Biotechnology

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SUMMARY
  • The Biotechnology industry in India is divided in the following segments – Biopharmaceuticals, Bio-services, Bio-agriculture, Bio-Industrials and Bio-IT.1
  • India is currently among the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region.2
  • The Indian biotech industry comprises of approximately 800 companies and is home to the second highest number of United States Food & Drug Administration (USFDA) approved plants.3
REASONS TO INVEST
  • The Government of India is taking steps to make the Biotechnology Industry worth $100 Bn by 2025.4
  • India has been following the Product Patent Regime since 2005.5
  • 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) $6.7 Mn towards the initiative.6
  • 15 new skill development courses for Post Graduate Certificate/Diploma have been implemented with the objective of providing high-quality, hands-on training in tools and techniques in Medical Biotechnology, Agricultural Biotechnology and Computational Biology.7
  • 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.8
  • Special purpose organisation such as Biotechnology Industry Research Assistance Council (BIRAC), a Public-Sector Undertaking of Department of Biotechnology, have been set up to support the industry through funding, mentoring, handholding and infrastructure support.
STATISTICS
  • India’s biotech industry holds 2% of the global market share.9
  • In the year 2018-19, Department of Biotechnology (DBT) published 1,194 publications. A total of 99 patent applications were filed and 15 patents were granted.10
  • The DBT has developed 83 new processes/products/technologies in the year 2018-19.11
  • BIRAC has developed 5 new bio-incubators during 2018 through BioNEST scheme adding an additional high-end incubation space taking the total space to 391,849 sq. ft.12
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.13
  • To promote the Startup India initiative, the DBT, along with BIRAC has launched various schemes and programmes. Through the BioNEST scheme, BIRAC is supporting 4 new Bio-incubators during 2018.14
  • 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.15
  • 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)

For further details, please log onto Biotech Parks & Incubators.

  • 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.16
FDI POLICY
  • 100% FDI is allowed under automatic route for Greenfield projects for pharmaceuticals.17
  • 74% FDI is permitted under the automatic route for Brownfield projects. Beyond 74% FDI, in Brownfield projects, is permitted under the Government route.18
  • 100% FDI under the automatic route is allowed for the manufacturing of medical devices. 19
  • 100% FDI is allowed through the automatic route for investment in industrial parks – both new and existing.20
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.21

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.22

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

 

National Biotechnology Development Strategy 2015-2020:

The cornerstone of the National Biotechnology Development Strategy 2015-2020 (NBDS 2015-2020) is to focus on building coherence and connectivity between disciplines and bring together variegated skills across sectors to boost synergy.

10 guiding principles have been determined to drive the strategy.23

  1. Building a skilled workforce and leadership
  2. Revitalizing the knowledge environment at par with the growing bio-economy
  3. Enhance research opportunities in basic, disciplinary and inter-disciplinary sciences
  4. Encourage use-inspired discovery research
  5. Focus on biotechnology tools for inclusive development
  6. Commercialization of technology-nurturing innovation, translation capacity and entrepreneurship
  7. Ensuring a transparent, efficient and globally leading regulatory system and communication strategy
  8. Fostering global and national alliances
  9. Strengthen institutional capacity and redesigned governance models
  10. Create a matrix of measurement of processes as well as outcome

For more details, refer to National Biotechnology Development Strategy 2015-2020.

 

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:24

  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).25

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.
FINANCIAL SUPPORT

Key Highlights of Budget 2019-20

  • An allocation of $369.1 Mn has been made towards the Department of Biotechnology, under the Ministry of Science and Technology.26
  • The budget allocation towards Biotechnology Research and Development stands at $211 Mn.27
  • The budget allocation towards the Biotechnology Industry Research Assistance Council stands at $4.4 Mn.28
INVESTMENT OPPORTUNITIES
  • Various Indian States, such as Andhra Pradesh, Gujarat, Rajasthan and Telangana release their own Biotechnology policies to promote investment in Biotechnology in their State. For example, Telangana launched the Life Sciences Policy (2015-2020) with the aim of making Telangana the most preferred destination for life science activities, and attract new investments worth $2.89 Bn in the industry by 2020.29
  • 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.30 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.31
  • 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.32
  • Hybrid seeds, including GM (Genetically Modified) seeds, represents new business opportunities in India based on yield improvement.
  • BIRAC has launched an Equity based fund - AcE (Accelerating Entrepreneurs) Fund. An equity fund to address to accelerate the growth of entrepreneurs in the field of biotechnology by lending funding support of up to - USD 150,000 for promising ventures.
  • New investment opportunities in India are in the areas of:
    • Drug discovery and clinical trials
    • Medical devices manufacturing
    • Biosimilars
    • Secondary Agriculture.
FOREIGN INVESTORS
  • Bosch (Germany)
  • Limagrain (France)
  • Tekes (Finland)
  • Mylan (USA)
  • BPI France (France)
  • GE Healthcare (USA)
  • Abbott Laboratories (USA)
AGENCIES
KEY ACHIEVEMENTS
  • A diagnostic test for Tuberculosis meningitis with nearly 100% sensitivity and about 91% specificity has been developed by All India Institute of Medical Sciences (AIIMS) and Translational Health Science and Technology Institute (THSTI), Faridabad.33
  • “Dementia Science Programme: Incidence/Prevalence/Risk/Intervention analysis of dementia and basic research thereof” has been launched in India with the aim of providing reliable data regarding incidence, prevalence, biomarkers and risk and protective factors associated with the pathology of dementia.34
  • New Wheat variety Unnat PBW343 has been developed by Punjab Agricultural University, Ludhiana. The new variant of wheat is resistant to leaf rust and stripe rust. The PBW343 has an average plant height of 100 cm, matures in around 155 days and has an average grain yield of 23.2 quintals per acre.35
  • Two bacterial blight resistant Basmati Rice varieties, Pusa Basmati 1728 and Pusa Basmati 1718 have been developed by Central Variety Release Committee after testing. These two new variants replace Pusa Basmati 1401 and Pusa Basmati 1121.36
  • 15 new skill development courses for Post Graduate Certificate/Diploma were implemented with an objective to provide high-quality, hands-on training in tools and techniques in Medical Biotechnology, Agricultural Biotechnology and Computational Biology.37
SOURCES
  1. “BIRAC”, Make in India for BIO-TECH the way forward, http://birac.nic.in/mii/uploaded/MII-Report.pdf, accessed on 03 June 2019
  2. “CII Pharma”, History/Introduction, http://ciipharma.in/history-introduction.php, accessed on 03 June 2019
  3. “CII Pharma”, History/Introduction, http://ciipharma.in/history-introduction.php, accessed on 03 June 2019
  4. “BIRAC”, Make in India for BIO-TECH the way forward, http://birac.nic.in/mii/uploaded/MII-Report.pdf, accessed on 03 June 2019
  5. “Patents”, History of Indian Patent System, http://www.ipindia.nic.in/history-of-indian-patent-system.htm, accessed on 03 June 2019
  6. “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/, accessed on 03 June 2019
  7. “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/, accessed on 03 June 2019
  8. “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/, accessed on 03 June 2019
  9. “Biotechnology Industrial Research Assistance Council,”¸Biotechnology Sector Achivements Report, http://www.birac.nic.in/webcontent/MII_Achievement%20Report_2017.pdf, accessed on 03 June 2019
  10. “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/, accessed on 03 June 2019
  11. “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/, accessed on 03 June 2019
  12. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  13. “Department of Biotechnology”, Annual Report 2018-19, http://dbtindia.gov.in/sites/default/files/Final_DBT_English_Annual_Report_2018-19.pdf, accessed on 03 June 2019
  14. “Department of Biotechnology”, Annual Report 2018-19, http://dbtindia.gov.in/sites/default/files/Final_DBT_English_Annual_Report_2018-19.pdf, accessed on 03 June 2019
  15. “Department of Biotechnology”, Annual Report 2018-19, http://dbtindia.gov.in/sites/default/files/Final_DBT_English_Annual_Report_2018-19.pdf, accessed on 03 June 2019
  16. “Department of Industrial Policy and Promotion”, Biotechnology Sector Achievements Report, http://www.birac.nic.in/webcontent/MII_Achievement%20Report_2017.pdf, accessed on 03 June 2019
  17. Department for Promotion of Industry and Internal Trade, Consolidated FDI Policy, https://dipp.gov.in/sites/default/files/CFPC_2017_FINAL_RELEASED_28.8.17.pdf, accessed on 03 June 2019
  18. Department for Promotion of Industry and Internal Trade, Consolidated FDI Policy, https://dipp.gov.in/sites/default/files/CFPC_2017_FINAL_RELEASED_28.8.17.pdf, accessed on 03 June 2019
  19. Department for Promotion of Industry and Internal Trade, Consolidated FDI Policy, https://dipp.gov.in/sites/default/files/CFPC_2017_FINAL_RELEASED_28.8.17.pdf, accessed on 03 June 2019
  20. Department for Promotion of Industry and Internal Trade, Consolidated FDI Policy, https://dipp.gov.in/sites/default/files/CFPC_2017_FINAL_RELEASED_28.8.17.pdf, accessed on 03 June 2019
  21. “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, accessed on 03 June 2019
  22. “Department of Biotechnology”, Guidelines on Similar Biologics, http://dbtindia.gov.in/sites/default/files/uploadfiles/Guidelines_on_Similar_Biologics%2C2016.pdf, accessed on 03 June 2019
  23. “Department of Biotechnology”, National Biotechnology Development Strategy 2015-2020, http://dbtindia.gov.in/sites/default/files/DBT_Book-_29-december_2015.pdf, accessed on 03 June 2019
  24. “Ministry of Commerce and Industry”, National Intellectual Property Rights Policy, https://dipp.gov.in/sites/default/files/National_IPR_Policy_English.pdf, accessed on 03 June 2019
  25. “Department of Biotechnology”, The DNA Technology (Use and Application) Regulation Bill – 2019, http://dbtindia.gov.in/regulations-guidelines/regulations/dna-profiling-bill, accessed on 03 June 2019
  26. “India Budget”, Ministry of Science and Technology, Department of Biotechnology, https://www.indiabudget.gov.in/doc/eb/sbe87.pdf, accessed on 04 September 2019
  27. “India Budget”, Ministry of Science and Technology, Department of Biotechnology, https://www.indiabudget.gov.in/doc/eb/sbe87.pdf, accessed on 03 September 2019
  28. “India Budget”, Ministry of Science and Technology, Department of Biotechnology, https://www.indiabudget.gov.in/doc/eb/sbe87.pdf, accessed on 03 September 2019
  29. “Department of Industrial Policy and Promotion”, Biotechnology Sector Achievements Report, http://www.birac.nic.in/webcontent/MII_Achievement%20Report_2017.pdf, accessed on 03 June 2019
  30. “Department of Biotechnology”, Biotech Science Clusters, http://www.dbtindia.gov.in/schemes-programmes/research-facilities-resources-technology-platforms/biotech-science-clusters, accessed on 03 June 2019
  31. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  32. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  33. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  34. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  35. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  36. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
  37. “Ministry of Science and Technology”, Year End Review: Department of Biotechnology, http://pib.nic.in/newsite/PrintRelease.aspx?relid=186662, accessed on 03 June 2019
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