Biotechnology: Promising a Better & Sustainable Future for India

Empowering & Engineering India’s Agriculture and Health Sector with Genetics

The Biotechnology Industry in India has shown an exponential growth over the past ten years, raising over 6 times its original amount. Recent positive trends such as the growing demand for healthcare services, increased demand for food and nutrition intensive R&D activities, and strong government initiatives are expected to help the industry reach a booming $11.6 billion in 2017. 

Sunil Kumar Gupta, renowned business expert, economist, author and philanthropist, predicts that the continuous investment in R&D could potentially lead to India becoming a global biotech hub in the coming years. With convincing facts and  figures, he proposes that aspects such as GM crops and vaccines, if brought into the limelight, could help Indian companies become future world leaders. 

The Present Scenario: 

The Biotechnology sector is one of the sunrise sectors in India. The government is investing substantially for creating human capital and infrastructure with a special focus on R&D to develop India into a world class bio manufacturing hub. The sector in India, which is currently growing at 20% is expected to go up to USD 11.6 Billion by 2017. The focus is on making the Indian biotechnology sector reach USD 100 billion by 2025. Currently, India’s biotech industry holds 2% of the global market share and is the third largest in the Asia-Pacific region.

Facts & Figures:

 India is among the top 12 biotech destinations in the world and ranks third in the Asia Pacific.

 India has the second highest number of United States Food & Drug Administration (USFDA) approved plants.

 No.1 producer of Hepatitis B vaccine recombinant.

 Indian biotech industry shall touch USD 100 billion by 2025.

 Large consumer base with increasing disposable income.

 The Indian biotech industry is expected to grow at 30.46 percent CAGR to reach USD 100 billion by 2025.

 The Biotechnology Industry in India has grown from $1.1 billion in 2005 to $7 billion in 2015 and is expected to reach $11.6 billion in 2017.

 The Indian biotech sector is divided into five major segments- bio-pharma, bio- services, bio-agri, bio-industrial and bio-informatics.

 The bio-pharmaceutical sector accounts for the largest share of the biotech industry with a share of 62% of total revenues in 2015, followed by bio-services (18%), bio-agri (15%), bio-industrial (4%) and bio-informatics (1%).

 Supported 104 new startups, 346 companies, 509 projects including 115 collaborative projects through BIRAC, a Public Sector Unit of Government of India.

 100 Intellectual Property facilitated.

 175,000 sq. ft. of bioincubation space created and the target to support 50 world class bioincubators by 2020.

 5 University Innovation Clusters created and 1 regional innovation center.

Sector Policy:

National Guidelines for Stem Cell Research 2013:

 The guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.

Guidelines on Similar Biologics-Regulatory Requirements for Marketing Authorization in India 2012:

 The Guidelines on Similar Biologics prepared by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a biologic claiming to be similar to an already authorised reference biologic

National Biotechnology Development Strategy 2015:

 The National Biotechnology Development Strategy 2015-2020 was launched on December 30, 2015. The Strategy intends to establish India as a world class bio manufacturing hub by:

 Launching a major well directed mission backed with significant investment for generation of new Biotech Products

 Establishing a strong Infrastructure for R&D and Commercialization 

National Intellectual Property Rights Policy 2016 (IPR Policy 2016)

 India's National IPR policy was released in May 2016 with an aim to:

 Generate awareness of IP (Intellectual Property) in the country

 To push IPRs as a marketable financial assets which will promote innovation and entrepreneurship in the country 

Reason to Invest:

 India is amongst the top 12 biotech destinations in the world and ranks third in the Asia Pacific region.

 India has the second highest number of U.S. Food and Drug Administration (USFDA)-approved plants, after the USA.

 India has adopted the product patent regime in 2005.

 India is the world's leading supplier of affordable vaccines and producer of recombinant Hepatitis B vaccine.

 India is the fastest growing major economies with GDP growth rate of above 7%.

 India has the potential to become a major producer of transgenic rice and several genetically modified (GM) or engineered vegetables.

 Special purpose organisation such as Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of

Biotechnology, to support industry through funding, mentoring, handholding and infrastructure support.

 

Growth Drivers:

 The sector has seen high growth with a CAGR in excess of 20% and the key drivers for growth in the biotech sector are increasing investments, outsourcing activities, exports and the government's focus on the sector. 

 Accelerated clearances for Green/Brownfield Projects.

 The setting up of national research laboratories, centers of academic excellence in biosciences, several medical college, educational and training institutes offering degrees and diplomas in biotechnology, bio-informatics and biological sciences.

 Fast developing clinical capabilities with the country becoming a popular destination for clinical trials, contract research and manufacturing activities.

 

Financial Support:

 Depreciation allowance on plant and machinery has been raised to 40% from 25%

 Customs duty exemption on goods imported in certain cases R&D

 Customs and excise duty exemption to recognised Scientific & Industrial Research Organisation (SIRO).

 150% weighted tax deduction on R&D expenditure 

 A three-year excise duty waiver on patented products

 100% rebate on own R&D expenditure

 125% rebate if research is contracted in publicly-funded R&D institutions

 The setting up of a venture capital fund to support small and medium enterprises

 Promoting innovations through Biotechnology Industry Partnership Programme(BIPP), Small Business Innovation Research Initiative(SBIRI), Biotechnology Industry Research Assistance Council(BIRAC) and biotech parks

FDI Policy

 100% Foreign Direct Investment (FDI) is allowed under the automatic route for greenfield pharma.

 100% Foreign Direct Investment (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.

Investment Opportunities:

 The Department of Biotechnology has established biotech parks in various parts of the country to facilitate product development, research and innovation, and the development of biotechnology industrial clusters

 Operational biotech parks are located at Lucknow in Uttar Pradesh, Bangalore in Karnataka, Kalamassery and Kochi in Kerela, Guwahati in Assam and Chindwara in Madhya Pradesh

 Biotech Industrial clusters are located in Bangalore (Bangalore Lifesciences cluster and Bangalore Bioinnovation Centre), NCR Faridabad, Pune, Hyderabad and Chennai (Medtech)

 The parks offer investors incubator facilities, pilot plants facilities for solvent extraction and laboratory and office spaces

 BIRAC has funded 15 incubation centers offering a whole host of instrumentation facilities and services

 India constitutes around 8% of the total global generics market, by volume indicating a huge untapped opportunity in the sector

 Hybrid seeds, including GM (Genetically Modified) seeds, represents new business opportunities in India based on yield improvement

 New Investment opportunities in India are in the areas of

1. Drug discovery and clinical trails

2. Medical devices manufacturing

3. Biosimilars

 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 a funding support of up to – USD 150,000 for promising ventures.

Agencies:

 Department of Biotechnology, Ministry of Science & Technology, Government of India (www.dbtindia.nic.in)

 Department of Science and Technology, Ministry of Science and Technology, Government of India (www.dst.gov.in)

 Biotechnology Industry Research Assistance Council (www.birac.nic.in)

 Council of Scientific and Industrial Research (www.csir.res.in)

 Association of Biotechnology Led Enterprises (www.ableindia.in)

 Confederation of Indian Industry (www.cii.in)

 Federation of Indian Chambers of Commerce and Industry (www.ficci.in)

 

The Biotechnology industry has immense growth potential, multiple opportunities and a wide

ranging variety of perks. Sunil Kumar Gupta has further elaborated on these very dimensions,

by giving information on the best opportunities in India, in his book “Make in India.” You can

find out more by reading his engaging and informative blogs, or checking out his website

www.sunilkumargupta.com.

 

 

 

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