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 and over 300 bn dollars by 2030 from the current USD 70 bn to contribute effectively to PM’s vision of a USD 5 tn economy by 2024-25.*
  • 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. * 
  • Pan India network Project “Genome India” has been launched for cataloguing the genetic variation in Indian population. *
  • 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. *
  • India's vaccine market is expected to reach a valuation of INR 252 billion by 2025. *
  • Increasing Population and Lifestyle Changes; Share of expenditure on health in the total expenditure on social services, which has increased from 21& in FY19 to 26% in FY23 (BE). *

Explore more about infrastructure availability in Biotechnology sector >

Key Achievements
  • India's bio-economy has grown from USD 10 bn to USD 80 bn in the last 8 years. *
  • Manufacturing and marketing licenses for the commercial use of Prussian blue insoluble formulations, developed under the Technology Development Fund (TDF) scheme, have been granted to Scott-Edil Pharmacia Ltd, Baddi, Himachal Pradesh and Skanttr Lifescience LLP, Ahmedabad, Gujarat by Drugs Controller General of India (DCGI). These formulations are used for decontamination of Cesium & Thallium. It is one of the critical medicines listed by the World Health Organisation (WHO) for radiological and nuclear emergencies. *
  • Biotech Startups have grown 100 times in the last 8 years from 52 odd startups in 2014 to 5300 plus in 2022.*
  • Investment in Bio-economy increased from INR 10 Crore in 2014 to INR 4200 crore in 2022, growth of 400 times creating over 25,000 high skilled jobs.*
  • 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.*
Recent Announcements

25th April 2023: Biotech Sector in India: Tamil Nadu Government Invited to Swiss Showcase in Basel.

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10th March 2023: A novel marketplace concept set up at International Symposium on Health Technology Assessment (HTA) showcasing Health Technologies for which HTA has been done by Health Technology Assessment in India (HTAIn) strengthening 'Make in India' initiative.

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23rd February 2023: PM lauds doctors of Central Command India army for rehabilitating a young patient's skull defect using advanced 3D printing technology for titanium cranioplasty repair.

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22nd February 2023: Department of Pharmaceuticals has released the first tranche of incentives under the Pharmaceuticals PLI of INR 166 cr for 4 selected applicants.

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17th February 2023: Unique non-cytotoxic nanocomposite coatings developed to prevent post-surgical infections by ARCI, an autonomous institute of the Department of Science and Technology.

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Statistics
  • There are over 2,700 biotech start-ups and more than 2,500 biotech companies working in 2022 in the country.*
  • Biotech industry crossed one-billion-dollar R&D spend and it almost trebled within a year from 320 mn dollars in 2020 to 1.02 bn dollars in 2022.*
  • Biotech products have increased from 10 products to more than 700 in 2022.*
  • 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.*
  • 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. *
  • 74 Bio-incubation Centers created through DBT-BIRAC and 4 Industry Clusters in Kalyani, Pune, Bangalore, Delhi NCR.
  • Department of Biotechnology has funded fifty-one (51) Biotech-Kisan hubs connecting Indian farmers with best scientists and institutions out of which forty-four (44) are operational. These hubs are located in 15 agro-climatic zones of the country and are conducting activities in 169 districts.*
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

1,60,000 farmers have received benefits from the Biotech-KISAN scheme in last one year. *

 

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

National Intellectual Property Rights Policy 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 .

 

PLI scheme for Medical Devices *

The scheme was launched to establish domestic manufacturing capability of high-end medical devices under 4 target segments:

  • Cancer care/Radiotherapy medical devices - Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging devices
  • Anaesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care medical devices
  • All Implants including implantable electronic devices

The scheme has a Financial outlay of INR 3240 cr and a total of 21 applicants have been selected until 21.02.2023. An investment of 714 cr has been reported and 2900 persons have been employed under the scheme.

 

The Unique Methods of Management of Inherited Disorders Program (UMMID)

The program 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 newborn babies. *

 

 

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Financial Support

Union Budget 2023-24*

  • The total budgetary allocation for FY 2022-23 towards the Department of Biotechnology is INR 2,683.86  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.*
  • 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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Sector Reports
  1. Year End Review 2022: Department of Science & Technology
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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