National Reagents Consortium: A Cluster approach for promoting high-quality, affordable and indigenous manufacture of diagnostics and reagents
The COVID-19 pandemic has brought to the forefront an unprecedented challenge of catering to the national need for diagnostic kits in India in a short period of time. It has compelled us to re-evaluate our strengths and resources needed to tackle an issue of this magnitude. For a country like India with a billion-plus population, rapid and effective testing is an important step in handling the crisis. The enormous challenge of a severe shortage of COVID-19 diagnostic testing kits has hampered the country’s plans for large-scale testing of the population. This shortage of kits is primarily caused by a lack of supply of high quality reagents that go into the manufacturing of these kits. Several factors are responsible for this supply-chain obstruction such as high global demand; price and supply risk of imported products; and quality, capability and capacity issues of the local manufacturers. Indigenous manufacturing of kit reagents and components is an integral link in the value chain of diagnostic manufacturing. To address the problem at a national level, the office of Principal Scientific Adviser (PSA) to Government of India (GoI) has led the creation of public-private partnership models for a nation-wide capacity-building programme for diagnostics through city clusters including cities such as Bengaluru, Delhi, Hyderabad and Pune. Emphasising the need for such an initiative, Prof. K. VijayRaghavan, PSA to GoI said, “Building capabilities and capacities of indigenous manufacturers of reagents and kits will ensure that we are able to effectively implement the testing strategies for our population. The programme will also go a long way in making India self-sufficient in the area of molecular diagnostics.”
The Hyderabad City Cluster (HCC) took up the initiative to form the Reagent Consortium and fill the gaps in the affordable manufacturing of indigenous diagnostics and reagents. Hyderabad is strongly positioned to lead the way by utilising its existing expertise in the life sciences sector. The Reagent Consortium is being led by CSIR-CCMB (Centre for Cellular and Molecular Biology), a premier research institute under the CSIR umbrella, supported by RICH (Research and Innovation Circle of Hyderabad), the nodal entity of the HCC. Other members of the Consortium will be the MSME reagent manufacturers, and testing and validation agencies. CCMB has been involved in the national COVID-19 mitigation activities from the very early stage of the pandemic and has been at the forefront of testing, training, kit validation, anti-viral drug screening, vaccine collaborations and development of diagnostic kits. CCMB is also one of the ICMR-approved testing and validation centres and a national repository for COVID-19 patient samples. With its large pool of researchers and its first-hand experience with COVID19-related projects, CCMB is well-equipped to support the national plan of development of diagnostic reagents and kits. The Consortium has initially focused on the RT-PCR diagnostic platform. It has identified MSME manufacturers of components and reagents. The RT-PCR technique finds wide applications 2 in research, diagnosis and detection of several diseases. A target of 500,000 reactions for COVID-19 testing has been set for the pilot phase of this programme, which will be scaled up to enable production of 10 million kits per month within a year of beginning the programme. The pilot phase of the programme, which will run for 6 months, has been funded by FIND India (Foundation for Innovative New Diagnostics) with support from Bill and Melinda Gates Foundation.
Dr Rakesh Mishra, Director of CSIR-CCMB said, “Bringing together suppliers of biotechnology reagents to meet the national emergencies is critical and the cluster is helping in truly aggregating the stakeholders in the diagnostic space.” Highlighting the importance of a collaborative network, Ajit Rangnekar, Director-General of RICH said, “The prior creation of clusters helped us to quickly plan and organise our activities around this initiative, and put in place the required structures.” The programme has received an enthusiastic response from the MSME players. Dr Sudarshan Reddy, Founder and CEO of Oncosimis Biotech, a company incubated at AIC-CCMB said, “India undoubtedly needs more high-quality, affordable testing to safely re-open the economy. I appreciate the efforts of CSIR-CCMB in developing selfsustainable COVID-19 testing solutions by providing the much-needed insights and guidance to bring out better products.” The programme will help expand India’s R&D capabilities by making low-cost, high-quality reagents readily available with creation of a streamlined network of the entire value chain. The programme is a step in the right direction to respond to the Aatmanirbhar Bharat (Self-reliant India) call of Hon’ble Prime Minister to ensure that the country is well-prepared to handle future crises. For any further queries on the initiative, feel free to connect with email@example.com at the Office of the Principal Scientific Adviser (PSA), Government of India.
Guarding the Guardians: Helping India’s ‘Corona Warriors’ to take on COVID-19 with Mentored Laboratory Training
Currently leading the global daily numbers for new COVID-19 cases, India is rapidly scaling up its testing network to arrest the pandemic’s spread. The number of private and public sector laboratories empanelled by the Indian Council of Medical Research (ICMR) for COVID-19 testing has increased from 19 in early March to 1,774 as of September 20, 2020. Together, these labs are conducting around 1 million tests every day. However, ICMR looks to further bolster this pan-India testing apparatus. Major challenges are dearth of professionals with adequate knowledge of molecular biology methods, biosafety requirements, and practical bench skills required to work with highly-infectious diseases. The need-gap is staggering. To begin with, it leaves the health and personal safety of the first line of India’s defence against the novel coronavirus highly vulnerable. Inadvertent mistakes made during sample collection, transportation, testing, and reporting also increase the risk of accelerating the spread of the disease as well as lower the accuracy of the tests.
This is where the Mentored Laboratory Training for COVID-19 and Infectious Diseases launched by the Foundation for Innovative New Diagnostics – along with Tata Institute of Fundamental Research, PanIIT Alumni Reach for India, and National Institute of Immunology – steps into the picture. The multi-pronged COVID-19 diagnostic training programme aims to empower trainees with the basic knowledge and practical bench skills of molecular biology methods that can be implemented for COVID-19 diagnostics and other infectious diseases. Speaking on the need for such an intervention, Prof. K. VijayRaghavan, Principal Scientific Adviser to the Government of India added, “With India’s ‘Corona Warriors’ leading the fight against the pandemic, it is our duty to ensure they have the requisite knowledge and skills to execute this task. Hence, we felt the need to tie up a befitting, high quality project and wish successful execution of the same across India with the help of the best in this field.” Enabled by the Office of the Principal Scientific Adviser, Government of India, with support from the Bill & Melinda Gates Foundation, the training will be carried out through a hybridised online/offline module and will comprise five ‘Workstreams’. These ‘Workstreams’ will include online training coursework, weekly mentoring workshops with regional and national experts across multiple associated functions, upskilling sessions at COVID-19 testing sites, pre-service training on basic molecular biology, and online query support from experts for troubleshooting. This integrated approach will help to create a skilled laboratory workforce that can carry out sustained, high-quality COVID-19 sample processing, testing, and reporting – without compromising the accuracy of the results or the biosafety of India’s brave ‘Corona Warriors’. For any further queries on the initiative please feel free to connect with Sapna.firstname.lastname@example.org at the office of the Principal Scientific Adviser, Government of India.
India to double its testing capacity - InDx - a new project facilitated by Office of the PSA
A major project has been launched to indigenously manufacture, in bulk quantities and at much lower costs, all reagents needed for RT-qPCR-based and other molecular methods of diagnostics of COVID-19. The Rockefeller Foundation has provided financial support for the project executed by the Bangalore Life Science Cluster, which would improve access to COVID-19 diagnostics across the country. The COVID-19 pandemic has been unprecedented and has severely affected countries across the world. India, with its population of more than 1.3 billion, is scaling to test rapidly and widely across its population. Considering the nature of the virus, its mode of transmission and nonavailability of effective drugs and vaccines, the best way to check the spread of the infection and save lives (and livelihoods) is by testing larger number of individuals and isolating the positive cases. In this context, there is an urgent need to scale up the production of RT-PCR and other molecular diagnostic testing kits in the country. The newly launched project called Indigenisation of Diagnostics (InDx), anchored at Centre for Cellular and Molecular Platforms (CCAMP), aims to build a robust supply-chain network of Indian MSMEs capable of producing reagents that go into a testing kit as well as manufacture testing kits. The project involves identifying bottlenecks in the supply-chain network, short-falls in quality levels and gaps in the ability of these MSMEs to scale-up. The project would handhold MSMEs in meeting both quality and quantity such that the network would be able to put together a million indigenous kits a day. The project employs a dynamic digital supply-chain platform developed pro-bono by Tata Consultancy Services (TCS). In addition, the project envisages providing support to maintain a sustainable business plan for the consortium with the help of experts in the field.
Prof K VijayRaghavan, the Principal Scientific Advisor to the Govt of India, who is overseeing India’s efforts of indigenisation of biomedical products, said “this is a multipurpose project addressing not only the COVID-19 crisis but aimed at helping MSMEs to expand their business opportunities and to improve the overall healthcare system by developing more high quality, but low cost molecular diagnostics. Important collaboration with The Rockefeller Foundation will enable our MSMEs to meet global standards.” “The generous support by The Rockefeller Foundation and enthusiastic response by MSMEs to participate in the proposed supply-chain network has given the confidence that we would be able to meet the target of one million kits per day within the next few months,” says Dr Taslimarif Saiyed, CEO of CCAMP, who heads the project at Bangalore Life Science Cluster. Prof Satyajit Mayor, Director of NCBS, Bangalore, an advisor to the project says “This initiative may help innovations in our ability to meet global quality and thereby our MSMEs may not only be able to serve the Indian market and be able to export to the other needy countries at very competitive prices. We hope to expand the project to include other new molecular diagnostic methods such as Lateral Flow Assays or LAMP-based assays for COVID-19 testing, newly developed saliva-based sampling tests, which are point of care tests and also scalable to test at scale.” “Strengthening India’s ability to develop fully indigenous diagnostic kits is expected to improve the entire healthcare system as affordable molecular diagnostics may soon be available for other diseases, particularly cancer and rare tropical diseases” says Prof. LS Shashidhara, Dean (Research) at Ashoka University, who is also an advisor to the project.
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Office of PSA releases simple guide to building positive mental health
As news about SARS-CoV-2 (COVID-19) dominates the headlines and public concern is on the rise, taking care of mental health is as important as looking after the physical health. Good mental health and positive wellbeing can help individuals better cope with the COVID-19 threat and the uncertainty it is creating. Resilience is the process of finding healthy ways to adapt and cope with adversity and distress. Building resilience can be the key to helping the individuals get through the COVID-19 pandemic crisis and its aftermath. It can help protect one from various mental health symptoms, such as depression, anxiety and traumatic stress. It can also help those who already have mental health conditions cope better. Prior tragedies have shown the power of resilience. Knowing this and how to build resilience can be a source of great hope for many people. In fact, people can even experience emotional growth after a tragedy. In association with Armed Force Medical College (AFMC) Pune, Office of the Principal Scientific Adviser brings forth a guideline book to build positive mental health. This e-book is published in Hindi as well as English to reach out to the larger audience.