- 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.
- 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.
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.
- These guidelines apply to all stakeholders including individual researchers, organisations, 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 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
- 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
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:
- Providing impetus to utilizing the knowledge and tools to the advantage of Humanity
- 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
- Creating India as a world class Bio-manufacturing Hub
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.
PROVISIONS OF THE 2016-2017 UNION BUDGET:
- The turnover limit to avail the Presumptive Tax Scheme under section 44 AD, has been increased from USD 153846.2 to USD 307692.3. The taxpayers carrying a business will be allowed to avail this scheme for which they will have to declare profits at minimum 8% of the total turnover and they will be exempted from the requirement of maintaining any books of accounts
- New manufacturing companies incorporated on or after 1.3.2016 to be given an option to be taxed at 25% + surcharge and cess provided on fulfilment of certain conditions
- Lower corporate income tax has been proposed for the next financial year of relatively small enterprises
- 100% deduction of profits for 3 out of 5 years for startups setup during April, 2016 to March, 2019. MAT will apply in such cases
- 10% rate of tax on income from worldwide exploitation of patents developed and registered in India by a resident
- Custom single window project have been announced and would be implemented at major ports and airports from the beginning of next financial year
· Exemption from the service tax on services provided by BIRAC approved biotechnology incubators to incubatees with effect from 1.4.2016
· Service tax services of assessing bodies empaneled centrally by Directorate General of training, ministry of Skill Development & Entrepreneurship Development w.e.f. 1.4.2016
· Refund of customs duty paid at the time of import of scientific and technical instruments, apparats, etc. by public funded and other research institutions, subject to submission of certificate of registration from the department of scientific and industrial research
· 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
· 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 Biotechnology Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Research Assistance Council (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 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
- Drug discovery and clinical trails
- Medical devices manufacturing
- Secondary agriculture
- 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.