioned Renu Swarup, Secretary, DBT.
Dr Umesh Shaligram of Serum Institute of India said that a EUA on the Oxford-Astrazenca vaccine is expected soon and in early January, 100 million doses stock is ready for vaccination as anticipated.
“We are putting together a cold chain infrastructure along with a robust packaging and distribution system to ensure that every person gets the vaccine,” said Deepak Sapra, Global Head of PSAI, Dr Reddy’s.
Dr Kavita Singh Mission Director, National Biopharma Mission moderated an engaging panel discussion and Dr Shirshendu Mukherjee, Mission Director, Grand Challenges India, delivered the vote of thanks.