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India, a biotech growth catalyst

India is among the top 12 destinations for biotechnology in the world, with approximately 3% share in the global biotech industry. The biotechnology industry in India, comprising about 800 companies, is estimated to have grown at a CAGR of 20.3% during 2005-17, to reach USD 11.6 bn in 2016-17.

India has the second highest number of USFDA-approved manufacturing plants outside the US. The country is currently home to more than 523 USFDA approved drug manufacturing facilities.

  •  By 2020, bio-incubation space of 175,000 sq. ft. has been planned with the target 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

HIGHLIGHTS

  • 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

Industry Scenario

The Indian biotechnology sector that was valued at USD 11 bn in 2015-16, is estimated to have expanded at a CAGR of 20.3% during 2005-17.

The 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 18% market share. India is becoming a leading destination for clinical trials, contract research and manufacturing activities, which is further fuelling the growth of the bio-services sector. Bio-agri segments accounted for 14% of the biotech industry in 2015-16, while the 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.
  •  Thirty bio-incubators and biotech parks have been supported and established during April 2014-September 2016.

Growth Drivers

gDB
  • Weighted tax deduction on R&D expenditure

    150%

  • Biotech industry growth (FY16, y.o.y.)

    57.1%

  • Bio-pharma segment revenue share (domestic)

    64%

  • Professional and skilled bioinformaticians share (global)

    10%

Key policies

Biotechnology Industry Research Assistance Council (BIRAC)

BIRAC is a not-for-profit public sector enterprise, set up by Department of Biotechnology (DBT), Government of India. The council acts as an interface agency to strengthen and empower the emerging biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.

Key strategies underlying BIRAC are as follows:

  1. Foster innovation and entrepreneurship
  2. Promote affordable innovation in key social sectors
  3. Empowerment of start-ups and small and medium enterprises
  4. Contribute through partners for capability enhancement and diffusion of innovation
  5. Enable commercialization of discovery
  6. Ensure global competitiveness of Indian enterprises
BIRAC support for startups

BIRAC supports startups through the following:

  1. BIRAC Supported Incubators- Bio-incubation allows harnessing of the entrepreneurial potential of start-ups by providing access to infrastructure as well as mentoring and networking platforms that the start-ups could use during their fledgling days.
  2. Biotechnology Ignition Grant Scheme (BIG)- This is a grant funding scheme available to scientist entrepreneurs from research institutes, academia and startups.
  3. BIRAC University Innovation Cluster (UIC)- Under UIC, five university clusters have been identified to establish Cluster Innovation Centres.
  4. Social Innovation Programme for Products: Affordable and Relevant to Societal Health (SPARSH)- The programme initiated by BIRAC under the aegis of Department of Biotechnology, Ministry of Science & Technology, aims at promoting the development of innovative solutions to society’s most pressing social problems.
  5. Early Translational Accelerator (ETA)- BIRAC helps bridge gap between basic research and product needs initiatives that help translate early discoveries made in a basic research setting into potentially valuable validated technologies.
Bioenergy Roadmap Vision 2020

The vision is to create biotechnology enterprise equipped with viable green and clean technologies for achieving bioenergy security. Vision document outlays what our long term goals should be if we are to truly achieve cost effective clean energy development with recent refinements to the technology.

National policy on Similar biologics 2016

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.

National Biotechnology Development Strategy 2015-2020

The Department of Biotechnology (DBT) announced the National Biotechnology Development Strategy in September 2007. Through the strategy, biotechnology was recognized as a sunrise sector that needed focussed attention. The cornerstone of the strategy was to focus on building coherence and connectivity between disciplines and bring together variegated skills across sectors to enhance synergy.

National Guidelines for Stem Cell Research

These Guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives. These guidelines do not apply to research using non-human stem cells or tissues. Further, they do not regulate the use of hematopoietic stem cells for treatment of various haematological, immunological and metabolic disorders which has already been established as a standard of medical care.

Open Access Policy 2015

In order to achieve the aforementioned objectives, each institution is encouraged to set up its own inter- operable institutional open access repository (IR) for its research papers and review articles published in peer-reviewed journals. The Ministry of Science and Technology has set up a central harvester (www.sciencecentral.in) that will harvest the full text and metadata of these publications. This central harvester will have a link to each institutional repository.

State government policies (BIRAC)

BIRAC is a new industry-academia interface and implements its mandate through a wide range of impact initiatives, be it providing access to risk capital through targeted funding, technology transfer, IP management and handholding schemes that help bring innovation excellence to the biotech firms and make them globally competitive. In its three years of existence, BIRAC has initiated several schemes, networks and platforms that help to bridge the existing gaps in the industry-academia Innovation research and facilitate novel, high quality affordable products development through cutting edge technologies. BIRAC has initiated partnerships with several national and global partners to collaborate and deliver the salient features of its mandate.

State government policies (BIRAC) could be accessed from the given link.

FDI Facts

  • FDI allowed in greenfield projects 

  • FDI allowed in brownfield projects

  • FDI allowed in manufacturing of medical devices

Recent Investments

  • 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.

Major Investors