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India is a Biotech Growth Engine:
With a 3 percent stake in the global biotechnology sector, India is one of the top 12 destinations for biotechnology in the world. The industry is critical to India's goal of becoming a $5 trillion economy by 2024.
As the world's leading supplier of DPT, BCG, and measles vaccines, the sector plays a critical role in the global vaccine market, contributing 70 percent of WHO's vaccines (essential Immunization Schedule). On the Global Innovation Index, India is ranked 48th.
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India Market Overview:
The Indian biotechnology industry, which was valued at $70 billion in 2020, is expected to grow to $150 billion by 2025.
The Indian biotech sector is organized into five primary segments: BioPharma, BioAgriculture, BioIndustrial, and a combined section of BioServices that includes BioIT, CROs, and Research Services. There are approximately 5,000 firms in the Indian biotech industry (760 core companies and 4,240 start-ups).
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India was also one of the first countries to establish a Biotechnology Department. Furthermore, the Department has established BIRAC (Biotechnology Industry Research Assistance Council), a non-profit organization whose mission is to strengthen and empower emerging biotechnology businesses to engage in strategic research and innovation by guiding them from concept to commercialization.
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Growth Drivers of the Biotechnology Industry:
1. Population growth
By 2027, India will surpass China as the world's most populated country.
2. Spending on public health is increasing.
Government healthcare spending increased to 1.6 percent of GDP in FY20, up from 1.3 percent in FY16, with a goal of 2.5 percent of GDP by 2025.
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3. Initiatives to strengthen the capacity
Supported by the ‘National Biopharma Mission,' a joint industry-academic effort to improve worker skills.
4. National Biomedical Resource Indigenisation Consortium
Using policy, funding, and the removal of infrastructure and regulatory constraints, India can become a net exporter of affordable diagnostics and testing kits, personal protective equipment (PPE) kits, and vaccines.
5. The government can help improve EoDB by serving as an enabler.
'Make in India,' 'Startup India,' and 'Atmanirbhar Bharat Abhiyan' are all important policy efforts (boosting domestic manufacturing capacity).
Furthermore, the Department has established BIRAC (Biotechnology Industry Research Assistance Council), a non-profit organization whose mission is to strengthen and empower emerging biotechnology businesses to engage in strategic research and innovation by guiding them from concept to commercialization.
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Investments and Recent Developments:
· For greenfield pharmaceuticals and medical device manufacturing, India authorizes 100 percent FDI under the automatic method (a non-resident or Indian business does not need government approval). The following are some recent developments/investments in the Indian chemical sector.
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· Additional funding for clinical research for India's "first-of-its-kind" mRNA-based COVID-19 vaccine, HGCO19, developed by Pune-based Genova Biopharmaceuticals Ltd, was approved by the Department of Biotechnology (DBT) of the Ministry of Science and Technology in April 2021.
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· The DCGI approved a limited emergency usage for patients with moderate COvid-19 symptoms by the Zydus Cadila's 'Virafin' in April 2021. Virgin is an alpha-2b (PegIFN) pegylated interferon, which resulted in a quicker recovery when injecting the patient subcutaneously in the early stage of the illness.
· In April 2021, indigenously, CSIR-CMERI in Durgapur developed an "oxygen enrichment technology" for COVID-19 patients. With a purity of over > 90 percent, the oxygen enrichment machine can supply medical air up to 15 liters per minute.
· The Drugs Controller General of India (DCGI) approved India's first indigenously created DNA vaccine candidate against COVID-19, ZyCoV-D, by Zydus Cadila, to conduct Phase III clinical trials in January 2021. The National Biopharma Mission (NBM), which is sponsored by BIRAC and the Government of India's Department of Biotechnology, has backed the applicant.
· Bharat Biotech expects to produce 700 million doses of its COVID-19 vaccine in January 2021. The company announced that four facilities will be built, with plans to produce 200 million doses in Hyderabad and 500 million doses in other cities.
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