Biotechnology industry in India

Introduction

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).

Market Size

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. In the Indian biotechnology market, Biopharmaceutical, which is the largest segment, accounted for ~62% in 2020 and ~58% 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 2020, 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:

• In November 2021, Union 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 inaugurated a new Biotechnology Centre for Northeast tribals in the remote area of Kimin (Arunachal Pradesh).
• In November 2021, Union 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 launched a pan-India Star College Mentorship Programme for young innovators supported by the Department of Biotechnology.
• India could restart deliveries of Covid-19 shots to global vaccine-sharing platform COVAX in November-December 2021 for the first time since April 2021. The World Health Organization (WHO), which co-leads COVAX, has been pushing India to resume supplies for the programme, particularly after it sent ~4 million doses to its neighbours and allies in October 2021.
• The Government of India and Karnataka government funded Biomoneta, a start-up that developed an air decontamination technology, which eliminates airborne COVID-19 virus with 99.9999% efficiency in any closed setting.
• In October 2021, India and Colombia exchanged views on possible scientific cooperation in the biotechnology sector as Columbia is willing to tie-up in the areas of vaccines, biosimilars and medical devices.
• In October 2021, Biological E has sought permission from Drugs Controller General of India (DCGI), to conduct phase-III clinical trials for its COVID-19 vaccine. Corbevax is a single booster dose for people fully vaccinated with the Covishield or Covaxin vaccines.
• The subject expert committee of India’s Central Drugs Standard Control Organisation recommended Serum Institute of India to conduct phase II and III clinical trials of Covovax on children aged 7-11 years.
• In August 2021, the Central Council for Research in Siddha (CCRS) introduced ARIVU, an initiative to motivate academia and industry to carry out research to advance value-chain in industries such as biotechnology and nanotechnology.
• In August 2021, Bharat Biotech received World Health Organisation’s (WHO) prequalification approval for Rotavac 5D for prevention of rotavirus diarrhoea.
• In August 2021, Glenmark Pharmaceuticals collaborated with SaNOtize Research, Canadian biotech company, for manufacturing, marketing and distributing nitric oxide nasal spray (NONS) to treat COVID‐19 in India and other Asian markets.
• In July 2021, Union 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 launched ‘Biotech-PRIDE’ (Promotion of Research and Innovation through Data Exchange) guidelines to support information exchange and encourage research and innovation in various research groups in India.
• In May 2021, Indian Immunologicals Limited (IIL) and Bharat Immunologicals and Biologicals Corporation (BIBCOL) inked technology transfer pacts with Bharat Biotech to develop the vaccine locally to boost India's vaccination drive. The two PSUs plan to start the production of vaccines by September 2021.
• In April 2021, the Department of Biotechnology (DBT), Ministry of Science & Technology, approved additional funding towards clinical studies for India’s ‘first-of-its-kind' mRNA-based COVID-19 vaccine, HGCO19, developed by Pune-based Gennova Biopharmaceuticals Ltd.
• In April 2021, Drug Controller General of India (DCGI) gave a restricted emergency use approval to the Zydus Cadila’s ‘Virafin’ for treating patients with moderate COVID-19 symptoms. Virafin is a pegylated interferon alpha-2b(PegIFN), which when subcutaneously injected to the patient in the early stages of infection, resulted in their faster recovery.
• In April 2021, the CSIR-CMERI, Durgapur, indigenously developed an ‘oxygen enrichment technology’, which may be effective for treating COVID-19 patients. The oxygen enrichment unit can deliver medical air in the range of up to 15 litres per minute, with oxygen purity of >90%.

Government Initiatives

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.

Atal Jai Anusandhan Biotech Mission is 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 the emerging biotechnology enterprises to undertake strategic research and innovation.
• In October 2021, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, has established a research unit funded by the Biotechnology Industry Research Assistance Council (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. The Innovation Incubation Centre (SRIIC) is supported by Bio-NEST programme of Biotechnology, BIRAC.
• HempStreet became the first medicinal cannabis firm to win BIRAC grant in India, in July 2021.
• DBT-BIRAC funded SanMitra 1000 HCT, a hand-cranked dual powered (grid+hand cranked) defibrillator, was developed by Jeevtronics Pvt. Ltd. in July 2021. Experts believe that this low-cost, light-weight device is more reliable than standard defibrillators as it can be used in regions where electricity is absent.

Biotech Initiatives

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.

Clinical Trials

• In November 2021, INOVIO announced that it has received authorisation from India's Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in India. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the trials.
• In November 2021, US-based Akston Biosciences announced that it will start the clinical trial of its second-generation Covid-19 vaccine ‘AKS-452’ in India soon.
• Bharat Biotech and the Indian Council of Medical Research (ICMR) are exploring Covaxin clinical trials in Bangladesh, which is expected to boost its (Covaxin) international recognition.
• The Union Ministry for Health and Family Welfare introduced new Drugs and Clinical Trials Rules, 2019, changing the regulatory landscape to approve new drugs and conduct clinical trials in the country.
• The Indian Council of Medical Research (ICMR) selected 12 institutes for the clinical trials of the country’s first indigenous COVID-19 vaccine.
• In 2020, ICMR developed indigenous COVID-19 vaccine (BBV152 COVID) in partnership with Bharat Biotech International Limited.
• Cipla, Dr. Reddy's Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals joined forces to conduct clinical trials of the investigational oral antiviral medication, Molnupiravir, for the treatment of mild COVID-19 in July 2021.

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 necessary infrastructure support.
• These biotechnology parks offer facilities to scientists, and small & medium sized enterprises (SMEs) for technology incubation, technology demonstration and pilot plant studies to accelerate the commercial development of biotechnology.
• The government, at present, supports nine biotechnology parks in various states with the bulk being in the southern region of the country.

COVID-19 Vaccination

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.

In November 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 of any severity.

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.

Road Ahead

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 November 2021, Rs. 1 = US$ 0.01336

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.