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- 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.
- The ‘National IPR policy’ announced by the Government of India in May 2016 while helping promote innovation, R&D and entrepreneurship, also lays down processes to expedite IPR filings, which is critical for the success of this sector.
Policy Initiatives & Investments
- 100% FDI is allowedunder automatic route for Greenfield projects for pharmaceuticals; for Brownfield projects, 74% FDI is permitted under the automatic route.
- For manufacturing of medical devices, the sector was opened for 100% FDI under the automatic route on January 21, 2015.
- To attract investments in Industrial parks, 100% FDI is allowed through automatic route to new and existing industrial parks.
Government has introduced several tax incentives in the budget 2016-17 to promote the sector.
- The turnover limit to avail the Presumptive Tax Scheme under section 44 AD has been increased to INR 2 crore from INR 1 crore.
- New manufacturing companies incorporated on or after March 1, 2016 to be given an option to be taxed at 25% + surcharge and cess on fulfillment of certain conditions.
- The new Biosimilar Policy known as the Guidelines on Similar Biologics announced by the Central Drugs Standard Control Organization (CDSCO) in March 2016 addresses the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects.
- The guidelines advocates for post-marketing studies within 2 years of receiving marketing permission/ manufacturing license. It also provides information on when a confirmatory clinical safety and efficacy study can be waived.
Support for Startups
- The Government aims to scale-up the number of start-ups in biotechnology sector to 2,000 over next three years.
- 5 new bio-clusters, 50 new Bio-incubators, 150 technology transfer offices and 20 Bio-connect offices are being set up in research institutes and universities across India.
Ease of Doing Business initiatives
Government has taken several initiative under ease of doing business to promote the sector.
- Norms for import and export of human biological samples have been relaxed; nolicense required to import or export biological samples w.e.f August 4, 2016.
- A ‘Make in India’ Facilitation Cell (Biotechnology) at BIRAC has been established for handholding investors and to enable dissemination of Government policies.