Covid-19 response: Krishna Ella sees ‘delay’ in regulatory process

Hyderabad, February 24

The regulatory process for Covid-19 vaccine research in the country was a ‘bit late’ according to Krishna Ella, Chairman and Managing Director, Bharat Biotech International Ltd, which made the first indigenous Covid-19 vaccine, Covaxin.

In a panel discussion on two years of pandemic at the BioAsia 2022 on Thursday, Ella said a faster regulatory approval process could have been helpful in dealing with the Delta variant.

Referring to efficacy trials of the vaccines and their approval process, Ella said: “the regulatory mechanism was a bit delayed in the beginning in India. ‘‘

If that was a `little activated’, the timelines for vaccine development could have been much faster and Bharat Biotech could shift straight to the human trial., Ella said.

If Bharat Biotech had “that luxury in India’’, it would have got it in the efficacy trial when the delta (variant) was there, Ella said.

Stating that the a regulator should understand when to do the efficacy trial and the relation between a clinical trial and the disease burden, he said: ``But that knowledge is not there in this country.’‘

Rajesh S. Gokhale, Secretary, Department of Biotechnology, was quick to respond to Ella by saying: “Our regulatory committees are not like venture capital mindset right now.’’ The incomplete scientific data or fluid scientific analysis could not be accepted as duty and law, bind one, which is where things can be slow, the official added.

“Biosecurity is as relevant and important as other security aspects. The government is excited about co-development and co-creative activities with companies and industries,’’ he said.

Equitable healthcare

Soumya Swaminathan, Chief Scientist, WHO, said even though WHO put out a framework for equitable healthcare access and share them equitably, countries did not play by that and each country, was trying to look after itself.

“This has resulted in over 70 per cent of people in high income countries vaccinate against less than 10 per cent of people in African countries. The worst affected were poor, the marginalised or those who had poor safety net. The science was amazing but the solidarity was lacking,’’ she said.

Countries were now discussing a treaty for a pandemic agreement for binding principles or agreements on how countries must act, the WHO official added. 

Research in biopharma

Amitabh Kant, CEO, NITI Aayog, said the government should incentivise research in biopharma to help India transition from a low-volume, high value player to a high volume, high value player.

“We are also examining the ways to strengthen the R&D system and push for greater industry-academic collaborations. There is a need to promote innovation, global partnerships, and knowledge sharing among our scientific community. 

On the impact of ‘surplus’ Covid-19 vaccine production, Mahima Datla, Managing Director, Biological E Ltd, said: “To be able to cover at least 60 per cent of the world’s population, we might feel comfortable about the vaccine situation as it helps in the context of equity.’’

The panel discussion was moderated by Gagandeep Kang, Virologist and Professor, Dept. of Gastrointestinal Sciences, CMC Vellore

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