Introduction
In early 2020, when countries across the world were scrambling to access crucial RT PCR diagnostic kits for COVID-19, India launched a collaborative effort between academia, government, and philanthropic organisations. One year later, and thanks to CCAMP InDx (Indigenisation of Diagnostics), a digital marketplace that supports rapid indigenous production of RT PCR diagnostic test kits, India is enabling 150 medium and small enterprises to manufacture over one million test kits per day, making high quality RT PCR test kits available in-country at an affordable price. Today in India, it costs less than INR 700 (US$ 10) to get an RT PCR test, when just one year ago, the price was over INR 4400 ($70).
This story reflects how India’s effort in bringing multiple partners together, including the Prime Minister’s Principal Scientific Advisor’s Office, academic organisations from the biotechnology cluster, and private manufacturers, to not only scale up in a quick span of time and achieve self-reliance in manufacturing RT PCR diagnostic kits, but also prepare to export them abroad. Particularly because InDx’s is also to offer technical and market support to emerging diagnostic companies in their manufacturing scaleup, in line with international good manufacturing practice (GMP) standards.
Key takeaways
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In May 2020, when India was beginning to see a sharp rise in Covid case numbers, the shortage of testing kits was making it difficult for policy makers to gauge the true extent of the pandemic. The erratic supply of imported kits led to delays in testing, and the high cost of kits heightened the barrier to access. In the initial days of the pandemic, India could barely manage to get few hundred tests1 and testing had to be urgently scaled up to understand disease trajectory. India had no option but to indigenously manufacture these kits. This is when the office of Prime Minister of India’s Principal Scientific Advisor (PSA) called upon the institutes that are under its biotechnology cluster to research how to train India’s medium and small enterprises in developing reagents required to manufacture the final test kits. (The PSA’s office was created in 1999 to provide “pragmatic and objective advice to the Prime Minister and the Indian cabinet on matters related to science, technology and innovation…” with a specific focus on application of science and technology in key social and economic sectors.2)
While members of this government office were evaluating the value chain, they realized the sheer size of this endeavor demanded a structured platform where manufacturers, academic institutions, and end buyers could come together.
“We wanted to build a marketplace that could support these wide range of organisations and that is when we reached out to TCS to build a marketplace”, said Sapna Poti, Programme Director, Office of PSA.
Then, TCS or Tata Consultancy Services, India’s leading IT service provider, decided to build the digital platform pro bono.3 But building a platform alone was not enough. Putting together a team that could drive such an initiative needed financial backing, too. This came with the help of The Rockefeller Foundation.
“Our foundation in its Covid response was looking at increasing equitable access to testing. In partnership with the Government of India and with guidance from the Principal Scientific Advisor (PSA) office, we assessed market opportunities for ramping up domestic supply chains to increase production of COVID-19 molecular tests”, said Manisha Bhinge, Managing Director Health Initiative, The Rockefeller Foundation. “We started with a set of hypotheses, and one of them was that there was latent capacity within the Indian biotechnology sector to scale volumes of key reagents and primers while maintaining a consistent commercial grade quality, comparable to the export market. Our hypothesis was proven accurate, the capacity existed and it needed strategic interventions in the form on technical assistance, process R&D and capacity development”, Bhinge explained.
This assumption was proven right, as The Rockefeller Foundation was put in touch with the Bengaluru Biotechnology Cluster the PSA’s office had nurtured over the years in the southern Indian city of Bengaluru, where C-CAMP4, The National Center for Biological Sciences (NCBS) and The Institute for Stem Cell Science and Regenerative Medicine (InStem) are located. These institutions, with the backing from the office of PSA, and funding from The Rockefeller Foundation, became the core academic organisations that drove the InDx platform.
The program was kicked off to establish a strong supply chain network of Indian MSMEs, working alongside them to ensure that international quality standards were met. The aim of the platform was to support diagnostic companies in their scale-up effort in all components of RT PCR tests. From manufacturing of diagnostic kits, reagents, to finding customers, the InDx digital marketplace designed by TCS became a one-stop platform for companies to achieve production of a million tests per day. By connecting diagnostic companies with relevant centers of excellence units across several institutions, the platform linked scientific and commercial expertise in manufacturing the diagnostic tests.
In August 2020, three months into the May 2020 idea, the platform was conceptualised and implemented.
Teething troubles
But despite the speed at which this platform came to life, the team did face initial teething troubles. One of them was the shortage of staff and funds. The Bangalore Biotechnology cluster that was supported by the PSA had the expertise on developing molecular tests, but the leadership and structure needed to scale up the platform was missing. The second challenge was finding a financial partner that could fund a platform of this nature, one that was not for profit yet needed immediate investment for initial structure.
As conversations progressed, The Rockefeller Foundation stepped in to fund the platform5 with an investment of USD $3.5 million by early August, though conversations with the PSA on how to shape the initiative had started in May 2020.
“The biggest challenge in launching such initiative is that investors/donors want to see the end result, but nobody wants to fund the process”, said Poti. “The risk appetite is low among investors when it comes to innovation and research”, she added. “So convincing potential investors to fund an upcoming platform such as InDx was a tough hurdle, as most of them are looking for readymade products”, Poti said.
“The urgency of the pandemic opened up the risk appetite for such a project. We are also glad that our hypothesis regarding domestic scale-up was proven right”, said Bhinge of The Rockefeller Foundation.
Once the funding was in place, the platform needed a team of people who could manage the operational aspect of the initiative. Though it was a pan-India platform, Bengaluru and Hyderabad became the two main coordinating cities of the project. The C-CAMP in Bengaluru was the ‘Programme Management’ (PM) unit responsible for overseeing the entire platform. Consisting of five people, it is led by a Chief Operations officer, Chief Scientific Officer, and Chief Technology Officer. This core team coordinated with the center of excellence, manufacturers, donors, and the government of India.
Dr Taslimarif Saiyed, Director and CEO (C-CAMP), Dr Satyajit Mayor, Director NCBS and Prof. Shashidhara, Dean Research, Ashoka University are the core team for the C-CAMP InDx platform. Dr Sapna Poti, Director Strategic Alliance and Partnerships, and the office of PSA provided the government backing to this initiative, and Dr Manisha Bhinge, Managing Director Programe and Partnerships (Health Initiative) at The Rockefeller Foundation oversaw the project as its funder.
Once the team and operations were sorted, the next hurdle was finding MSMEs that were up to the task of rapid scale-up of high quality kits.
“MSMEs in the diagnostic space in India had the capability to manufacture high-end diagnostic test kits but weren’t ready with technical expertise to develop test kits from the scratch at breakneck speed. Since Indian companies in the past were largely focused on manufacturing of diagnostic kits and not much their development, they needed scientific backing to develop high-quality RT PCR tests”, said Dr Saiyed, Principal Investigator, InDx and CEO of Bengaluru based institution Center for Cellular and Molecular Platforms (C-CAMP).
Dr Saiyed explained that development of a RT PCR test involves expertise in manufacturing of several components such as reagents, enzymes, etc. All these elements had to be produced at the highest quality level that could stand the muster of domestic and international regulatory agencies.
To ensure high-quality production the InDx team identified 60 to 70 companies who had the potential but did not have expertise, infrastructure, or resources required to manufacture these kits. They would need handholding to leap into high-quality manufacturing.
Getting the promising practice out
The InDx platform decided to plug this gap by creating an ecosystem where companies could get real time feedback on the development of the test kits, and also connect them to potential buyers. Eight ‘Centres for Excellence’ (COEs) across areas of clinical development, Chemistry, Biologics, Quality, Informatics, Antigen/Antibody, Microfabrication, as well as pilot scale, scale up, and business analytics6 were established to guide companies through the validation and commercialisation stage of manufacturing. The COEs’ role was to improve the quality of domestically made kits, support companies with clinical development, share scale-up technologies for production of components such as enzymes, evaluate interchangeability options, and finally, help companies in finding buyers for the kits. While the CoEs assisted companies in these areas, the InDx digital platform became a marketplace that addressed supply chain gaps to procure the components needed to manufacture test kits.
Once the CoEs were established, manufacturers only had to send all their materials to these institutions for quality verification. Companies received immediate feedback on their process and any shortcomings that were identified in terms of quality were reported back to companies within days, including who worked on them again and got them re-checked. The centres gave much-needed regulatory and good quality manufacturing practice guidance to companies, so they could get approval from regulatory agencies for end use. Over 150 companies used this centre of excellence to get their testing kit components validated, leading to the rapid manufacturing of close to one million test kits in a day, within nine months of the May 2020 start of the initiative.
“The CCAMP-InDx is a brilliant example of the platform, infrastructure, and network needed to build large-scale, global diagnostics companies from India”, said Hasmukh Rawal, Managing Director, Mylab Discovery Solutions.
Mylab was one of the first Indian companies to develop a RT PCR test kit that was made in India.
Today, India tests a record of 1.5 million RT PCR tests per day and the kit manufacturers have found a thriving export market that is helping plug the shortage of RT PCR test kits in low- and middle-income countries in Asia and Africa.
Way forward
The rapid production of these kits has led to excess capacity of kits in-country, making way for domestic diagnostic companies to look at export markets. The platform has also led to the creation of diagnostic companies such as MyLabs, Huwel, and NeoDx, all which hold the potential of scientific and commercial success in this space.
Dr Saiyed of C-CAMP says that thanks to this intervention, India was able to avert the high burden of health care costs (via import of expensive kits), and added that the shortage of kits would have led to fewer tests, resulting in poor understanding of the pandemic’s trajectory.
The SOPs put in place by the InDx platform and the CoEs has emerged as a model for any diagnostic company looking for technical and commercial guidance required to succeed in this space. Today, the platform is also helping companies expand in developing other forms of COVID-19 test kits, such as rapid antigen and antibody tests. This platform intends to become the go-to marketplace for companies, researchers, and academic institutions who want to develop and expand their work in other infectious diseases. Its structure also makes it possible for any country across the world to scale up diagnostic tests for another potential infectious disease outbreak.
Supplementary material
Sources
- https://www.statista.com/statistics/1113465/india-coronavirus-covid-19-tests-cumulative/
- https://www.psa.gov.in/about-us
- https://www.ccamp.res.in/indx-indigenous-diagnostics-digital-platform
- https://www.ccamp.res.in/indx-indigenous-diagnostics
- https://www.rockefellerfoundation.org/news/the-rockefeller-foundation-awards-new-grants-to-scale-up-covid-19-testing-in-india/
- https://www.ccamp.res.in/indx-indigenous-diagnostics-centres-of-excellence
