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● 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 USFDA–approved plants, after the USA.
● India adopted the product patent regime in 2005.
● Increasing government expenditure will augment the growth of the sector - the government aims to spend USD 3.7 Billion on biotechnology between 2012-17.
● India is the largest producer of recombinant Hepatitis B vaccine.
● India has the potential to become a major producer of transgenic rice and several genetically modified (GM) or engineered vegetables.
● The Indian biotech industry will grow at an average growth rate of around 30% a year and reach USD 100 Billion by 2025.
● The Indian bio-economy grew to USD 4.3 Billion at the end of 2013, up from USD 530 Million in 2003.
● The Indian biotech industry grew by 15.1% in 2012–13, increasing the market’s revenues from USD 3.31 Billion in 2011-12 to USD 3.81 Billion in 2012–13.
● The market size of the sector is expected to rise up to USD 11.6 Billion by 2017 due to a range of factors such as growing demand for healthcare services, intensive R&D activities and strong government initiatives.
● The Indian biotechnology 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 64% in total revenues in 2013, followed by bio-services (18%), bio-agri (14%), bio-industrial (3%) and bio-informatics (1%).
● Revenue from bio-pharma exports reached USD 2.2 Billion in 2013, accounting for 51% of total revenues of the biotech industry.
● 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.
● A strong pool of scientists and engineers.
● Cost-effective manufacturing capabilities.
● The setting up of national research laboratories, centres of academic excellence in biosciences, several medical colleges, educational and training institutes offering degrees and diplomas in biotechnology, bio-informatics and biological sciences.
● For global companies looking to economise, outsourcing to lower cost economies results in a cost arbitrage of more than 50%.
● Fast-developing clinical capabilities with the country becoming a popular destination for clinical trials, contract research and manufacturing activities.
● Foreign Direct Investment (FDI) up to 100% is permitted through the automatic route for greenfield and through the government route for brownfield, for pharmaceuticals.
NATIONAL GUIDELINES FOR STEM CELL RESEARCH 2O13:
● 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.
● These guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any other associated with both basic and clinical research on all types of human stem cells and their derivatives.
GUIDELINES ON SIMILAR BIOLOGICS-REGULATORY REQUIREMENTS FOR
MARKETING AUTHORIZATION IN INDIA 2O12:
● 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 authorized reference biologic.
● The guidelines address the regulatory pathway regarding the manufacturing process and quality aspects for similar biologics.
● These guidelines also address the pre-market regulatory requirements including a comparability exercise for quality, preclinical and clinical studies and post-market regulatory requirements for similar biologics.
PROVISIONS OF THE 2O14-2O15 UNION BUDGET:
● Service tax exemption for services provided by operators of common bio-medical waste treatment facilities to a clinical establishment by way of treatment or disposal of bio-medical waste or processes incidental thereto.
● Refund of customs duty paid at the time of import of scientific and technical instruments, apparatus, etc. by public funded and other research institutions, subject to submission of a certificate of registration from the Department of Scientific & Industrial Research.
● Depreciation allowance on plant and machinery has been raised to 40% from 25%.
● Customs duty exemption on goods imported in certain cases for R&D.
● Customs and excise duty exemption to recognised Scientific & Industrial Research Organisations (SIRO).
● 150% weighted tax deduction on R&D expenditure.
● A 3-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.
● Joint R&D projects are provided with special fiscal benefits.
● The setting up of a venture capital fund to support small and medium enterprises.
● Promoting innovations through BIPP, SBIRI, BIRAC and biotech parks.
● 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 Kerala, Guwahati in Assam and Chindwara in Madhya Pradesh.
● The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces.
● India constitutes around 8% of the total global generics market, by volume, indicating a huge untapped opportunity in the sector.
● Outsourcing to India is projected to spike up after the discovery and manufacture of formulations.
● Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield improvement.