The “Guidelines on Similar Biologic” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a Similar Biologic claiming to be Similar to an already authorized Reference Biologic.
India, a biotech growth catalyst
The biotechnology industry in India comprises of about 800 companies and stands amongst the top 12 biotech destinations in the world.
India has about 3% share of the global biotech industry and is home to more than 523 USFDA approved drug manufacturing facilities as on March 31, 2014. Outside the US, India has the second highest number of USFDA-approved plants after China.
Indian biotechnology industry is estimated to reach USD 11.6 bn by FY17 while growing at a CAGR of 20.3% during FY05-17. It witnessed the y.o.y. the growth of 57.1% in FY16 compared to FY15.
- By 2020, 175,000 sq. ft. of bio-incubation space has been planned and the target is to support 50 world class bio-incubators
- By 2025, Indian biotech industry is expected to reach USD 100 bn
100% FDI is allowed under the automatic route for greenfield pharma.
100% FDI is allowed under the government route for brownfield pharma in upto 74% FDI is under automatic route and beyond 74% is under government approval route.
FDI up to 100% is allowed under the automatic route for the manufacturing of medical devices.
for more details refer FDI Policy 2017
- World's largest producer of recombinant Hepatitis B vaccine
- World's largest producer of BT Cotton
- World's second highest number of USFDA approved plants
The Indian biotechnology sector is valued at USD 11 bn in 2015-16 while growing at a CAGR of 20.3% during FY05-17.
This sector is divided into five major segments- bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics. The biopharmaceutical sector accounts for the largest share of the biotech industry with a share of 64% of total revenues, followed by bio-services with an 18% market share. India is becoming a leading destination for clinical trials, contract research, and manufacturing activities, which is further fueling the growth of the bio-services sector. In FY16, bio-agri segments accounted for 14% of the biotech industry. Remaining market is catered by bio-industrial (3%) and bio-informatics (1%).
- India's Serum Institute is the largest Bio-Pharma company in the country and accounts for approximately 22% of the biopharma market.
- 30 bio-incubators and biotech parks have been supported and established from April 2014-September 2016.
- Weighted tax deduction on R&D expenditure
- Biotech industry growth (FY16, year on year)
- Bio-pharma segment revenue share (domestic)
- Professional and skilled bioinformaticians share (global)
FDI allowed in greenfield projects
FDI allowed in brownfield projects
FDI allowed in manufacturing of medical devices
July 2016 - Helix investment Holdings Pte Ltd., Singapore invested USD 12 mn in Concord Biotech Ltd
August 2015 - Tano India Pvt., Mauritius invested USD 7.4 mn in Windlas Biotech Ltd.