Able Talk

Dr Renu Swarup

Dr Renu Swarup, is at present Secretary of the Department of Biotechnology, Government of India. She spoke to The Wire about some of the achievements of the Department of Biotechnology (DBT). The Wire is owned and published by the Foundation for Independent Journalism (FIJ), a not-for profit company. Dr Swarup has worked in DBT for 29 years, first as a scientist and now as a secretary of the department since 2018. She is also the chairperson of the Biotechnology Industry Research Assistance Council (BIRAC).

National Biopharma Mission was launched in June 2017. This has given us a major push with the world bank.

Background

What are some of the big achievements of the Department of Biotechnology in the field of health in the last five years?

Whatever we do in the area of healthcare, we obviously keep public health in our mind. A lot of the research that we support is eventually targeted towards that. So when talking about some of the immediate achievements of the DBT in the field of health, let’s start with the Rota Virus vaccine, because that’s obviously our flagship project which we are very proud of, and we’ve made a difference in that. But we have also worked on other vaccines – bringing them closer to their developmental stage.

A major initiative that we’ve brought in is the "The National Biopharma Mission was launched in June 2017. This has given us a major push with the World Bank" and it is implemented by the Biotechnology Industry Research Assistance Council (BIRAC). We support programmes in the biopharma sector through the Biopharma Mission and we also create an ecosystem which helps to keep the pipeline moving. We have also identified the gaps there, which were obviously in the early stage of research, and continue to be supported by the DBT and the BIRAC. There are also gaps in the late stage, taking it through the validation of clinical trials.

If you want to keep the pipeline active, then you have to support young innovators and academic researchers who need access to shared infrastructure. It’s not just about creating facilities but having trained human resources to man those facilities and operate them professionally so
that all the data that comes out is compliant with regulatory standards.

The third vertical of the Biopharma Mission is building capacities. Training is very important here. We have, in fact, now looked at how we would train people for regulatory compliances. We’ve just had a discussion to see how we’ll create a clinical trial network, build capacities on clinical trial sites so that we can really do more clinical trials within the country. And also for these facilities, we need to have a trained human resource who can take this forward.

But we’re also looking at bringing in new disruptive technologies and see how we build capacities there. This involves engaging with global partners.

And the fourth vertical looks at how we build our own tech transfer, intellectual property management and technology management capacities to engage industry in academia.

For public health, the other major initiatives that we’ve done very well in are in the medical devices and diagnostics sector. We’ve actually brought out a large number of low-cost medical devices and diagnostics which, today, are being put together as a package for Ayushman Bharat.

 

These “facilities” you’re talking about – are you developing labs where people can come and use the physical infrastructure? And how are these labs different from, say, the CSIR labs?

These are not labs in the true sense. When you’re looking at a product development chain, the moment a product gets ready for going up for clinical trials or pre-clinical trials, you need to take it through many processes. For example, you need a saline culture, you need to have a characterisation laboratory, you need to have a ‘good manufacturing practices’ facility that prepares the clinical trial batches.

These are not routine research laboratories – these are laboratories which are a part of the manufacturing chain and these are currently available with contract manufacturers or the industry. But then, they may not be affordable to our startups because obviously, the industries have their own profit business models that they have to look into.

So we’ve partnered with industries, and we’ve said, “Okay, we’ll give you a strengthening grant so you become our partner,” and we can then take on a percentage of the cost when they give access to labs.