New Delhi: Recently Prime Minister Mr Narendra Modi unveiled the “Make in India” campaign, with an aim to turn the country into a global manufacturing hub. Biotechnology Sector is one of the sectors which has identified by government among 25 sectors that will be covered under the Make In India plan. The Make in India campaign aims at turning the country into a global manufacturing hub by smoothening business processes and attracting foreign companies to set up factories in India and invest in the country’s infrastructure.
According to a Special Report prepared by the Association of Biotechnology-Led Enterprises (ABLE), the India’s fast-growing BioEconomy has crossed the $35.1 billion in 2015. The report was released on the inaugural day of the BIO International Conference at Moscone Convention Center in San Francisco on June 7. The Indian biotechnology sector is divided into five major segments; bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics. The biopharmaceutical sector accounts for the largest share of the biotech industry with a share of 64% in total revenues in 2015, followed by bio-services (18%), bioagri (14%), bio-industrial (3%) and bio-informatics (1%).
The sector has in the past seen high growth with a CAGR in excess of 20 percent and the key drivers for growth in the biotech sector are increasing investments, outsourcing activities, exports and the government’s focus on the sector. 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. The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces.
Apart from pharmaceutical sectors, biotechnology innovations and research are instrumental in related healthcare systems, agricultural industry, polymers and materials sectors. Research and development in this area is relatively time consuming and involves huge investment with risk involved with the outcome. To promote such results much more importance is affixed with respect to patenting the inventions in said field, and enabling the growing research sector to monetarily sustain itself.
‘Make in India’ campaign in biotechnology sector
As per the report published in Make in India initiative; Indian biotech industry will grow at an average growth rate of around 30 percent a year and reach USD 100 Billion by 2025. 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.
Budget provisions for the sector include the service tax exemption for services provided by operators of common biomedical 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 and Industrial Research.
A look at the incentives
- 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 recognized Scientific &and 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
- Import Duty Exemption : Promotion of Import Duties on key R&D, contract manufacturing / clinical trial equipment and duty credit
- Priority Sector Lending: Enable lending by Indian banks to biotech companies as priority sector lending.
- Customs Duty Removal: Remove customs duty on raw materials imported into India, that go into making the finished product is imported duty free.
- Simplification of Procedures: Simplification and streamlining of procedures for import, clearance and storage of biological, land acquisition, obtaining environmental and pollution control approvals would be simplified and streamlined within shorter time frame lines through consultations with various central and state government departments.
- Fostering Inter-Company Relationships: The Indian Government further intends to make efforts to remove hurdles for contract research especially for input output norms and tax on revenue generated through contract research / R&D.
- Developing Communication Systems: One significant feature of the biotech industry is the fluidity and variety of its inter-company relationships, traditionally much greater than in other industries.
- 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.
Few key initiatives
Draft guidelines on examination of biotech applications
The Indian Patent Office (IPO) has issued draft guidelines on examination of biotechnology patent applications. The guidelines detail illustrative examples on various facets of patentability of biotechnology related inventions, including novelty, inventive step, industrial application, sufficiency of disclosure, clarity of claims and biodiversity related issues.
The patentability of biotechnology related inventions particularly genetic engineering has also been discussed. The details of wording of claims, clarity, support and sufficiency of the disclosure are provided. However, for better understanding of the issues related to novelty and inventive step, a preliminary discussion of claims of biotechnology related inventions are covered. These include the polynucleotides or gene sequences, polypeptides or protein sequences, vectors, gene libraries, host cells, micro-organisms and stem cells plants and animals tissue culture, pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides and antibodies or antigen binding fragments thereof monoclonal or polyclonal.
Biotechnology Patent Facilitation Cell (BPFC)
In order to help the patent seekers, a Biotechnology Patent Facilitation Cell (BPFC) has been catering to the need of promotion of biotech research by creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area. Apart from that, it is also providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis. It has also been entrusted to keep a watch on development in the area of IPR and make important issues known to policy makers, bio-scientists, biotech industry, etc.
Guidelines on Transfer and Intellectual Property Rights
The Ministry of Science and Technology has issued the guidelines “Instructions for Technology Transfer and Intellectual Property Rights”, which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research etc. The salient features include ownership of intellectual property, transfer of technology, royalty to inventors, norms for private industry, patent facilitating fund and mandatory dissemination of nformation by the institutions.
Guidelines for Stem Cell Research 2O13 in place now:
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.
Revised ‘India specific’ biosimilar guidelines announced
The Indian government has announced a revised set of guidelines for manufacturing and marketing of similar biologics in the country to help Indian companies tap a large size of a potential $290 billion global market for biosimilars. While the global centric ‘Biosimilar Guidelines’ adopted in 2012 have been well appreciated, there was an overall sentiment for few amendments and additions to meet the requirements of Indian industry
The guidelines outlined a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years. “These will help increase access to some of the key medicines for Indian patients and also create a dynamic manufacturing industry of similar biologics in India,” said India’s Minister for Health and Family Welfare, Dr J P Nadda in a video message to the ongoing BIO International Convention in San Francisco on June 8, 2016.
The Association of Biotechnology-Led Enterprises (ABLE) team led by its Chairperson Dr Kiran Mazumdar-Shaw has been working closely with the regulators over the past year to formulate the new biosimilars guidelines. Two final meetings in May 2016 drafted most of the new guidelines
With several biologics off the rack of patent shelves in the next five years, the combined sales potential of more than US$ 60 billion represents a massive opportunity for India to contribute through vaccines and biosimilars.