PRODESK ENGINEERING MANPOWER SOLUTIONS

India is among the top 12 destinations for biotechnology worldwide. The Department of Biotechnology (DBT), under the Ministry of Science and Technology, has placed great emphasis on developing an ecosystem for the development of excellence and research in a variety of biotechnology fields in India.

By creating and using a variety of tools at its disposal, such as vaccines, antivirals, diagnostic tests, and other tools, the biotechnology industry has been at the forefront of the fight against the Covid-19 pandemic. The pandemic has assisted the country in setting up the ideal ecosystem for production, sourcing, and exporting medical devices and vaccines.

The number of biotech startup registrations has surged throughout the nation in 2021, with around 1,128 new startups registered, which is the highest in a single year since 2015. Estimates put the total number of biotechnology startups at 5,365, as of 2021. The number of startups is expected to touch 10,000 by 2024.

India has 665 FDA-approved plants in the US; 44% of the global abbreviated new drug applications (ANDA) and more than 1,400 manufacturing plants, which are compliant with WHO’s requirements. The country is also the world’s third-largest producer of recombinant Hepatitis B vaccine, and second-largest producer of BT cotton (genetically modified pest resistant plant cotton).

The size of India’s bioeconomy is estimated to be at US$ 80.12 billion as of 2021, which is a 14.13% growth over US$ 70.2 billion in 2020. India’s bioeconomy contributes 2.6% to India’s GDP, as of 2021.

Nearly a fifth of India’s bioeconomy, standing at US$ 14.56 billion, was due to the Covid-19 vaccination and testing drive. Covid-19 vaccines had a worth of US$ 8.7 billion, whereas testing cost US$ 5.9 billion. 1.45 billion Covid-19 doses were administered in 2021, and 1.3 million Covid tests were taken every day.

The largest portion of the Indian bioeconomy continues to be accounted for by biopharma. Biopharma accounted for 49% share of the bioeconomy, and its total economic contribution was estimated at US$ 39.4 billion.

From 2015-2020, India’s biotechnology industry grew rapidly, doubling from US$ 30.2 billion to US$ 70.2 billion in five years. As of 2021, India’s biotech industry clocks in about US$ 12 billion in annual revenue. The Indian biotechnology industry is expected to reach US$ 150 billion by 2025. By 2025, the contribution of the Indian biotechnology industry to the global biotechnology market is expected to grow to 19%. The Indian biologics market is forecasted to reach US$ 12 billion by 2025, at a CAGR of 22%.

India allows 100% FDI under the automatic route (a non-resident or Indian company will not require any approval from the government) for greenfield pharmaceuticals and manufacturing medical devices. Some recent developments/investments in the Indian pharmaceutical sector are as follows:

• On November 10, Minister of State (Independent Charge) Ministry of Science and Technology; Minister of State (Independent Charge) Ministry of Earth Science; MoS PMO, Personnel, Public Grievances, Pensions, Space and Atomic Energy, Dr. Jitendra Singh, inaugurated India’s first national repository for life science data - ‘Indian Biological Data Center’ (IBDC) at Faridabad, Haryana.
• In August 2022, Eyestem, a Bengaluru-based cell therapy company, raised US$ 6.4 million in a Series-A funding round to create cell therapy products.
• In June 2022, Serum Institute of India partnered with US company Novavax to manufacture their Covid vaccine (NVX-CoV2373) for the US market.
• In June 2022, Thrissur-based biotechnology startup Zaara Biotech received an undisclosed amount of investment from US-based Transcend International to set up its Algal seaweed technology facility in the US.
• In FY22, India’s pharmaceutical exports touched Rs. 1.8 trillion (US$ 23.04 billion). Formulations and biologicals account for 73.31% of the country's total exports, followed by bulk drugs and drug intermediates.
• February 2022:
  • ARISTA Biotech announced its plans to set up a cleanroom environment production facility in Hong Kong to manufacture Covid-19 rapid antigen testing kits to serve the rapidly-increasing local demand.
  • Gennova Biopharmaceuticals, who were conducting phase 2 and 3 trials of India’s first indigenous mRNA vaccine on humans, have finished those trials. The data is currently being reviewed by the Drug Controller General of India (DCGI).
  • American biotech company Vaxart announced plans to start phase II clinical trials of its oral tablet-based Covid-19 vaccine in India soon.
• In November 2021:
  • Karnataka announced its aim to be a US$ 50 billion bio-economy by 2026, from the current US$ 22.6 billion.
  • Serum Institute of India restarted deliveries of Covid-19 shots to global vaccine-sharing platform COVAX for the first time since April 2021.
  • INOVIO announced that it has received authorisation from India's Central Drugs Standard Control Organization’s (CDSCO) Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in India.
  • The World Health Organization (WHO) issued an emergency use listing (EUL) for Bharat Biotech’s Covid-19 vaccine COVAXIN. It was found to have 78% efficacy against Covid-19 virus of any severity.
  • US-based Akston Biosciences announced that it will start clinical trials of its second-generation Covid-19 vaccine ‘AKS-452’ in India.

The Government of India has taken multiple initiatives to make India competitive internationally in biotechnology research, innovation, entrepreneurship, and industrial growth. Some of these are:

• On November 14, India and Finland agreed to advance bilateral collaboration and expand cooperation in sectors like digital education, future mobile technologies, biotechnology, and the digital partnership in ICT.
• In August 2022, Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr. Jitendra Singh, announced 75 "Amrit" Grants worth Rs. 10-15 crore (US$ 1.22-1.83 million) for biotech projects involving startups, industry, academia, and research organisations working together.
• On June 9, Prime Minister Mr. Narendra Modi inaugurated the Biotech Startup Expo – 2022. The event was being conducted to commemorate BIRAC's tenth anniversary since its foundation. The Expo's theme was 'Biotech Startup Innovations: Towards AatmaNirbhar Bharat. The Expo showcased 75 successful startups supported by BIRAC, 75 Specialized Biotech Incubation Centres supported by BIRAC, 21 IITs/ universities, 50 successful startups supported by DPIIT and various national and international programs of BIRAC.
• February 2022: In the Union Budget 2022-23, the Department of Biotechnology was allotted Rs. 2,581 crore (US$ 343.56 million) for developing basic infrastructure, genetic engineering, technologies and bioinformatics, agriculture biotechnology, and training skilled professionals.
• In November 2021, Dr. Jitendra Singh, Minister of Science & Technology, Earth Sciences, MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, inaugurated a new Biotechnology Centre for Northeast tribals in the remote area of Kimin (Arunachal Pradesh). He also launched a pan-India Star College Mentorship Programme for young innovators supported by the Department of Biotechnology.

Department of Biotechnology:

• Atal Jai Anusandhan Biotech Mission was implemented by Department of Biotechnology (DBT), Ministry of Science and Technology. The purpose of this mission is to address the challenges of maternal and child health, antimicrobial resistance, vaccines for infectious disease, food and nutrition, and clean technologies.
• In October 2021, the Department of Biotechnology launched a ‘One Health’ consortium that will survey important bacterial, viral and parasitic infections of zoonotic as well as transboundary pathogens in the country. The consortium consists of 27 organisations and is led by the DBT-National Institute of Animal Biotechnology, Hyderabad.

BIRAC

• Biotechnology Industry Research Assistance Council (BIRAC) established by the Department of Biotechnology (DBT) is aimed at strengthening and empowering emerging biotechnology enterprises to undertake strategic research and innovation.
• In February 2022, BIRAC invited proposals for development, validation and pre- commercialization of products/ technologies in the areas of healthcare, energy and environment, veterinary sciences and aquaculture, agriculture and secondary agriculture.
• In October 2021, Jawaharlal Institute of Postgraduate Medical Education and Research in Pondicherry established a research unit funded by BIRAC to undertake clinical trials of new Covid-19 vaccines that are currently in their development stage.
• In October 2021, BioNEST Bioincubator, a healthcare innovation incubation centre, was inaugurated at the Sri Ramachandra Institute of Higher Education and Research in Chennai, Tamil Nadu.

Biotech Parks:

• Biotechnology Parks and Incubators are established across the country by the Department of Biotechnology (DBT), under the Ministry of Science and Technology, to translate research into products and services by providing the necessary infrastructure support.
• These biotechnology parks offer facilities to scientists, and SMEs for technology incubation, technology demonstration and pilot plant studies to accelerate the commercial development of biotechnology.
• The government supports nine biotechnology parks in various states with the bulk being in the southern region of the country.

The Indian biotechnology industry is built on entrepreneurship, innovation, developing domestic talent and demonstrating value-based care. Given the long history of diseases in India, the country has accumulated years of experience and scientific knowledge to prevent and treat them. India is working to boost the biotechnology sector under various flagship programmes such as 'Make in India' and 'Startup India'.

It is expected that the bioeconomy in the country will reach the US$ 150 billion mark by 2025 and US$ 270-300 billion by the year 2030. It is expected to contribute to roughly 3.3–3.5% of the country's GDP, up from 2.8% in 2021.

Both consumption and exports of diagnostic and medical devices are expected to increase significantly in India. With the help of recombinant and biosimilar products, the therapeutics sector is predicted to generate US$ 15 billion in bioeconomic activity by 2025.

Increase in the number of biotech incubators will boost research and promote the growth of start-ups, which is critical for the success of the Indian biotech industry. The biotechnology sector, mainly due to its multidisciplinary approach, holds the potential to provide an array of solutions for challenges in various sectors such as health, agriculture, environment, energy and industrial processes.