India is among the top 12 destinations for biotechnology worldwide. The industry comprises >2,700 biotech start-ups and >2,500 biotech companies in the country. India has 665 FDA-approved plants the US; 44% of the global abbreviated new drug applications (ANDA) and >1400 manufacturing plants, which are compliant with WHO.
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 Indian biotechnology industry amounted to US$ 63 billion in 2019 and is forecast to reach US$ 150 billion by 2025, with a CAGR of 16.4%. By 2025, the contribution of the Indian biotechnology industry in the global biotechnology market is expected to grow to 19% from 3% in 2017. Biopharmaceutical is the largest segment that contributed ~58% to the Indian biotechnology market in 2019, followed by bio-agriculture, which accounted for 19% and bio-services, which accounted for 15% in 2019. The Indian biologics market is expected to register a CAGR of 22% from 2019 to 2025 to reach US$ 12 billion by 2025.
Bio-services, which accounted for 15% of the biotechnology industry in India, is becoming a leading destination for clinical trials, contract research and manufacturing activities in the country.
Investments and Recent Developments
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 chemical sector are as follows:
Union Budget 2021-22
Under the Union Budget 2021-22, the government outlaid Rs. 1,660 crore (US$ 227.94 million) for biotechnology research and development.
Under the Union Budget 2021-22, the government announced plans to set up nine biosafety level-3 (BSL-3) laboratories through Pradhan Mantri Aatmanirbhar Swasth Bharat Yojana.
Department of Biotechnology
In November 2020, the Government of India allocated the third stimulus package of Rs. 900 crore (US$ 123.26 million) for the ‘Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission’ to the Department of Biotechnology (DBT) for research & development of Indian COVID-19 vaccines. This stimulus package will help accelerate the development of ~5-6 vaccine candidates and ensure that these are brought closer to licensure and introduction in the market.
National Biopharma Mission, ‘Innovate India’ 2017, a DBT programme worth US$ 250 million, aims to bring together industry and academia in order to promote entrepreneurship and indigenous manufacturing in biopharma.
On April 13, 2021, the Union Government approved to streamline and fast-track the regulatory system for COVID-19 vaccines that have been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or those listed in WHO Emergency Use Listing (EUL). This decision is likely to facilitate quicker access to foreign vaccines by India and encourage imports, including imports of bulk drug materials, optimise utilisation of domestic fill and finish capacity, etc.; this will boost vaccine manufacturing capacity and total vaccine availability within the country.
Under Atmanirbhar Bharat 3.0, Mission COVID Suraksha was announced by the Government of India to accelerate the development and production of indigenous COVID vaccines. In May 2021, to augment the capacity of indigenous production of Covaxin under the mission, the Department of Biotechnology, Government of India provided financial support in the form of a grant to vaccine manufacturing facilities for enhanced production capacities, which is expected to reach >10 crore doses per month by September 2021.
Indian biotechnology 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 the flagship programmes such as 'Make in India' and 'Start-up India'.
Increase in the number of biotech incubators will boost research and promote growth of start-ups; this is critical for the success of the Indian biotech industry.
References: Department of Biotechnology, Association of Biotechnology Led Enterprises, BIRAC, Global Bio-India
Note: Conversion rate used in May 2021, Rs. 1 = US$ 0.01365
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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