*Disclaimer-The interview is published as is and without any editorial oversight by us.
Interview with Dr. K Vijay Raghavan, secretary, Department of Biotechnology.
India is all set to lead the global fight against epidemics as it is a key member of the newly formed Coalition for Epidemic Preparedness Innovations (CEPI) with its headquarters at the Norwegian Institute for Public Health, in Oslo. The coalition will not focus on diseases that already have sufficient attention, but will be guided by WHO’s R&D blueprint (2016), which lists eleven illnesses to focus on, including Chikungunya, Middle East Respiratory Syndrome (MERS), Crimean-Congo Haemorrhagic fever. Dr K Vijay Raghavan, secretary, Department of Biotechnology, India, has been chosen as the chairperson of the interim board. In this interview, he talks about the coalition and its goals.
What will be India’s role as a leader of this coalition?
When disease outbreaks occur, depending on the mode of transmission they can spread very rapidly to affect people very far from where the outbreak starts. In India, we recognise that preparedness to handle outbreaks also includes strategies for prevention.
For known and as yet unknown diseases, vaccines offer the potential to be deployed rapidly and on scale to prevent both disease and its further transmission. India, represented by the Ministries of Science and Technologies and Health and Family Welfare, intends to stand shoulder-to-shoulder with governments and agencies, such as the World Health Organization, the Wellcome Trust and others to develop the strategies for partnerships, technical development, regulatory and ethical approaches and find the resources and commitments needed for the coalition.
Indians have developed effective vaccines that are yet to be utilised – will these feature prominently?
The term ‘effective’ in science and in common use reflect different levels of rigour. There are actually relatively few ‘effectiveness’ or efficacy studies of vaccines developed in India. The last vaccine developed in India which underwent an efficacy study was the rotavirus vaccine made by Bharat Biotech with the support of the Department of Biotechnology, and this is now being used by the MOHFW in four States, with plans to expand nationally in the near future.
The coalition will not focus on common diseases like rotavirus, but will focus on diseases that have the potential for causing outbreaks. Among the known diseases that may be targeted is Chikungunya, for which a vaccine has been developed in India, but its effectiveness in preventing the disease needs to be evaluated. It is possible that support for such studies for existing, partially tested vaccine may be available.
In addition, we will be looking at new targets, as well as establishing platform technologies that will allow us to rapidly address the currently unknown diseases which may cause outbreaks in the future.
How are the human trials planned to be carried out?
For testing any new vaccine, safety is paramount and the vaccine is first tested in a small number of healthy people in phase 1 studies. Only then does the study move to a slightly larger number of people in phase 2 to figure out what dose is best to produce the best immune response. After that, come the larger scale phase 3 efficacy studies to test whether the vaccine can prevent disease in its target populations. While the phase 1 and 2 studies can be done anywhere, phase 3 studies require a population where the disease is reasonably likely to occur, so phase 3 would have to be where the outbreak is happening.
Under this coalition, the plan is to develop vaccines through phase 1 and 2, and we will apply the highest standards for safety in these studies. In more industrialised countries, many vaccines are now being tested in a unique form of volunteer studies, where disease is actually induced in people in a tightly controlled setting — the controlled human infection model or CHIM and the ability of the vaccine to prevent disease is characterised, so that fewer people are put at risk when testing vaccines. This requires volunteers who are altruistic and have great understanding of the risks of the experiments. There are currently no plans to do such studies in India, but may be, in a few years, we will feel ready to think about such approaches.
Which are the diseases being actively targeted? What is the strategy?
The targets will largely reflect the WHO R & D blueprint which has been evolved over the past couple of years. The goal of the coalition is to focus on diseases which do not have a large market in global terms; therefore, targets have been identified through a careful process of considering candidates that have been through some pre-clinical testing, but might not proceed to further testing because vaccine manufacturers do not consider the returns to be sufficient for the investment they need to make.
As you can see from the CEPI website, much progress has been made on Zika , and for dengue, there is already one licensed vaccine available and at least three other candidates are in late phases of development, so it is unlikely to be considered. Swine flu and other influenza viruses cause diseases with the potential to result in pandemics, and for such diseases, there will be big markets and the bigger vaccine manufacturers will be developing vaccines in any case.
There is a perception that India will be the pharmaceutical hub of the world and also the laboratory for the world… How does this new role ensure our global leadership, especially in having a say on ethical practices in these sectors?
Ethical practices relate to both the development of drugs, vaccines and other products which is the domain of academia and regulatory authorities as much as manufacturers and to their marketing and use, where manufacturers have the greatest role.
In development and testing, we will adhere to the highest ethical standards, ensuring that participants in studies completely understand the purpose as well as the risks and benefits of their participation. This will require strong credible academic partners and regulations, and the Drugs Controller General of India has already taken the lead in improving the standards of clinical testing in India.
How much money is needed to be raised, and will India have a part in raising funds as well?
The anticipated requirements for funding is about 200 million US dollars per year, which is relatively modest. Yes, India will have a role in contributing, but the scale of contribution is not yet defined.
CEPI has announced a plan of getting more people on board – What is likely to be India’s role in this ?
India is home to one sixth of the world’s people. Our people live and travel everywhere. This is important for us, but we must also bring other partners on board. India will play a role in working not only with industrialised countries, but also with less resourced settings, particularly in Asia and Africa. The India-Africa Health Summit, organised by the ICMR and supported by four Indian ministries is an example of the kind of engagement where we could work with African countries likely to be affected by outbreaks that need to build capacity in science, medicine and manufacturing.
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Steve Ovett, the famous British middle-distance athlete, won the 800-metres gold medal at the Moscow Olympics of 1980. Just a few days later, he was about to win a 5,000-metres race at London’s Crystal Palace. Known for his burst of acceleration on the home stretch, he had supreme confidence in his ability to out-sprint rivals. With the final 100 metres remaining,
[wptelegram-join-channel link=”https://t.me/s/upsctree” text=”Join @upsctree on Telegram”]Ovett waved to the crowd and raised a hand in triumph. But he had celebrated a bit too early. At the finishing line, Ireland’s John Treacy edged past Ovett. For those few moments, Ovett had lost his sense of reality and ignored the possibility of a negative event.
This analogy works well for the India story and our policy failures , including during the ongoing covid pandemic. While we have never been as well prepared or had significant successes in terms of growth stability as Ovett did in his illustrious running career, we tend to celebrate too early. Indeed, we have done so many times before.
It is as if we’re convinced that India is destined for greater heights, come what may, and so we never run through the finish line. Do we and our policymakers suffer from a collective optimism bias, which, as the Nobel Prize winner Daniel Kahneman once wrote, “may well be the most significant of the cognitive biases”? The optimism bias arises from mistaken beliefs which form expectations that are better than the reality. It makes us underestimate chances of a negative outcome and ignore warnings repeatedly.
The Indian economy had a dream run for five years from 2003-04 to 2007-08, with an average annual growth rate of around 9%. Many believed that India was on its way to clocking consistent double-digit growth and comparisons with China were rife. It was conveniently overlooked that this output expansion had come mainly came from a few sectors: automobiles, telecom and business services.
Indians were made to believe that we could sprint without high-quality education, healthcare, infrastructure or banking sectors, which form the backbone of any stable economy. The plan was to build them as we went along, but then in the euphoria of short-term success, it got lost.
India’s exports of goods grew from $20 billion in 1990-91 to over $310 billion in 2019-20. Looking at these absolute figures it would seem as if India has arrived on the world stage. However, India’s share of global trade has moved up only marginally. Even now, the country accounts for less than 2% of the world’s goods exports.
More importantly, hidden behind this performance was the role played by one sector that should have never made it to India’s list of exports—refined petroleum. The share of refined petroleum exports in India’s goods exports increased from 1.4% in 1996-97 to over 18% in 2011-12.
An import-intensive sector with low labour intensity, exports of refined petroleum zoomed because of the then policy regime of a retail price ceiling on petroleum products in the domestic market. While we have done well in the export of services, our share is still less than 4% of world exports.
India seemed to emerge from the 2008 global financial crisis relatively unscathed. But, a temporary demand push had played a role in the revival—the incomes of many households, both rural and urban, had shot up. Fiscal stimulus to the rural economy and implementation of the Sixth Pay Commission scales had led to the salaries of around 20% of organized-sector employees jumping up. We celebrated, but once again, neither did we resolve the crisis brewing elsewhere in India’s banking sector, nor did we improve our capacity for healthcare or quality education.
Employment saw little economy-wide growth in our boom years. Manufacturing jobs, if anything, shrank. But we continued to celebrate. Youth flocked to low-productivity service-sector jobs, such as those in hotels and restaurants, security and other services. The dependence on such jobs on one hand and high-skilled services on the other was bound to make Indian society more unequal.
And then, there is agriculture, an elephant in the room. If and when farm-sector reforms get implemented, celebrations would once again be premature. The vast majority of India’s farmers have small plots of land, and though these farms are at least as productive as larger ones, net absolute incomes from small plots can only be meagre.
A further rise in farm productivity and consequent increase in supply, if not matched by a demand rise, especially with access to export markets, would result in downward pressure on market prices for farm produce and a further decline in the net incomes of small farmers.
We should learn from what John Treacy did right. He didn’t give up, and pushed for the finish line like it was his only chance at winning. Treacy had years of long-distance practice. The same goes for our economy. A long grind is required to build up its base before we can win and celebrate. And Ovett did not blame anyone for his loss. We play the blame game. Everyone else, right from China and the US to ‘greedy corporates’, seems to be responsible for our failures.
We have lowered absolute poverty levels and had technology-based successes like Aadhaar and digital access to public services. But there are no short cuts to good quality and adequate healthcare and education services. We must remain optimistic but stay firmly away from the optimism bias.
In the end, it is not about how we start, but how we finish. The disastrous second wave of covid and our inability to manage it is a ghastly reminder of this fact.