Biotechnology

SUMMARY

• 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.

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 up to 74% FDI is under automatic route and beyond 74% is under the government approval route.
• FDI up to 100% is allowed under the automatic route for the manufacturing of medical devices.

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.
• 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 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 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

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 biomanufacturing 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 the 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 marketable financial assets which will promote innovation and entrepreneurship in the country.

FINANCIAL SUPPORT

PROVISIONS OF THE 2016-2017 UNION BUDGET:

Tax Incentives

• The turnover limit to avail of 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 of this scheme for which they will have to declare profits at a minimum of 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 fulfillment 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 set up from 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 has been announced and would be implemented at major ports and airports from the beginning of the next financial year

Service Tax

· 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

Other Incentives:

· 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 the submission of a 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 recognized 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 the Biotechnology Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Research Assistance Council (BIRAC), and biotech parks.

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
  4. 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 funding support of up to - USD 150,000 for promising ventures.