Biotechnology


 

OVERVIEW

Biotechnology plays a pivotal role in the scientific innovation ecosystem of the country. India has grown exponentially in the field of Science and Technology in the last four years and has addressed many problems in the society, through research and development. India is the 3rd largest biotech destination in the Asia Pacific Region and among top 12 biotech destinations in the world. India accounts for approximately 3% in the global biotechnology industry. According to Biotechnology Industry Research Assistance Council (BIRAC) Annual Report 2017-18, India’s Biotech industry is valued at US$ 44.47 billion and is growing at a rate of 6.8%. The sector is distilled into five major segments- Bio-pharma, Bio-services, Bio-agri, Bio-industrial, and Bio-informatics. Bio-pharma segment dominates the industry with 54.67% share in the total Bioeconomy through diagnostics and medical devices, followed by Bio-agri which constitutes 23.17% of the total share. Vaccines contributed 30% of Bio Pharma, while therapeutics contributed for the rest.

Capacity and Production

India’s Biotech industry is the largest producer of recombinant Hepatitis B vaccine and BT Cotton in the World. With the second highest number of US Food & Drug Administration (USFDA)-approved manufacturing plants outside the US, India homes more than 523 USFDA approved drug manufacturing facilities.

The Indian biotech innovation ecosystem witnessed 183 patent applications during 2014-18. During the same period, 301 technologies and products were developed and commercialized. With the support of more than 2500 institutions and 8200 scientists, the Department of Biotechnology (DBT), under the Ministry of Science and Technology, Government of India, published more than 10,500 publications in these four years. It also supported 650 start-ups and entrepreneurs during the same period.

Sector-wise projects Sanctioned by DBT during 2018-19
Sr. no. Sector Number of projects Project Amount (INR Millions)
1 Agriculture Biotechnology 21 179.08
2 Animal Biotechnology(Including Animal Diagnostic & Vaccine) 13 173.76
3 Aquaculture And Marine Biotechnology 15 73.73
4 Basic plant Biology, Agriculture and Frontier Area 19 104.09
5 Basic Research In Modern Biology 29 238.34
6 Biocare 22 96.94
7 Biomedical Engineering (Medical Devices, Diagnostics and Implants) 4 27.65
8 Bio-resources and Secondary Agriculture 4 18.55
9 Biotech Based Programmes For Women 5 15.42
10 Biotech Based Programmes For Rural Development 22 119.01
11 Biotech Based Programmes For SC/ST 7 34.68
12 Biotech-KISAN 13 154.36
13 Forest Biotechnology 22 157.80
14 Energy Biosciences - Biofuels 9 53.93
15 Environmental Biotechnology 9 124.50
16 Genome Engineering & Technologies 43 321.16
17 Infrastructure Facilities 7 2109.18
18 Medical Biotechnology - Human Developmental & Disease Biology (HDDB) 1 5.80
19 Medical Biotechnology - Human Genetics And Genome 21 187.31
20 Medical Biotechnology - Infectious Diseases 26 207.83
21 Medical Biotechnology - Non-Infectious Diseases 25 245.43
22 Medical Biotechnology - Stem Cell Biology 6 28.16
23 Medical Biotechnology- Neuroscience 14 96.39
24 Medical Biotechnology-Vaccine Research And Diagnostics 8 709.35
25 Nanoscience And Nanotechnology Application In Biology 45 433.95
26 North Eastern Region (NER BPMC) 127 1230.50
27 Public Health Food And Nutrition 15 154.75
28 Technology Development in Silk and its application in biomaterials 3 96.83
29 Theoretical and Computational Biology 12 166.63
30 Translational Research on Medicinal and Aromatic Plants products 5 112.39
GRAND TOTAL 572 7688.37
Source: DBT, Ministry of Science & Technology

The DBT sanctioned a total of 572 projects worth INR 7688.37 million in 2018-19. Out of the total value, Infrastructure facility projects acquired a major share of 27.4%, followed by projects in North Eastern Region (16%).

Exports

According to CRISIL Research, India's biopharmaceutical exports recorded a CAGR of 11% during the period 2012-13 and 2017-18. Further, revenue of the biopharmaceuticals industry grew at 15% on-year in 2017-18, led by the growth in the therapeutic segment. Although, competition persisted in the pentavalent vaccines segment, strong demand supported the growth in 2017-18.

Export of Selected Commodities under Biotech Industry
(Amount in INR Million)
Commodity 2017-18 2018-19
Vaccines for human medicine 41574.87 37171.90
Vaccines for veterinary medicine 566.46 593.10
Animal Vegetable Fertilizers, when mixed together or chemically treated; fertilizers 808.09 634.39
Other enzymes prepared enzymes 3208.54 2337.23
Composite Diagnostic/lab Reagents 2965.58 2978.80
Other articles for the conveyance/packing of goods 7102.48 7914.50
Source: DGCIS

FDI

Foreign Direct Investment (FDI) of 100% is allowed under the automatic route for Greenfield pharma. Out of 100% FDI allowed for brownfield pharma, up to 74% is under the automatic route while for beyond 74%, government approval route is in place. Additionally, FDI up to 100% is allowed under the automatic route for the manufacturing of medical devices.

Outlook

Growth in Bio-Pharma sector is aided by demand for recombinant vaccines and therapeutics, especially in semi-regulated markets. Indian companies are amongst the largest suppliers of vaccines to the World Health Organisation (WHO) and other such programmes, supported by demand from Asia, Latin America, East Europe and Africa.

Demand from UNICEF (United Nations Children's Fund) and PAHO (Pan American Health Organisation) is expected to support volume growth of players. On the other hand, the launch of bio similars in the regulated markets over the next five years is expected to help drive incremental growth in the exports segment and offset impact of pricing pressure in the vaccines segment. The low-cost advantage for Indian vaccines (30-40% lower than in the US and Europe) is estimated to be another growth driver. Additionally, availability of low-cost skilled labour and lower material and equipment costs give India an edge.

According to CRISIL Research, during FY 2018- 2023, growth in biopharma is expected to be higher on account of new product launches in the domestic market, coupled with approvals and launches in the regulated market.


 

SELECT GOVERNMENT INCENTIVES

Select Government Incentives

  • Under Biotechnology Industry Research Assistance Council’s, (BIRAC) BioNEST programme, 30 bio incubation facilities have been established across the country. In 2017-18, BIRAC launched Product Commercialization Unit (PCU) which helps start-ups to facilitate the process of product commercialization and de-risk the challenges faced by them. To take care the financial needs of the startups/entrepreneurs, BIRAC has been acting as an instrument in connecting its beneficiaries with venture capitalists, biotech/healthcare accelerators and early stage funders.
  • During 2018-19, 15 new Biotechnology Incubators and 15-20 new Technology Business Incubators were established to incubate start-ups in India. BIRAC alone supported 3000 additional start-ups. MANAK (Million Minds Augmenting National Aspiration and Knowledge) is another new initiative by DBT to broaden the base of innovation pyramid to produce future entrepreneurs in large numbers.
  • Indo-US collaboration on Genome Engineering/ Editing was launched in order to provide opportunities to brightest Indian students and scientists to gain exposure and access to world class research facilities in leading U.S. institutions through student’s internship, overseas fellowship and visiting professorship programmes.
  • SAEN (Secondary Agriculture Entrepreneurial Network) was launched in 2018 with an aim to promote new enterprises and to support existing industry in the secondary agriculture sector.
  • A major Mission program on Antimicrobial Resistance (AMR) was launched in October, 2018 with the vision to develop indigenous and cost-effective therapies against AMR; categorization of AMR-specific pathogen priority list of India; establishment of Bio-repository for AMR-specific pathogens; and development of rapid and cost-effective diagnostic kits to identify AMR-specific pathogens.
  • Accelerated Translational Grant for Commercialization (ATGC) was launched to encourage technological innovation by providing funding opportunities for fundamental research that is explicitly aimed towards application development.
  • Cattle Genomics programme was launched to improve the germplasm of Indian Cattle breeds. The aim of this programme is to identify elite animal at an early stage and also to reduce the cost and time interval of breeding programme in future.
  • "Bharat Boston Bioscience Beginning -B 4, Phase II" for two years was launched with a provision for 16 postdoctoral students to undergo training in Harvard University.
  • DBT-PGGF “Plant Genotyping and Genomics Facility” (PGGF) anchored at NIPGR, New Delhi in PPP mode was established. This national facility is a single-window service system for advanced genomics technology services that could positively influence the Indian Seed industry. The facility is expected to have the potential to evolve into a leading edge genotyping service provider and a consulting facility that would have impact not only on agriculture in India, but could serve as a model on a global basis.
  • A Program on Bovine Tuberculosis (bTB) was launched in collaboration with the Bill and Melinda Gates Foundation, focusing on bTB surveillance for bTB prevalence, bTB control program through BCG vaccination, establishment of repository, and training of young scientists.
  • To cater to aspirational districts programme of Government of India, DBT has launched a new programme on “Rural Bioresource complex”. In the first phase, 9 proposal institutions were awarded funding, to address some of the pertinent issues related to health and nutrition, agriculture & allied areas using biotechnological tools, techniques and processes for bringing these aspirational districts in the mainstream.

 

SELECT EXPORT MARKET REGULATIONS

Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies.

For more Information: https://www.usda.gov/topics/biotechnology/how-federal-government-regulates-biotech-plants

The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in safe conditions.

For more information: https://ec.europa.eu/food/plant/gmo/legislation_en