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 pharmaceutical sector are as follows:

• In August 2023, the Department of Biotechnology (DBT) and the United States-National Science Foundation (US-NSF) announced to build bilateral collaborations between India and the USA through this Implementation Arrangement
• In August 2023, Technology Development Board (TDB) and the Department of Science & Technology (DST) partnered with Chemlife Innovations for the Innovative Bio-Trace Minerals Project to enhance livestock productivity, optimize feed and fodder resources and infuse technology into livestock management
• In July 2023, Aurigene Pharmaceutical Services to set up US$ 40 million facility in Hyderabad
• In July 2023, India and Argentina agreed to a bilateral exchange of young researchers and Startups, particularly in the field of Biotechnology and Agriculture
• In July 2023, Biocon Biologics launched a biosimilar version of AbbVie's top-selling biologic Humira (generically called adalimumab) in the US market under the brand name HULIO
• In May 2023, India and Israel will strengthen their connection in areas such as innovation and start-ups, ushering in a new period of deeper bilateral cooperation
• Union Minister Dr. Jitendra Singh inaugurates the Northeast's first International Biotech Conclave
• In February 2023, Serum Institute of India announces centre of excellence in Hyderabad to tackle future pandemics
• In February 2023, Bristol-Myers Squibb intends to invest US$ 96.69 million (Rs. 800 crore) in establishing a cutting-edge centre in Telegana to boost its global medical development and IT capabilities
• In February 2022, DBT inked a five-year MoU with the Indian Council of Medical Research (ICMR) and IAVI.
• In January 2023, Yashoda Super Specialty Hospital will invest about US$ 60.42 million (Rs. 500 crore) in establishing a Biotech Park and 300-bedded hospital in Greater Noida, while Yashoda Medicity will invest US$ 96.67 million (Rs. 800 crore) in Ghaziabad to set up a new hi-tech hospital with a capacity of 1200 beds.
• In January 2022, BIRAC made a major contribution to developing the world's first Intranasal vaccine for Covid through Bharat Biotech International Limited (BBIL).
• Investment in India's bioeconomy increased 400%, reaching US$ 507.77 million (Rs. 4,200 crore) in 2022 from US$ 1.20 million (Rs. 10 crore) in 2014.
• On November 10, 2022, 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 February 2023, CrisprBits, a biotechnology startup and one of the first Indian companies using CRISPR, raised US$ 250,000 in the pre-seed funding from a US-based VJ Group, for product development, team expansion, and for research and development.
• 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.

• December 2022:
  • Union Health Minister Dr. Mansukh Mandaviya and , Minister of State, Ministry of Science and Technology, Earth Science, Personnel, Public Grievances, Pensions, Space and Atomic Energy Minister, Dr. Jitendra Singh launched the world's first COVID-19 intranasal vaccine, iNCOVACC, which has been developed by Bharat Biotech.
  • Bengaluru-headquartered Centre for Cellular and Molecular Platforms (C-CAMP), an initiative supported by the Department of Biotechnology, announced a next-generation Indo-Dutch bilateral collaboration to address challenges posed by Antimicrobial Resistance (AMR).

• 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.