Biotechnology Laws and Regulations in India

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Biotechnology can be defined as the technological applications of biological processes. It consists of living organisms or their body parts to form a new product or a process that can improve the environment as well as the quality of life. Various applications of biotechnology are implemented in agriculture, medicine, energy, industry, and or environment sectors.

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Biotech laws in India

The Indian biotechnology sector has observed a strident increase in R&D and its application in numerous sectors like agriculture, medicine, industries, and the environment.


Being a rich biodiversity country, biotechnology in India provides excessive opportunities by using the bioresources for the social and economic growth of its individuals. Renewable resources encouraged advanced products and services to upsurge the production efficacy of numerous industrial procedures in a supportable way.


The Indian agriculture sector is repeatedly facing the great challenge to meet the request of India’s exponential populace growth with dropping per-capita cropland. In this situation biotechnology has revealed the probable to swing over this challenge while safeguarding the livelihood security of the country’s huge farming population.


The development of biotechnology is a fruitful and successful industry challenge associated with research and development, creation of investment capital, technology transfer, and technology absorption, patentability and intellectual property, affordability in pricing, regulatory issues, and public self-assurance.


National Biotechnology Policy of India

For the agricultural biotechnology sector, India has established a policy and a regulation system in the 1980s. Currently, the country is witnessing severe changes in all biotechnology sectors.


Execution of the Rules for the Manufacture, Usage, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989 under the Environment Protection Act, 1986 (EPA) was the very first enactment credited to agrarian biotechnology in India.


The EPA (1986) and the Rules (1989) are still seen to control the pending parliamentary sanction of the Biotech Regulatory Authority of India (BRAI), India’s Biotech Policy, and governing mechanisms. The growth of India’s Biotech Policy can be characterized in three phases:


  1. a) Policy and regulatory establishment from 1989−2002 when Bt cotton was permitted for commercialization;
  2. b) Policy developments from 2003−2010 when the Ministry of Environment and Forest (MoEF) levied a moratorium on Bt brinjal; and
  3. c) Policy discussions from 2010, in which Bt brinjal and BRAI are under moratorium.

India’s biotechnology governance is comparatively independent, but, is administered by the three ministries- Ministry of Science and Technology, Ministry of Environment, Forest and Climate Change, and Ministry of Agriculture.

Proposed Biotechnology Regulatory Authority of India (BRAI)

A complicated policy containing various ministries of the central administration regulates the existing biotechnology policy in India. The existing policy does not maintain a strong supporting legal bottleneck other than the Rules for the Manufacture, Usage, Import, Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989.


In this system, the BRAI is recommended to facilitate the careful practice of contemporary biotechnology and similarly to boost the effectiveness and efficiency of biotechnological law on examination, transport, import, manufacture, and usage of organisms and commodities of biotechnology.


The outline of the BRAI bill was announced in 2008, and then its requirements and processes were under endless discussion. Many have tagged the BRAI as unconstitutional as it would interfere with the farming division involving GM crops, which is under a state government’s counsel.


Another disagreement with the BRAI is that it requires people’s participation as it would not affect any representative from the civil community while most of the recommended administrators are bureaucrats.


The formulated BRAI is intended to redefine the administration policy of the Indian biotechnology realm. A three-tier governance policy is recommended to be steered by a leading governance unit containing one chairperson, two full-time members, two part-time members, and two advisory groups The other two categories would be the inter-ministerial Governing Board of ~10 representatives and the Biotechnology Advisory Council of ≤15 representatives.


Issues and Challenges

High level of risk

Numerous Biotech companies are granted patents for their products that are manufactured by them so that they can recover all the expenses that they have spent in the procedure of Research & Development. When the patent expires, the products have more popularity in the market as related to their competitors.


The main problem which arises here is that the investors have to consider a factor that this period leads to a huge risk due to late results through Research & Development.


Level of Affordability

Another big problem encountered by biotech enterprises is the degree of affordability and rate of expenses. Many drugs need a huge scale of amount and also numerous firms do not trust the R&D methods used by these industries to make a proper product for the benefit of the populace at large.


Problem of Privacy

Another issue which we face in this industry is the issue of privacy. Many data are taken by the competing industry and henceforth they use it in their product to increase huge profits in the markets. This is also a huge challenge for the industries and therefore they must protect it very firmly.



A Well-known norm of a habitation with high quality of vitality of the population of a country is the primary outcome of technological inventions. It proposes substantial recourses for both the industrialized as well as the developing countries to deal with social and economic difficulties like poverty assistance, job production, food safety, etc. With difference to some other nations, India is running a so-called ‘democratic’ strategy for its biotechnology leadership.


The Indian biotechnology system and the DBT (regulatory agency) are introducing the BRAI code to stabilize and authorize biotechnology regulatory incentives. Various elements of the biotechnology law presently cover numerous acts and agents, many of which will require to be revised to solidify and employ the BRAI.


The recent regulation would possess requirements for the development of biotechnology, rising alliance with the state administrations, and would necessarily facilitate public enthusiasm in the regulatory process. This would eventually promote international business and trade as well.

Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements. Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.

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