“Indian vaccine industry needs nurturing to reach its true potential”

Defying all odds and transforming his ideas into reality, Dr Krishna M Ella successfully created synergy between biotechnology and business since the time he founded the Bharat Biotech International in 1996. He is the man behind one of the fastest growing successful indigenous vaccine companies of the country. Dr Ella’s story has been inspirational for many Indian scientists who dream of coming back to their homeland and make a difference. In this candid conversation with Rahul Koul, Dr Ella talks about the journey, challenges, and future. Read the excerpts:  

Congratulations on the grant of WHO’s prequalification to Rotavac vaccine. How do you feel when you think of the long journey that started almost three decades ago?

We are much happy. This is India’s first indigenous vaccine for rotavirus. If we don’t innovate in this country, we won’t succeed. We have come a long way since 1986 when the key virus strain was isolated by Dr M K Bhan in All India Institute of Medical Sciences. Later the initiative was scaled up under Indo-US Vaccine Action Programme involving bilateral governments, national and international partners. It was amazing to witness how 65 scientists from India and US worked on this as it was a massive herculean task.

And then came the efficacy trial which had never happened before. What we do in case of biosimilars is that we give the generic medicine to 100 people and then the original to another 100. Then it is approved. But in case of this vaccine, it had to be given to 10,000 babies in a community-based trial. It was challenging to ask a pregnant mother for consent to give her baby for trial immediately after it is born. We had restrictions by both governments that we should not offer any financial assistance to them. We decided to give best three-year healthcare to mother and children as a benefit. Though it was not an easy task, we have fortunately crossed all the barriers.

Has the situation on clinical trials eased now comparatively?

The situation remains same. There is a lack of awareness and broader understanding. Isn’t it a fact that close to 14 percent baby deaths occur in India and most of these deaths occur naturally. But unfortunately, in India, we have a bad press for vaccines. I agree that there could be some negative effect in terms of vaccine placebo or some other factors but that can’t be ruled out completely.

The clinical trial scenario remains challenging even today. Unless we the Indian companies do the trials in India, where do we test our innovation? If American companies are being opposed on some grounds, what explains opposition to Indian companies that are looking at clinical trials as a part of their innovation programme. We can’t produce vaccines like that.

Is there a way to sensitize the parliamentarians?

We have still to do that. Our judiciary and politicians need to understand that the vaccines are for them too. Of course, the strict regulatory system must be followed. The clinical trials must be monitored and there should be the penalty on those who are unethical. There should be conditions but not in the manner that puts all the companies in the same row. That is the problem in this country. Everybody is treated in the same manner if there is an act of violation by some unethical. The government should realize that there has to be a clear policy.

Will the industry take steps to bridge the mistrust between it and policymakers?

The most of the clinical trials are done by vaccine companies. The data integrity of trials done by pharma companies is hurting us. I think regulatory agencies should be very particular about it. The companies that indulge must be warned that they would be banned for 5 years. That would make them follow the laws and desist them from any unethical act. Regulators have to bring in ethical practices and not treat everybody as bad. Also, I think we need to educate the parliamentarians, political system and judiciary because they have a responsibility of ensuring the best for the people. Otherwise, our innovation would not go anywhere. Prime Minister is talking about ‘Make in India’ but how can we innovate when we can’t do the clinical trials. How can a startup in life sciences survive without clinical trials?

Prime Minister Modi was recently in Davos, inviting world leaders to do business in India. Where can the vaccine industry, that is growing fast, feature in this?

I think the PMO must be briefed properly on this. The vaccine is the only area where we are ahead of the game, in the emerging world. Now we have competition from Korea and China and I think that this is one industry that is ahead of the game. If the government can push us, we can be global players. We need government support. Without it, we can’t win in the longer run.

Does government really need convincing on this? I mean isn’t there an example that has been set?

The government should identify which are the key sectors in this country that have to play the leadership role. They have to do it segmentwise such as the vaccine, pharma etc. Choose the areas not from an Indian point of view but use the global perspective. What push is required for which sector has to be decided on the basis of multiple factors that needs a thorough analysis of ground realities.

Is it correct for the government to slash prices the way it is doing? What do you make of the price control measures for bioscience products?

We should look at China. The Chinese companies are selling the Japanese Encephalitis vaccine at 3 dollars a dose and they made the government increase the price. They are pushing the companies towards being global players.

Comparatively, we have no support from the government. While there are price control measures for the industry, there should be matching support for the indigenous industry. Entrepreneurs should not be chocked from all sides. We are the true and efficient entrepreneurs in all these circumstances.
I think vaccine industry should be treated differently than pharma. We have patents for the technology which makes it more innovative. We are far ahead of others. Let me give an example of Typhoid conjugate vaccine where we are the first country. We beat the multinationals of Europe, the US in every way.

There is also an issue of data. How could we effectively monitor data?

Unfortunately, in this country, there is lack of trust. If the science comes from the US, it is trustworthy but if it is generated by the Indian company, it is not trusted easily. This is because of integrity that needs to be fixed. That cannot only come from the industry. It has to come from the government. The right regulations and the best environment in the academia from school onwards is a must.

The regulatory environment has to be stringent like US-FDA. Then at least we can gain trust. There should be streamlined regulations yet higher penalties for violations by those who try to jump the ethical barriers. Integrity and trust are linked to each other.

What are the next top priorities at Bharat Biotech?

Now we are looking at the development of Chikungunya and Zika vaccines. Besides that we also have HPV vaccine. There is a lot much to do and we are trying to give our best. However, we need nurturing to reach the true potential.

What are your expectations from the union budget?

I think the business has to operate differently from the budget. As an industry, there is less than 1-2 percent effect on our operations. There might be some profit or some loss in terms of budget announcements but we can’t take our decisions only based on that. This is an unnecessary hype on the budget in India. Instead of short-term goals, companies must focus on long-term.

What are the global trends in vaccine development?

Globally, a lot of platform technologies are changing. RNA vaccines are a new trend. We in India have good technologies and we are equally matching up to the global levels.