By Kiran Mazumdar-Shaw
The COVID-19 pandemic has proven that science can rescue humanity. And for science to prosper you need to have dedicated national agencies that are relentlessly driving the agenda of science. Since its inception in 1982, The Department of Biotechnology (DBT) has made tremendous efforts in promoting bioscience research, translational education and entrepreneurship. From its initial mandate to identify priority development areas in biotechnology, it has been instrumental in creating an academic ecosystem to harness talent, initiating a regulatory framework for the industry, promoting entrepreneurship through the Biotechnology Development Fund and nurturing industry-academia partnerships.
Over the last 18 months, in the fight against COVID-19, DBT and its Public Sector Undertaking, Biotechnology Industry Research Assistance Council (BIRAC), have been at the forefront strategizing to fast-track vaccine development, diagnostics, drug repurposing, therapeutics and other COVID related interventions.
DBT has assumed a profile similar to that of BARDA (The Biomedical Advanced Research and Development Authority) in the U.S. which provides an integrated approach to the development of vaccines, drugs, therapies and diagnostic tools for public health medical emergencies, including pandemics.
LAYING AN EFFICIENT SUPPORT SYSTEM
Armed with a provision of Rs 900 crore (~USD 126 million), the DBT announced Mission COVID Suraksha to support the development of a comprehensive ecosystem to devise a safe, efficacious and affordable vaccine for COVID-19. This included providing grants for candidate vaccine platforms, facilities for animal studies, immunoassay labs and clinical trial sites. The Mission also entailed enhancing capabilities through regulatory guidance, support on process and cell line development and GMP manufacturing.
Eleven clinical trial sites, each with access to a cohort of 50,000 to 100,00 healthy volunteers, were readied to help developers test vaccine candidates quickly. Resources such as state-of-the-art infrastructure, well-trained staff, harmonised protocols and a network of laboratories for immunogenicity testing were also provided.
The DBT also established four biorepositories at the Autonomous Institutes it supports to facilitate sharing of archived biospecimens and enable accelerated COVID-related research and innovation. The goal was to draw valuable insights into the evolution and epidemiology of the pandemic from the high volumes of genomic data generated and to use it to evaluate control strategies (drugs, vaccines) and refine diagnostic assays. These efforts led to the successful sequencing of 1,000 SARS-CoV-2 genomes in a record three months. The Indian SARS-CoV-2 Genomic Consortium (INSACOG) was also launched to ascertain the status of new mutant variants of SARS-CoV-2 in the country. The aim is to establish sentinel surveillance for early detection of genomic variants that are of public health concern.
ACCELERATING INDIGENOUS SOLUTIONS
Recognizing India’s enormous scientific prowess to come up with breakthrough discoveries of lasting value for humanity, DBT prioritized the development of indigenous medical solutions for COVID-19. The efforts of DBT and BIRAC under their COVID-19 Research Consortium led to the facilitation of nearly 80 industry and academic collaborations ranging from diagnostics, discovery of therapies, repurposing of drug, support for vaccine development etc.
Through its National Biopharma Mission, DBT is supporting the development of the nation’s first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by Zydus Cadila. It has lent its support to the Phase III trial of a recombinant BCG vaccine candidate by Serum Institute of India. DBT provided seed funding for Gennova’s next-generation, mRNA-based vaccine manufacturing platform. It is also funding Bharat Biotech’s project to develop a COVID-19 vaccine based on an inactivated rabies virus platform and Aurobindo Pharma’s recombinant vesicular stomatitis (VSV, VesiculoVax) vaccine delivery platform.
With grants from the DBT, the current production capacity of Bharat Biotech’s in-market vaccine, Covaxin, is expected to reach nearly 10 crore doses a month by September this year.
EXPANDING PARTNERSHIPS
To support vaccine development activities in partnering countries, the PACT (Partnerships for Accelerating Clinical Trials) programme is being implemented by BIRAC and Clinical Development Services Agency (CDSA) under the aegis of the National Biopharma Mission and Ind-CEPI Mission of DBT.
In alliance with the PM-Task Force, DBT is supporting vaccine development efforts through the PM CARES Fund.
DBT also partnered with AYUSH to launch a joint network programme, involving DBT AIs and National Medicinal Plants Board (NMPB) to harness the potential of indigenous medicinal plants for development of plant-based therapeutics. Over 50 plants will be screened for this purpose.
SCALING UP CAPACITY
To ramp up testing in the country, BIRAC supported Pune-based Mylab develop India’s first indigenous RT-PCR test kits for the novel coronavirus. A locally developed diagnostic kit helped India ramp-up testing significantly and contributed to the battle against COVID-19.
DBT will also provide financial support to six projects that support capacity building for vaccine development, including strengthening of facilities for conducting animal studies and immunological assays.
In addition, DBT and Regional Centre for Biotechnology (RCB), Faridabad have set up an in vitro cell culture-based assay to test the antiviral activity of potential molecules against SARS-CoV-2. Further, a total of 19 sites have been identified and are being developed into GCP compliant sites and will enhance the capacity to conduct human clinical trials for anti-COVID therapies.
PROMOTING INDIGENOUS CAPACITY BUILDING THROUGH ENTREPRENEURSHIP
Realising the importance of how entrepreneurs can use innovation to help the world overcome many of the current challenges we face because of the pandemic, DBT has increased support to start-ups to make them self-reliant through the National Biomedical Resource Indigenisation Consortium (NBRIC) and BIRAC. Constituted by DBT, NBRIC brings together academia, industry, start-ups and MSMEs to facilitate the indigenous capacity building of reagents, raw materials and new technology platforms for diagnostics, vaccines and therapeutics for COVID-19 and beyond.
To harness the power of entrepreneurship, BIRAC’s incubator network also supported over 100 companies engaged in providing COVID solutions. Over 10,000 start-ups, entrepreneurs and stakeholders were connected through online webinars and consultations.
BIRAC supported 20 in-market products from start-ups which covered solutions such as hand-held diagnostic devices, tele ECG, digital stethoscopes, fetal heart rate monitors and intrapartum monitoring tools.
CONCLUSION
The ecosystem created over the last few decades by DBT has enabled biotechnology in India to grow from a fledgling sector to a sunrise industry. However, it is in the fight against the pandemic that the institution has really delivered beyond its mandate and done so at a fraction of the budget of its counterpart BARDA which was awarded USD 3.5 billion at the outset.
Both organizations have funded and supported high risk research due to which innovations could be translated into treatment regimens in record time to curb the pandemic.
The article first appeared in ET Prime on June 12, 2021.
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