India is among the top 12 destinations for biotechnology worldwide. The industry comprises around 5000 biotech companies, with 4,240 being start-ups and 760 being core biotech companies, with the number of startups expected to touch 10,000 by 2024. There are 60 BIRAC-supported bio-incubators in India.
India has 665 FDA-approved plants in the US; 44% of the global abbreviated new drug applications (ANDA) and more than 1400 manufacturing plants, which are compliant with WHO’s requirements.
As of February 2022, the Department of Biotechnology has 2,143 ongoing projects.
The biotechnology sector is divided into five segments - biopharmaceuticals, bio-services, bio-agriculture, bio-industrial and bio-IT.
The Indian bioeconomy grew from US$ 62.5 billion in 2019 to US$ 70.2 billion in 2020 at a growth rate of 12.3%.
The Indian biotechnology industry, which stood at US$ 63 billion in 2019, is expected to reach US$ 150 billion by 2025, with a CAGR of 16.4%. By 2025, the contribution of the Indian biotechnology industry to the global biotechnology market is expected to grow to 19%. In the Indian biotechnology market, biopharmaceuticals is the largest segment, accounting for 62% share in 2020.
As of 2021, India’s biotech industry clocks in about US$ 12 billion in annual revenue.
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.
- In 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.
- India administered the world’s first DNA vaccine – ZYCOV-D in Patna, which was developed by Ahmedabad-based vaccine manufacturer Zydus Cadila.
- The Malaysian Drug Control Authority (DCA) approved Bharat Biotech’s Covaxin to be used in Malaysia.
- DCGA of India granted restricted emergency use authorisation to Biological E's Covid-19 vaccine Corbevax for kids in the 12-18 years age bracket.
- As part of 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.
- 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 January 2022, Bharat Biotech received permission from the DCGI to start trials of its intranasal booster dose in India.
- 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.
- 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.
- In October 2021, drug firm AstraZeneca launched a clinical data and insights division in Bengaluru, India, for data-related management of its clinical trials.
- In November 2021, Minister of Science & Technology Dr. Jitendra Singh 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.
- Atal Jai Anusandhan Biotech Mission was implemented by Department of Biotechnology, 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, 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.
- Department of Biotechnology has initiated the ‘National Biotechnology Parks Scheme’, proposed to create an ecosystem to absorb start-ups and give them a platform to scale their R&D activities in collaboration with the state government and industry.
- Biotechnology Parks and Incubators are established across the country by the Department of Biotechnology, 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.
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 'Start-up India'.
Increase in the number of biotech incubators will boost research and promote 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.