India-UK Healthcare Collaborations Need Uniform Regulations and An Influx of Capital
LONDON CALLING: The healthcare sector offers the next big opportunity for extensive collaborations between India and the UK. Astra Zeneca – Covishield vaccine is an excellent example of how a shared passion for discovery led to one of the biggest successes in the pandemic world. But experts believe both countries need to do more to synergise their strengths and remove roadblocks, writes Ruhi Khan.
The collaboration between the University of Oxford and the Serum Institute of India (SII) in producing the Astra Zeneca – Covishield vaccine to fight Covid-19, has set a new benchmark for UK-India partnership in healthcare. The first vaccine to get approval during the pandemic is an excellent example of merging the research excellence of a British university with the manufacturing capabilities of an Indian company to create one of the biggest success stories in healthcare.
Nearly 3 billion doses of Oxford- Astra Zeneca vaccine have been distributed and a vast majority of that supply was done by the SII. India’s Wockhardt with manufacturing capabilities in the UK has also been vital to help boost production.
Professor Catherine Green, Head of Nuffield Department of Medicine’s Clinical Biomanufacturing Facility at the University of Oxford, believes that the “passion for discovery” helped the two countries not just sustain this collaboration, but see it grow. Green led the team that made the first breakthrough on vaccine research and collaborated with SII for its production.
“SII was extraordinary and proactive in getting a very rapid, very efficient tech transfer process that they needed to make the vaccine in an extremely high quality in record time,” says Green at the 4th India-UK healthcare conference in London.
The day-long conference at the Royal College of Physicians, saw several leading health experts from India and the UK discuss the ways in which the two countries could maximise their potential. The health sector is a priority sector of both the governments and features prominently in the ongoing discussions of the India-UK Free Trade Agreement.
The recent visit of British Prime Minister Boris Johnson to India affirmed his commitment to invest in bilateral collaborations on health care. In the 2030 Roadmap, the two leaders agreed to enhance global health security and pandemic resilience, promote healthy societies and strengthen both health systems through increased collaboration on clinical education, health worker mobility and digital health. The two countries also promised to show leadership on Anti-Microbial Resistance.
India and the UK have “complementary capabilities”, says Indian High Commissioner to the UK, Gaitri Issar Kumar. While the UK can boast of biotech innovation, healthcare services and infrastructure provision, health care research and education, India has high capabilities in drug and vaccine production, contract manufacturing, medical training and technology start-ups, thus making their strengths “synergistic”.
One red flag raised during the covid vaccine rollout was regulation. “There is a lot of scope for making efficiency savings in regulatory services”, says Green, who believes that connecting the regulatory environment of the two countries will help decide how we go through clinical trials and the eventual licensing of the medicines. There needs to be “more alignment of regulatory space” that worked well during the pandemic and has set a way forward.
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Ltd, believes that there is a “compelling and natural affinity” for both UK and India to collaborate on R&D and a post-pandemic and post-Brexit world provides a unique opportunity to bring about “regulatory harmonisation between Medicines and Healthcare products Regulatory Agency and Central Drugs Standard Control Organisation when it comes to frontier medicine and frontier technologies” like cell and gene therapies and medical devices.
Echoing her, Professor Prashant Jha, Head of Affordable Medical Technologies, King’s College London asks, “Can we please just adopt a homogenous system and stop introducing laws one after another and stop confusing us?” Citing an example of one of his medical technology products classed under two different categories in two different Indian states, Jha insists that clarity in regulations relating to medical devices is important.
This is where Jha believes the UK can leverage its strength and benefit India in drafting trial frameworks for new technologies, while “India can help put ‘big’ in big data” as a trial that will run in the UK for a few years can be run in India in a few months because of the sheer size and diversity of its participants. And as India is “not a data island”, the flow of knowledge between the two countries would be robust.
Jha explains that you can use the model of ‘AI on a train’ where you don’t bring data from India to the UK, you send a question to India, it gets processed there and you get your result, so there is no literal transfer of data bank, and a regulatory framework will bring clarity to the process.
Professor Shahid Jameel, Research Fellow at Oxford University insists that a strong regulatory environment in India would need a very strong political will. “Pandemics are managed with trust and transparency,” he says, critiquing the lack of open hearings on vaccine approval in India, unlike the US and UK. Jameel is also concerned that India has systematically weakened its university research capabilities at the cost of small specialised institutes. He recommends placing these institutes within a university campus for a better exchange of knowledge and skills.
Another major concern is the lack of a steady influx of capital in research and development in the health care sector. The pharmaceutical industry in India is currently valued at $41.7 billion with India as a major exporter of Pharmaceuticals to over 200 countries, including supplying 50% of the generic medicines to African countries. The last decade saw Indian pharma exports grow by 103%. Around £180 billion is spent on R&D in pharma annually but the probability of success is 4%, with a long gestation period of 10-14 years to get a new entity in patients.
“It’s a high stake game, both in money and time,” says Dr Ravi Limaye, Managing Director, Wockhardt, UK. He believes that the industry is realising that it is important to encourage diversification for the acceleration of innovation. “Start-ups bring diversification, they bring speed,” says Limaye citing the example of the covid vaccines which all had an element of a start-up in them. While the UK can bring cutting edge research on the table, India with its large patient pool, qualified research scientists and world-class academia can play an important role to bring in cost arbitrage in the clinical stage of pharmaceuticals which encompasses almost 60% of the total costs, says Limaya.
The Indian medical technology sector, though nascent, is worth around $10 billion and growing exponentially and expected to reach $50billion by 2025. It also requires less investment than pharma and has a shorter gestation period of 3-5 years, which offers opportunities for angel investors in both countries to tap into this growing market. However, the Indian government is the biggest venture capitalist in India for med tech, even though India allows 100% foreign direct investment in the sector.
According to Jha, it is easy to be “buried in early investment” but there is an “absolute dearth of investment for the transition from proof of concept to the market”. This involves running a complex trial and taking the product through an unknown regulatory terrain, which is extremely costly but this is an area where the money is missing.
A two-year turnaround for the covid vaccine is considered nothing short of remarkable. According to Green, the vaccine task force in the UK had a “more venture capitalist mindset” of how to fund the vaccine programme – backing up a lot of good horses, identifying early those that will not go and then supporting the strong ones but keeping in mind that the rate of failure would be high.
The Serum Institute of India has already announced an investment of £240 million in the UK to support clinical trials, research and development and manufacturing of vaccines. SII has already begun phase one of the trials for a one-dose nasal vaccine for coronavirus in the UK.
Minister for Health and Family Welfare, Mansukh Mandaviya, addressed the conference through a video link. He called India and the UK as “natural partners”, who have a history and potential for collaboration in the healthcare sector and acknowledged that this became stronger during the pandemic situation. He hopes to expand such collaborations in pharmaceuticals, digital health, genomics, use of artificial intelligence. Calling India the “pharmacy of the world”, the minister also promoted Ayurveda and India as a destination for medical tourism – Heal in India and Heal by India.
Ruhi Khan is a journalist based in London and the author of Escaped: True stories of Indian fugitives in London. She tweets @khanruhi.