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.
|Sr. no.||Sector||Number of projects||Project Amount (INR Millions)|
|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|
|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|
|14||Energy Biosciences - Biofuels||9||53.93|
|16||Genome Engineering & Technologies||43||321.16|
|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|
|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%).
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.
|(Amount in INR Million)|
|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|
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.
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
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.
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