Biotechnology Law

Biotechnology refers to a diverse set of traditional and new technologies that use biological systems, living organisms or derivatives to produce products or processes for a specific use. The Biotech Industry in India is witnessing accelerated growth due to new enterprise and innovation.

India’s biotech sector has attracted significant amount of attention over the past two decades. Several global companies have aggressively joined hands with Indian companies due to India’s strong generic biotechnology potential. The Government of India has taken several initiatives to improve the biotechnology sector in the country as well as offer enough scope for research in this field. The prime initiatives taken by the government includes the following: A Network of Technology Centres and promotion of start-ups by Small Industries Development Bank of India (SIDBI) are among the steps taken by the Government of India to promote innovation and entrepreneurship in the agro industry proposed by the Ministry of Micro, Small & Medium Enterprises (MSME) in a new scheme. The Department of Biotechnology (DBT) along with other government funded institutions such as National Biotechnology Board (NBTB) and many other autonomous bodies representing the biotechnology sector, are working together in order to project India as a global hub for biotech research and business excellence. With the country offering numerous comparative advantages in terms of R&D facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player.

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.

India is a most favoured nation for the multinational to invest. 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. 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. India has bundance of highly-skilled and trained pool of talent. Special purpose organisation such as Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology is there to support the industry through funding, mentoring, hand-holding and infrastructure support. In this sector, Foreign Direct Investment (FDI) up to 100% is permitted through the automatic route for Greenfield and through the government route for brownfield, for pharmaceuticals. 

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.

Renowned foreigner investors are as follows: Bill and Melinda Gates Foundation; Wellcome Trust; BPI France; USAID; World Health Organisation; Grand Challenges Canada; Tekes, Finland; Limagrain (France); Endo Pharmaceuticals (USA); Mylan Inc. (USA); Sanofi Aventis (France); Abbot Laboratories (USA); Fresenius (Singapore); and Hospira (USA).

On Ease of doing business front the government of India has launched a Unified online portal (Shram Suvidha) for: Registration of Labour Identification Number (LIN); Submission of returns; Grievance redressal; Combined returns under 8 labour laws; Online portals for Employees State Insurance Corporation (ESIC) and Employees Provident Fund Organization (EPFO) for- Real-time registration, Payments through 56 accredited banks, Online application process for environmental and forest clearances, 14 government services delivered via eBiz, a single-window online portal, Investor Facilitation Cell established, Dedicated Japan+ Cell established, Consent to Establish/NOC no longer required for new electricity connections, Documents reduced from 7 to 3 for exports and imports, Option to obtain company name and DIN at the time of incorporation; Simplified forms for- Industrial Licence, Industrial Entrepreneurs Memorandum, Many defence sector dual-use products no longer require licences, Validity of security clearance from Ministry of Home Affairs extended to 3 years, Extended validity for implementing industrial licences,No distinction between partial and full commencement of production for all products, Colour-coded maps for locations requiring NOC from the Airports Authority of India hosted online

Proposal is also in the pipeline to  Eliminate requirement of minimum paid-up capital and common seal; Integrate processes for obtaining PAN, TAN, ESIC and EPFO registration with incorporation of company; and Single-window clearance for import and export. 

Prime Agencies: Department of Biotechnology [DBT], Ministry of Science & Technology, Government of India; Department of Science and Technology, Ministry of Science and Technology,Government of India; Biotechnology Industry Research Assistance Council; Council of Scientific and Industrial Research; Association of Biotechnology Led Enterprises; Confederation of Indian Industry [CII]; Federation of Indian Chambers of Commerce and Industry [FICCI].

The Department of Biotechnology (DBT) is an Indian government department, under the Ministry of Science and Technologyresponsible for administrating development and commercialisation in the field of modern biology and biotechnology in India. Patenting of innovations, technology transfer to industries and close interaction with them have given a new direction to biotechnology research in India. Initiatives have been taken to promote transgenic research in plants with emphasis on pest and disease resistance, nutritional quality, silk-worm genome analysis etc. On the other hand, molecular biology of human genetic disorders, brain research, plant genome research, development, validation and commercialisation of diagnostic kits and vaccines for communicable diseases, food biotechnology, biodiversity conservation and bioprospecting, setting up of micropropagation parks and biotechnology based development for SC/ST, rural areas, women and for different States. Organisation’s mandate and the centres of excellence that it has set up to achieve this goal are listed below. DBT has a clear mandate to the following tasks: Promote large scale use of Biotechnology; Support R&D and manufacturing in Biopharmaceutical Industry; Responsibility for Autonomous Institutions; Promote University and Industry Interaction; Identify and Set up Centres of Excellence for R&D; Integrated Programme for Human Resource Development; To serve as Nodal Point for specific International Collaborations; Establishment of Infrastructure Facilities to support R&D and production; Evolve Bio Safety Guidelines, manufacture and application of cell based vaccines; Serve as nodal point for the collection and dissemination of information relating to biotechnology.

Autonomous Institutes: Centre for DNA Fingerprinting & Diagnostics, Hyderabad; National Institute of Animal Biotechnology, Hyderabad; National Centre for Cell Science, Pune; National Brain Research Centre, Manesar; Rajiv Gandhi Centre for Biotechnology, Thiruvanantpuram; Institute of Bioresources and Sustainable Development Imphal; National Institute of Immunology Delhi; Institute of Plant Genome Research Delhi; Institute of Life Sciences, Bhubaneswar; National Agri-Food Biotechnology Institute, Mohali.

Public Sector Undertakings: Bharat Immunologicals and Biologicals Corporation Limited, Bulandshahar; Indian Vaccine Corporation Limited Delhi, Biotech Consortium India Limited, New Delhi

There are many renowned institutions in the field of biotechnology: IITs-Kanpur, Roorkee and Guwahati; NIT Warnagal; NSIT Delhi; Thapar University; Manipal Institute of Technology, Karnataka; Vellore Institute of Technology (VIT); and Sir M. Visvesvaraya Institute of Technology.

Policy Agencies: Department Of Biotechnology; Biotechnology Industry Research Assistance Council (BIRAC); Indian Council Of Medical Research; Council Of Scientific And Industrial Research; Indian Council Of Agricultural Research; National Biodiversity Authority;

Regulatory Agencies: Review Committee On Genetic Manipulation; Genetic Engineering Approval Committee; Recombinant DNA Advisory Committee; Institutional Biosafety Committee; State Biotechnology Coordination Committees; District Level Committees

Concerned Ministries: Ministry Of Science & Technology & Earth Sciences; Ministry of Micro, Small & Medium Enterprises (MSME).

We at, Hello Counsel, have extensive experience in biotechnology sector. Our Firm advises clients on statutory and regulatory requirements. We have assisted our clients in preparing technical research papers, obtaining necessary licences and regulatory and statutory approvals, provided consultancy services and legal opinions on issues related to biotechnology sector.

Our legal team provides assistance to our clients in patent and trademark portfolio strategy, creation and management, Intellectual property litigation, patent infringement and oppositions, Intellectual property opinions including validity, infringement, and peer review opinions, due diligence for financials, mergers & acquisitions, technology-driven agreements including in-depth knowledge of cross-border licensing, collaborations, R&D partnerships and consultation.

Legislations Governing Biotechnology Laws

• Biological Diversity Act, 2002.

Biotechnology Laws Judgments

• Aruna Rodrigues Versus Union of India, Writ Petition (Civil) No. 260/2005, Judgment Dated: 10/05/2012, Bench: S.H. Kapadia, C.J.: A.K. Patnaik, J.: Swatanter Kumar, J., Supreme Court Of India- Citation: 2012(4) SCR 553: 2012(5) SCC 331: 2012(5) JT 319: 2012(5) SCALE 262: 2012(3) Supreme 644: 2012(4) SLT 45- Environmental Law- Constitution of India- Article 32- Public interest litigation- Regarding bio-safety concerns- Appointment of expert committee, direction for- Release of Genetically Modified Organisms (GMOs) in the environment without examining the biosafety concerns- Challenged- Imposition of an absolute ban sought for in release of GMOs- Appointment of Expert Committee to advise on the issue- Parties were ad idem on the constitution of expert committee and terms of reference as suggested in the ministry’s meeting dt. 15.3.2011- Directions issued for constitution of Expert Committee- Consent order passed (Para 6).

• Centre for Environment Law, WWF-I Versus Union of India, Writ Petition (Civil) No. 337/1995, Judgment Dated: 15.04.2013, Bench: K.S. Radhakrishnan, J.: Chandramauli Kumar Prasad, J., Supreme Court Of India, Citation: 2013(8) SCC 234: 2013(7) JT 450: 2013(5) SCALE 710: 2013(5) SLT 697.- Environmental Law- Environment- Convention biology, What is?- Held, Convention biology is the science that studies bio-diversity and the dynamics of extinction (Para 51)- HELD: No specie can survive on the brink of extinction indefinitely and the probabilities associated with a critically endangered specie make their extinction a matter of time. Convention biology is the science that studies bio-diversity and the dynamics of extinction. Eco-system approach to protecting endangered species emphasises on recovery, and complement and support eco-system based conservation approach. Reintroduction of an animal or plant into the habitat from where it has become extinct is also known as ex-situ conservation (Para 51).

• Ishaan Research Lab [Commissioner of Central Excise v. Ishaan Research Lab (P) Ltd.]- Civil Appeal No. 7357-7372/2001, Judgment: 08/09/2008, Bench: Ashok Bhan, J. & V.S. Sirpurkar, J., Supreme Court Of India, Citation: 2008(13) SCR 208: 2008(13) SCC 349: 2008(10) JT 1: 2008(12) SCALE 270: 2008(230) ELT 7- Environmental Law- Excise and Customs- Ayurvedic medicines- Scope- Products `Bio- Heena‘ and `Bio Heena leaf’ may not be called as Ayurvedic Medicine- Assessee rightly gave up his claim of classification of theses products under Chapter 30 and more precisely under Entry 3003.30- Central Excise Tariff- Items 3003.30, 3304 & 3305.

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