*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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- In terms of Equity, in the Large States category, Chhattisgarh has the best Delta rate on Equity indicators, this is also reflected in the performance of Chhattisgarh in the Equity Pillar where it ranks 4th. Following Chhattisgarh is Odisha ranking 2nd in Delta-Equity ranking, but ranks 17th in the Equity Pillar of PAI 2021. Telangana ranks 3rd in Delta-Equity ranking even though it is not a top performer in this Pillar in the overall PAI 2021 Index. Jharkhand (16th), Uttar Pradesh (17th) and Assam (18th) rank at the bottom with Uttar Pradesh’s performance in line with the PAI 2021 Index
- Odisha and Nagaland have shown the best year-on-year improvement under 12 Key Development indicators.
- In the 60:40 division States, the top three performers are Kerala, Goa and Tamil Nadu and, the bottom three performers are Uttar Pradesh, Jharkhand and Bihar.
- In the 90:10 division States, the top three performers were Himachal Pradesh, Sikkim and Mizoram; and, the bottom three performers are Manipur, Assam and Meghalaya.
- Among the 60:40 division States, Orissa, Chhattisgarh and Madhya Pradesh are the top three performers and Tamil Nadu, Telangana and Delhi appear as the bottom three performers.
- Among the 90:10 division States, the top three performers are Manipur, Arunachal Pradesh and Nagaland; and, the bottom three performers are Jammu and Kashmir, Uttarakhand and Himachal Pradesh
- Among the 60:40 division States, Goa, West Bengal and Delhi appear as the top three performers and Andhra Pradesh, Telangana and Bihar appear as the bottom three performers.
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- West Bengal, Bihar and Tamil Nadu were the top three States amongst the 60:40 division States; while Haryana, Punjab and Rajasthan appeared as the bottom three performers
- In the case of 90:10 division States, Mizoram, Assam and Tripura were the top three performers and Nagaland, Jammu & Kashmir and Uttarakhand featured as the bottom three
- Among the 60:40 division States, the top three performers are Kerala, Andhra Pradesh and Orissa and the bottom three performers are Madhya Pradesh, Jharkhand and Goa
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In a diverse country like India, where each State is socially, culturally, economically, and politically distinct, measuring Governance becomes increasingly tricky. The Public Affairs Index (PAI 2021) is a scientifically rigorous, data-based framework that measures the quality of governance at the Sub-national level and ranks the States and Union Territories (UTs) of India on a Composite Index (CI).
States are classified into two categories – Large and Small – using population as the criteria.
In PAI 2021, PAC defined three significant pillars that embody Governance – Growth, Equity, and Sustainability. Each of the three Pillars is circumscribed by five governance praxis Themes.
The themes include – Voice and Accountability, Government Effectiveness, Rule of Law, Regulatory Quality and Control of Corruption.
At the bottom of the pyramid, 43 component indicators are mapped to 14 Sustainable Development Goals (SDGs) that are relevant to the States and UTs.
This forms the foundation of the conceptual framework of PAI 2021. The choice of the 43 indicators that go into the calculation of the CI were dictated by the objective of uncovering the complexity and multidimensional character of development governance
The Equity Principle
The Equity Pillar of the PAI 2021 Index analyses the inclusiveness impact at the Sub-national level in the country; inclusiveness in terms of the welfare of a society that depends primarily on establishing that all people feel that they have a say in the governance and are not excluded from the mainstream policy framework.
This requires all individuals and communities, but particularly the most vulnerable, to have an opportunity to improve or maintain their wellbeing. This chapter of PAI 2021 reflects the performance of States and UTs during the pandemic and questions the governance infrastructure in the country, analysing the effectiveness of schemes and the general livelihood of the people in terms of Equity.
Growth and its Discontents
Growth in its multidimensional form encompasses the essence of access to and the availability and optimal utilisation of resources. By resources, PAI 2021 refer to human resources, infrastructure and the budgetary allocations. Capacity building of an economy cannot take place if all the key players of growth do not drive development. The multiplier effects of better health care, improved educational outcomes, increased capital accumulation and lower unemployment levels contribute magnificently in the growth and development of the States.
The Pursuit Of Sustainability
The Sustainability Pillar analyses the access to and usage of resources that has an impact on environment, economy and humankind. The Pillar subsumes two themes and uses seven indicators to measure the effectiveness of government efforts with regards to Sustainability.
The Curious Case Of The Delta
The Delta Analysis presents the results on the State performance on year-on-year improvement. The rankings are measured as the Delta value over the last five to 10 years of data available for 12 Key Development Indicators (KDI). In PAI 2021, 12 indicators across the three Pillars of Equity (five indicators), Growth (five indicators) and Sustainability (two indicators). These KDIs are the outcome indicators crucial to assess Human Development. The Performance in the Delta Analysis is then compared to the Overall PAI 2021 Index.
Key Findings:-
In the Scheme of Things
The Scheme Analysis adds an additional dimension to ranking of the States on their governance. It attempts to complement the Governance Model by trying to understand the developmental activities undertaken by State Governments in the form of schemes. It also tries to understand whether better performance of States in schemes reflect in better governance.
The Centrally Sponsored schemes that were analysed are National Health Mission (NHM), Umbrella Integrated Child Development Services scheme (ICDS), Mahatma Gandh National Rural Employment Guarantee Scheme (MGNREGS), Samagra Shiksha Abhiyan (SmSA) and MidDay Meal Scheme (MDMS).
National Health Mission (NHM)
INTEGRATED CHILD DEVELOPMENT SERVICES (ICDS)
MID- DAY MEAL SCHEME (MDMS)
SAMAGRA SHIKSHA ABHIYAN (SMSA)
MAHATMA GANDHI NATIONAL RURAL EMPLOYMENT GUARANTEE SCHEME (MGNREGS)