Biotechnology

Summary
  • The Biotechnology industry in India is divided into the following segments – Biopharmaceuticals, Bio-services, Bio-agriculture, Bio-Industrials and Bio-IT.
  • India’s Bio-Economy is on way to achieve USD 150 bn target from the current USD 70 bn to contribute effectively to PM’s vision of a USD 5 tn economy by 2024-25.*
  • Bioeconomy is likely to touch 150 bn dollars by 2025 and over 300 bn dollars by 2030.*
  • Eastern Himalayan Region is one of the mega-biodiversity rich zones and is among the 34 biodiversity Hotspots of the world.*
  • India is among the top 3 in South Asia and top 12 destinations for biotechnology in the world, with approximately 3% share in the global Biotechnology industry. *
  • India has 2nd highest number of USFDA approved manufacturing plants outside the US.*
Reasons to Invest
  • India-UK Cancer Research Initiative has been launched in collaboration with the Cancer Research UK (CRUK). The initiative focuses on the affordability of cancer prevention and care and explores the potential to make progress against cancer consequences. Both the Department of Biotechnology and CRUK will invest (approximately) USD 6.7 Mn towards the initiative.*
  • India will be recognized as a Global Bio-manufacturing Hub by 2025 and will figure among the top 5 countries of the world.* 
  • India’s Bio-Economy is on its way to achieve 150-bn-dollar target from the current 70 bn-dollar by 2025 and will contribute effectively to the Prime Minister’s vision of a 5 tn-dollar economy by 2024-25.*
  • Pan India network Project “Genome India” has been launched for cataloguing the genetic variation in Indian population.*
  • The first Clean Energy International Incubator has been set up under Mission Innovation. The programme allows for start-ups from 23 participating European Union countries to come and incubate in India and likewise start-ups from this incubator can go to the partnering countries, thus facilitating access to global opportunities.*
  • UKRI (MRC, ESRC) and the Department of Biotechnology (DBT), India invited proposals to the UK-India Covid-19 Partnership Initiative. This initiative will provide funding for collaborative research projects with potential to deliver public health impacts in mitigating the severity of theCOVID-19 outbreak in both the UK and India.*
  • Department of Biotechnology signed MoA with CNRS France for Covid 19 vaccine.*
  • The contribution of the Indian biotechnology industry in the global biotechnology market to grow to 19% from a mere 3% in 2017 by 2025.*
  • In case of sustainable Bio-fuel, target year for 20% ethanol blending has been advanced by India from 2025 to 2023.*

 

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Key Achievements
  • Indian Centric Epidemic Preparedness (IndCEPI)- India launched a training program for "Strengthening clinical trial research capacity in neighbourhood countries". This programme will build capacity in neighbourhood countries and LMICs (Low and Middle Income Countries) for COVID-19 vaccine trails.*
  • The Indian COVID-19 Vaccine Development Mission entitled Mission "COVID Suraksha". 
  • The Centre for Bioresources and Sustainable Development has  established academic linkages with several ICAR, CSIR Institutions, for efficient implementation of programmes and create employment opportunities for the prospective young entrepreneurs of the state of Arunachal Pradesh.*
  •  The Biotech products in the country have increased from 10 in 2018 to over 700 in 2022.*
  • India's bio-economy has grown 8 times since 2014 from USD 10 bn to USD 80 bn. *
  • The number of Biotech Start-ups in the country have increased from 50 to over 5,300 in the last 10 years, because of the growing enabling ecosystem. The Government aims to increase the Biotech Start-ups arising from strong talent pool 2 times, to 10,000 plus by 2025.*
  • The Ethanol production of 3.3 Bn liters capacity has doubled to 6.5 Bn litres in 2021. *
Recent Announcements

9th September 2022: Eyestem raises USD 6.4 mn to solidify cell therapy platform and move their product of Dry AMD through early clinical trials to an international standard.

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19th July 2022: Dr Jitendra Singh also launched special Biotech Ignition Grant call for North East Region (BIG-NER) and announced financial support of up to INR 50 Lakhs each to 25 startups and entrepreneurs from North East Region to develop biotech solutions.

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7th  June 2022: Renewal of MOU between Department of Biotechnology, Ministry of Science & Technology, GOI, and Bill & Melinda Gates Foundation for Grand Challenges India partnership to accelerate research and innovation for global health needs.

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28th May 2022: Dr. Jitendra Singh inaugurates North India’s First Biotech Park at Ghatti, Kathua district, J&K.

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25th May 2022: MoU signed between Ministry of Ayush and Department of Biotechnology to facilitate Inter-Ministerial Cooperation for evidence based biotechnological interventions in Ayush sector.

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Statistics
  • India shows 12.3 % CAGR of Indian Bioeconomy.*
  • Under “Mission COVID Suraksha – The Indian COVID-19 Vaccine Development Mission” being implemented by BIRAC, a PSU of DBT, 5 proposals for candidate vaccine development, 5 proposals for capacity enhancement and 19 proposals for strengthening clinical trial sites, have been shortlisted for support.*
  • There are over 2,700 biotech start-ups and more than 2,500 biotech companies working in 2022 in the country.*
  • India’s Bioeconomy has reached over USD 80 bn in 2021 recording 14.1% growth over USD 70.2 bn in 2020.* 
  • BT Cotton, Biopesticides, Biostimulants and Biofertilizers contributed to about USD 10.48 bn in 2021 for bioeconomy of the country.*
  • India registered a sustained growth in Bioeconomy from USD 44 Bn US in 2019 to USD 80.1 Bn in 2021.*
  • 56 patents have been filed/granted in the Biotechnology Sector of India in last 3 years.*
Growth Drivers
  • The Department of Biotechnology (DBT) has been successfully coordinating with various countries and philanthropic organisation to run collaborating programs in different areas for Biotechnology. DBT signed a Programme of Cooperation (PoC) with Swedish Governmental Agency for Innovation Systems (Vinnova), Sweden. Areas of cooperation include Bio-based economy, Biomaterials, Health and life-sciences, biomedical devices, start-ups, incubators, test beds and bio-clusters.*
  • Accelerated Translational Grant for Commercialization (ATGC) has been launched to encourage technological innovation by providing funding opportunities for fundamental research that is aimed towards application development.*
  • GOI through its various agencies is supporting ninety eight (98) projects for improvement of rice (72) and wheat (26) through application of biotechnology in agriculture.*
  • The Department of Biotechnology has established Biotechnology Parks/Incubators across the country to provide infrastructure support for development of products and services. The Biotechnology parks offer facilities to scientists and Small and Medium Sized Enterprises (SMEs) for technology incubation, technology demonstration and pilot plant studies for quicker commercial development of Biotechnology. So far, the department has set up nine parks in various states:*
  1. Biotech Park, Lucknow (Uttar Pradesh)
  2. Biotechnology Incubation Centre, Hyderabad (Telangana)
  3. Tidco Centre for Life Sciences Biotech Park, Chennai (Tamil Nadu)
  4. The Golden Jubilee Biotech Park for Women, Chennai (Tamil Nadu)
  5. Biotechnology Park Technology Incubation Centre, Guwahati, Assam
  6. Biotech Incubation Centre, Cochin (Kerala)
  7. Biotechnology Park, Bangalore (Karnataka)
  8. Industrial Biotechnology Parks (IBTPs) (Jammu & Kashmir)
  9. Chhattisgarh Biotech Park, Naya Raipur (Chhattisgarh)
  • A Make in India Facilitation Cell (Biotechnology) has been established at Biotechnology Industry Research Assistance Council (BIRAC) to provide support to investors and enable the dissemination of government policies.*
  • Single National Portal for Biotech researchers and Start-Ups  "BioRRAP" is launched to cater to those seeking regulatory approval for biological research & development activity in the country and thus offer a huge relief for "Ease of Science as well as Ease of Business.*
  • MoU is signed between Ministry of Ayush and Department of Biotechnology to facilitate Inter-Ministerial Cooperation for evidence based biotechnological interventions in Ayush sector.*
  • North India’s First Biotech Park at Ghatti, Kathua district, J&K is inaugurated which will act as hub for incubation of new ideas and will support the Agri-entrepreneurs, Startups, Progressive farmers, scientists & scholars not only from J&K, but from neighboring states of Punjab, Haryana and Himachal Pradesh.*
  • The Department of Biotechnology (DBT) and the Bill & Melinda Gates Foundation have renewed the MoU, originally signed in 2012, to support innovative approaches for developing new preventions, therapies and interventions needed to solve health (human and animal), food and nutritional inequities.*
  • Special Biotech Ignition Grant call for North East Region (BIG-NER) with financial support of up to INR 50 Lakhs each to 25 startups and entrepreneurs from North East Region is announced to develop biotech solutions.*
  • BIRAC/ DBT has established a strong network of 74 specialized bio-incubation centres in 21 states/ UTs including 7 bio-incubators in the north east region – an emerging cluster. *
FDI Policy
  • 100% FDI is allowed under automatic route for Greenfield projects for pharmaceuticals.*
  • 74% FDI is permitted under the automatic route for Brownfield projects. Beyond 74% FDI, in Brownfield projects, is permitted under the Government route.*
  • 100% FDI under the automatic route is allowed for the manufacturing of medical devices.*
  • 100% FDI is allowed through the automatic route for investment in industrial parks – both new and existing.*

 

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Sector Policy

National Guidelines for Stem Cell Research 2017

The Department of Biotechnology formulates guidelines to facilitate research in the different areas of biosciences and promotes its use in the industry and utility among the people.

The National Guidelines for Stem Cell Research 2017 has been developed after taking into consideration several new scientific and technical advancements as well as the perceived challenges in the field bio-medical research.

The 2017 guidelines reiterate that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, in investigational at present. Any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine and not as a therapy.6

For more information, refer to National Guidelines for Stem Cell Research 2017.

 

Guidelines on Similar Biologics – Regulatory Requirements for Marketing Authorization in India 2016

The Guidelines on Similar Biologics prepared by Central Drugs Standard Control Organization (CDSCO) and the DBT lay down the regulatory pathway for a Similar Biologic claiming to be similar to an already authorized reference biologic.

A similar biologic product is one which is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability.

The guidelines address the regulatory pathway regarding manufacturing processes and safety, efficacy and quality aspects for similar biologics, pre-market regulatory requirements and post-market regulatory requirements for similar biologics.

For more information, refer to Guidelines on Similar Biologics 2016.

 

National Intellectual Property Rights Policy 2016

The National Intellectual Property Rights Policy 2016 (IPR Policy 2016) lays down the future roadmap for IPRs in India.

The policy aims to create and exploit synergies between all forms of intellectual property, concerned statutes and agencies.

The objectives of the IPR Policy 2016 are listed below:

  1. Create IPR awareness
  2. Stimulate generation of IPRs
  3. Develop strong and effective IPR laws, which balance the interests of rights owners with larger public interest
  4. Modernize and strengthen service oriented IPR administration
  5. Commercialize IPRs
  6. Strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements
  7. Strengthen and expand human resources, institutions and capabilities for teaching, training, research and skill building in IPRs.

For more details, please refer to National Intellectual Property Rights Policy 2016.

 

The DNA Technology (Use and Application) Regulation Bill, 2018

The bill aims to regulate the use and application of DNA technology with the aim of establishing the identities of certain categories of people, including the victims, offenders, suspects, under trials, missing persons and unknown deceased persons and provides provision for establishment of a DNA Regulatory Board (DRB).9

For more details, refer to DNA Technology (Use and Application) Regulation Bill – 2019.

 

Biosafety Research Programme

The main emphasis of the Biosafety Research Programme is to facilitate the implementation of biosafety procedures, rules and guidelines under Environment (Protection) Act 1986 and Rules 1989 to ensure safety from the use of Genetically Modified Organisms (GMOs) and products thereof in research and application to the users as well as to the environment.

For more details, refer to Biosafety Research Programme.

 

INDIA UK COVID - 19 PARTNERSHIP 

The Department of Biotechnology (DBT) and UKRI (MRC, ESRC) are pleased to invite proposals to the UK-India Covid-19 Partnership Initiative. This initiative will provide funding for R&D to deliver public health impacts in mitigating the severity of the COVID-19 outbreak in both the UK and India. 

For more details, refer to INDIA UK COVID - 19 PARTNERSHIP .

 

The Unique Methods of Management of Inherited Disorders Program (UMMID) was launched and NIDAN Kendras were set up in Government hospitals in four States for comprehensive clinical care including diagnosis, management, multidisciplinary care, counseling, prenatal testing in new born babies.*

 

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Financial Support

Union Budget 2022-23

  • The total budgetary allocation for FY 2022-23 towards the Department of Biotechnology is INR 2,581  cr.
Investment Opportunities
  • The DBT has developed bioclusters across India. These bioclusters provide the industry with the technology development and translation network that can establish India as a world-class bio-manufacturing hub.*
  • Under the Startup India initiative, the DBT is setting up a biocluster in Pune and BIRAC is supporting the development of 4 additional bio-incubators during 2018 through BioNEST scheme.*
  • Testing and standardization of medical devices: BIRAC and Kalam Institute of Health Technology (KIHT) have collaborated to facilitate start-ups, entrepreneurs, researchers, academicians, incubation centres and SMEs in the field of Testing & Standardization of Medical Devices.*
  • New investment opportunities in India are in the areas of:
    • Drug discovery and clinical trials
    • Medical devices manufacturing
    • Biosimilars
    • Secondary Agriculture.
  • INDO- SWEDEN: Indo- Sweden joint call for "Artificial intelligence for advancing healthcare across both the countries".  They have signed 26 proposals which were evaluated by a technical advisory committee.*
  • Indo-EU - The Department of Biotechnology partnered European Commission for  collaborative research about the 'Green Deal: Building a low-carbon, climate-resilient future program'. This program will generate essential knowledge of Sustainable Development Goals.*

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Foreign Investors
  • Bosch (Germany)
  • Limagrain (France)
  • Tekes (Finland)
  • Mylan (USA)
  • BPI France (France)
  • GE Healthcare (USA)
  • Abbott Laboratories (USA)
Agencies
Sources
  1. Biotechnology Assessment Report, BIRAC, https://birac.nic.in/webcontent/1574377200_Bio_Technology_Report.pdf
  2. “Ministry of Science and Technology”, Achievements of Department of Biotechnology During 2018, https://pibindia.wordpress.com/2018/12/21/achievements-of-department-of-biotechnology-during-2018/
  3. “Department of Biotechnology”, Annual Report 2018-19, http://dbtindia.gov.in/sites/default/files/Final_DBT_English_Annual_Report_2018-19.pdf
  4. “Department of Industrial Policy and Promotion”, Biotechnology Sector Achievements Report, http://www.birac.nic.in/webcontent/MII_Achievement%20Report_2017.pdf
  5. Consolidated FDI Policy, https://invest-india-revamp-static-files.s3.ap-south-1.amazonaws.com/2020-04/FDI%20Policy%202019%20revised_19%20April%202020.pdf
  6. “Indian Council of Medical Research & Department if Biotechnology”, National Guidelines for Stem Cell Research, http://dbtindia.gov.in/sites/default/files/National_Guidelines_StemCellResearch-2017.pdf
  7. “Department of Biotechnology”, Guidelines on Similar Biologics, http://dbtindia.gov.in/sites/default/files/uploadfiles/Guidelines_on_Similar_Biologics%2C2016.pdf
  8. “Ministry of Commerce and Industry”, National Intellectual Property Rights Policy, https://dipp.gov.in/sites/default/files/National_IPR_Policy_English.pdf
  9. “Department of Biotechnology”, The DNA Technology (Use and Application) Regulation Bill – 2019, http://dbtindia.gov.in/regulations-guidelines/regulations/dna-profiling-bill
  10. Union Budget speech, https://www.indiabudget.gov.in/doc/Budget_Speech.pdf
  11. “Department of Biotechnology”, Biotech Science Clusters, http://www.dbtindia.gov.in/schemes-programmes/research-facilities-resources-technology-platforms/biotech-science-clusters
  12. "Year-End Review: Department of Biotechnology", Ministry of Science and Technology,   https://pib.gov.in/PressReleasePage.aspx?PRID=1556817
  13. “Department of Biotechnology”, http://dbtindia.gov.in/sites/default/files/Unclassified%20portion%20of%20English%20Cabinet%20Summary%20for%20the%20month%20of%20September%202020.pdf
  14. Department of Biotechnology, http://dbtindia.gov.in/sites/default/files/Unclassified%20portion%20of%20English%20Cabinet%20Summary%20for%20the%20month%20of%20September%202020.pdf
  15. Department of Biotechnology, http://dbtindia.gov.in/sites/default/files/India-UK%20COVID-19%20Partnership%20Initiative.pdf
  16. “Department of Biotechnology”, Annual Report 2019-20 http://dbtindia.gov.in/sites/default/files/English%20Annual%20Report%2019-20.pdf
  17. “Department of Biotechnology”, Monthly Achievement http://dbtindia.gov.in/sites/default/files/English%20Cab%20summary_Oct20.pdf

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