The Constitutional Cognizance of Biosafety Laws in Indian Perspective
Author: Faizan Anwer
Swami Shukdevanand Law College, Shahjahanpur
The spectrum of exposition and elucidation of the constitution has been continuously widening since its inception. The emerging discipline of biotechnology leads to the emergence of biosafety laws as well as the effectiveness and efficiency of these legal remedies corresponding to its purpose and objectives. The high range of biosafety charter pertinent to emanating biosafety issues without competently and conclusively solving the prevailing challenges is a manifestation of crumbling and disintegrating ecological interactions. Ecology is thoroughly meshed up with society and therefore the disruption of socio-ecological web will eventually cause the decay of civilization. It’s high time to validate the cogency of the available legal remedies for the welfare of the ecosphere. The parallel progression and expansion of the interpretation of the constitution and the biological sciences give emergence of transforming the biosafety laws.
Key-words: Biosafety, Regulation, Laws, Constitution of India
Societies have evolved exponentially in the last few decades on almost every aspect but the evolution of science and technology has a very wide spectrum of impact on every fiber of society. [1, 2, 3, 4, 5, 6, 7] This is not astonishing that the demerits of every phenomenon are very much integrated with the merits of those phenomena. Although we make efforts to bring out the best unknowingly we make our monsters ourselves and therefore every society needs machinery to regulate, control, and coordinate, due to which the need of law and the regulatory authorities comes into the picture. In the recent past, the integration of engineering and technology with life sciences gave birth to the fields like biotechnology and bioengineering. Although the definition of biotechnology itself contains the word human welfare unknowingly it has also developed the tools that may dissociate the human welfare if not used with due care and we need to regulate them, this gives emergence for the promulgation of biosecurity and biosafety laws globally as well as at national level. The legal interpretations are also evolving over time and the spectrum of the understanding of the constitution is broadening. This has led to the amalgamation of the right to a clean environment and the right to health in Article 21 of the constitution and forms the basis to frame and develop the biosecurity and biosafety laws for the welfare of the society and to prevent the infringement of the fundamental rights of the individuals, even in the least bit.
In the words of Dr. B.R. Ambedkar, fundamental rights are the laudable gift to the individuals of the society but the question is how to make them effective. The rights are safeguarded not only by the enactment of the laws but by the social and moral conscience of the society. Adding to the view of Dr. Ambedkar, not only the social and moral conscience but also the awareness of the society is an essential element for safeguarding their rights.
The formulation and the development of biosecurity laws is necessary to fulfil the objectives of Article 21(Life and Liberty),  Article 47(Nutrition, Standard of living and Public Health),  Article 48A (Protection and improvement of Environment and Safeguarding of Forests and Wildlife), , Article 51 (Promotion of international peace and security) , Article 51A (g) (to Protect and Improve the Natural Environment including Forests, Lakes, Rivers and Wild Life, and to have Compassion for Living Creatures)  and Article 38 (Social Justice),
Article 32 was called the “Soul of the Constitution and very Heart of it” by Dr. Ambedkar. He was very right in his judgment because it gives the basis to challenge the advance and contemporary issues of the society that was yet to come. If the outcomes of the development in science and technology are suppressing the fundamental rights of any individual in any respect even in the slightest degree, he may move the Supreme Court for the provision of constitutional remedies. Similarly, under Article 226 any individual can move the High Court in a similar scenario. 
- Historical Background
Analytically, the very definition of biotechnology includes the term human welfare by employing technology to utilize the intrinsic capabilities of microbes. Let us put this question to history and get some insights.
It was during the First World War when we begin to use micro-organisms for the production of chemicals at commercial levels. Due to the British naval blockade, Germans were trying to develop the technology for the production of glycerol to manufacture explosives while the British were using fermentation technology utilizing a bacterium (Clostridium acetobutylicum). 
After the First World War, citrus crop-lands were almost completely destroyed and therefore the supply was shrinking and as a result, price was going very high. It is truly said that need is the mother of all inventions, and the alternate method of producing citric acid was developed by using another microbe (Aspergillus niger). 
- Geographical Boundaries Affecting Disparity in Research
One thing is very clear that for the development of this emerging field of study, a higher level of expertise and a large amount of funds are needed and as we all know developed countries possess a very wide spectrum of resources as well as skills and expertise and on the other hand, developing countries usually face deficit both in terms of expertise as well as the economy and this scenario creates technological gaps between the developed and developing countries and unfortunately, proper efforts for bridging these gaps are lacking. This non-uniformity of technological power among the nations of the globe may prove to be socially evil and hence it needs to be regulated at national as well as international platforms. If we fail to regulate these emerging technologies comprehensively, it may become a greater threat. [17, 18]
- The Risk of Deporting the Risk among the Nations
There is a certain level of risk that is always associated with the movement of the genetically modified organism across the boundaries of the nations and therefore the regulation of import as well as the export of GMOs is very vital in safeguarding the domestic biodiversity and the provisions of quarantine is essential to protect the flora and fauna of the nation. [19, 20, 21, 22]
In India following laws helps in regulating the international business of GMOs:
- Environment Protection Act (1986)
- The Destructive Insects and Pests Act, 1949
- Foreign Trade (Development & Regulation) Act, 1992
- Health Impacts
We are not only manipulating the genetic patterns of our foods but also architecting the genetic system of animals according to our needs. The dynamic progress of genetic engineering has made it capable of disfiguring and then restructuring and reorganizing the human genome. Undoubtedly, we have shifted from vaccines, enzymes and antibiotics to stem cell therapies making our concern for biosafety more intense. The folks of tissue culture and stem cell therapies have accepted the dangers of tumorigenicity, [23, 24, 25, 26, 27] immunogenicity, [28, 29, 30] genetic instability [31, 32, 33] and chromosomal aberrations after stem cell transplantation. Moreover, cultivation of stem cells requires animal sources for energy requirements (feeder layer) involving the risk of disease transfer from animal world to human world and that cannot be diagnosed in initial stages due to the administration of high potency suppressing drugs. [34, 35, 36] In spite of the accelerated progress, we are far away from efficient transplantation. The use of such therapies must be regulated stringently or otherwise in the name of curing the diseases we are going to invite some alien diseases. There is a very high risk of gene flow among GMOs and the wild population and this blending and homogenizing of the genetic make-up of GMOs and wild population may prove to be highly dangerous for the ecological balance. [37, 38]
- The Constitutional Interpretation of Biosafety Laws
Although there is no explicit and unequivocal annotation of biosafety in our constitution yet there is an abundance of pertinent provisions that can constitute the structure of biosafety laws are found in the constitution and provides the basis of the comprehensive regulatory framework. The two supporting pillars for the structure of biosafety laws are the Directive Principles of State Policy (Article 38, Article 47, 48A and Article 51 of Part IV of the Constitution) [14, 10, 11, 12] and the Fundamental Rights (Article 21 of Part III of the Constitution).  In our Constitution, not only the State but the citizens of the nation are also responsible under article 51A (g). 
Since the constitutional structure of biosafety laws includes the Fundamental Rights as well as Directive Principles of State Policy and therefore these laws are individualistic as well as socialistic in nature.
Biosafety laws should be clearly distinguished among the provisions that are justiciable by the court and integral to the Fundamental Rights of the countrymen and the provisions that are not justiciable by the courts and integral to The Directive Principles of The State Policy.
As per the Article-37 of the constitution , it shall be the duty of the State to apply the Directive Principles of State Policy in the promulgation of laws and therefore the priority, relevance and the significance of Article-38, Article-47, Article-48 A and Article 51 is amplified while preparing the regulatory framework for biosafety of the country and its countrymen.
The 42nd and 44th Amendments of the constitution emphasized on the socialistic goals of the Indian polity and become evident for the legislation to tend towards the socialistic parcel of the constitution in the promulgation of the statute in the future. It is the moral responsibility of the state to be concerned for the Socialistic and Economic Principles, Gandhian Principles, and the International Principles. Article 48A was inserted by the Constitution (Forty-second Amendment) Act, 1976. [40, 41]
Article-38 of DPSP emphasizes the social order that promotes the welfare of the people. “Welfare of the people” is a very wide term including public health, enhancing the nutritional standard,s and safeguarding the forest, wildlife, and the environment of the country. Biosafety laws are very much integral to all these aspects of nutrition, health, and the environment. Therefore, it is established that Article 38 provides the basis for the Socialistic Principles of DPSP .
Article-47 and Article-48 provide the basis for the Gandhian Principles of DPSPs and a tool for the fulfillment of the vision of the father of the nation, Mahatma Gandhi [10, 11].
Biosafety is not merely a national issue rather it is a global issue and India has ratified Cartagena Protocol on biosafety and today we are part of the international regulatory framework to prevent damage to its biodiversity from any probable means. Thus, Article 51 provides the basis for International Principles of Directive Principles of State Policy .
- The Federal Structure for Biosafety Laws
The Constitution of India also provides the pattern of federal design for biosafety laws. The Constitution of India since its inception has made efforts to keep the federal system more elastic. This elasticity of the federal structure of the Indian Constitution allows modifying the powers of the central and the state in different circumstances. The significance of biosecurity is vital to national security and therefore the entries of union and concurrent list exceed the state list. [42, 43, 44, 45, 46, 47, 48, 49, 50]
The disposition of federal Structure is given in the table below:
Table 1: Federal Structure of Biosafety Laws in The Constitution of India
|Entry 28||Port quarantine, including hospitals connected therewith; seamen’s and marine hospitals.|
|Entry 51||Establishment of standards of quality for goods to be exported out of India or transported from one State to another.|
|Entry 6||Public health and sanitation; hospitals and dispensaries.|
|Entry 14||Agriculture, including agricultural education and research, protection against pests and prevention of plant diseases.|
|Entry 15||Preservation, protection and improvement of stock and prevention of animal diseases; veterinary training and practice|
|Entry17B||Protection of wild animals and birds|
|Entry18||Adulteration of foodstuffs and other goods|
|Entry 29||Prevention of the extension from one State to another of infectious or contagious diseases or pests affecting men, animals or plants|
- Biosafety as Sovereign Rights
Promulgation of biosafety laws is the sovereign right of the state for the welfare of the nation and its countrymen. India as a sovereign country should promulgate the laws and make the necessary amendments in the existing legislations to achieve the goals of the Directive Principles of State Policy of the Indian Constitution.
- Regulatory Framework of Biosafety Laws in India
In India Ministry of Environment and Forests (MoEF) and The Department of Biotechnology (DBT) constituted under The Ministry of Science and Technology has been continuously contributing in the direction of the biosafety of the nation.[51, 52] Ministry of Industry, Ministry of Agriculture, Ministry of Commerce, Ministry of External Affairs, Ministry of Health and Family Welfare and Ministry of Food Processing Industry have also played a vital role in promulgating biosafety legislation. Although there are a plethora of laws in the portfolio of biosafety regulation in India yet there are many loopholes that need to be addressed. A broad basket of expertise is also needed from various fields like Molecular Biology, Plant Biology, Environment Biology, Ecology, Microbiology, Genetics, Biochemistry, Epidemiology, Pharmacology, Toxicology, and obviously the Legal Sciences. The regulatory structure of statutory bodies is given below.
Fig. 2 Regulatory Structure of Biosafety in India
The most vital among all is the Environment Protection Act, 1986 which is the outcome of the resolution of the United Nations Conference on the Human Environment held in Stockholm in June 1972. The objective of EPA is to protect and to improve the environment as well as to prevent the possible perils to human beings, other living creatures and the biosphere as a whole. Section 2 of this act defines the various pertinent terms like environment, pollutants, pollution and hazardous substances. The elucidation of the environment as per S-2 (a) opens the door to a wide variety of phenomena to be regulated under EPA. It clearly includes the interrelationship among the biotic and abiotic factors of the environment. Once we consider the interactions taking place between the various matrices of the environment like air, water, land, humans, microbes, and other living creatures, we enter into a complex nexus of nature incarnated by the flow of physical quantities like energy and mass among the diversified layers of environment that is yet to be explored to the nth degree.
The Manufacture, Use, Import, Export, and Storage of Hazardous Micro-Organisms Genetically Engineered Organisms or Cells Rules, 1989, define the terms like biotechnology, cell hybridization, gene technology, genetic engineering, and microorganisms. These rules also classified the microorganisms or genetically engineered products or cells into two major heads namely animal pathogens and plant pests and further divided into five categories (bacterial agents, fungal agents, parasitic agents, viral, rickettsial and chlamydial agents, and Special category).
The competent authorities under these rules are the Recombinant Advisory Committee (RDAC), Review Committee on Genetic Manipulation (RCGM), Institutional Biosafety Committees (IBSC), Genetic Engineering Approval Committee (GEAC), State Biosafety Coordination Committees (SBCC) and District Level Committees (DLC). All these statutory committees can be categorized as an advisory committees (RDAC), approval committees (RCGM, IBSC, and GEAC) and monitoring committees (SBCC, DLC).
The Review Committee on Genetic Manipulation includes the representatives from The Department of Biotechnology, Indian Council of Medical Research, Indian Council of Agricultural Research, Council of Scientific and Industrial Research, other experts in their individual capacity.
The District Level Committee comprises of District Collector (Chairman), Factory Inspector, and any official of the Pollution Control Board, Chief Medical Officer or District Health Officer (Convenor), District Agricultural Officer, A representative of the Public Health Engineering Department, District Microbiologists/Pathologist (technical expert), Commissioner Municipal Corporation.
There are many other laws for regulating the biosafety of the country including:
- Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998
- Revised Recombinant DNA Safety Guidelines, 1990
- Standard Operating Procedures for confined field trials, 2008
- Guidelines for the conduct of confined field trials of regulated, GE crops, 2008
- Guidelines and protocols for food and feed safety assessment of GE crops, 2008
- Guidelines for Generating Preclinical and Clinical Data for rDNA Therapeutics, 1999
- The Plants, Fruits and Seeds [Regulation of import in India Order 1989 issued under the Destructive Insects and Pests Act, 1914
- Biological Diversity Act
- National Seed Policy, 2002
- Seeds Act, 1966
- Laws pertaining to Intellectual Property Rights
- Drugs & Cosmetic Act 1940 along with Drugs and Cosmetic Rules
- Drug Policy, 2002
- EXIM Policy
- Foreign Exchange Management Act, 1999
- BRAI Bill 2013
There is a lack of synergism and uniformity among these legislations. They are redundant and overlapping in various aspects. These laws need to be revolutionized by public participation and the general masses should be made aware of what they are eating and what they are breathing. The purpose of these legislations should be to address the issues of biosecurity, biosafety, environmental risk minimization, and sustainable development rather than the evaluation of the efficacy and performance of the biotechnological products to be released in the market. The criteria and the factors adopted by the competent authorities for risk assessment should be clearly explained. We need to integrate the objectives of regulators/legislators, product developer/manufacturer, and the ultimate consumer. The structure of the regulatory framework and the focus of competent authorities should be convergent. The divergence between the ethos of the regulatory framework and the competent authorities may degrade the very purpose of the biosafety legislation. The design of biosafety legislation in India is analogous to the regulatory structure of the OECD countries. The three main aspects of these legislations are human and animal health safety, environmental and ecological conservation, and the economic consequences. However, the socio-economic aspect is heavily overlooked in these legislations giving a higher priority to the other two aspects. As a result, the representation and participation of NGOs and even the institutes like ICSSR (Indian Council for Social Science Research) have been neglected. On the other hand, the regulatory structure of the European Union (EU) is largely based on the precautionary principle. The existing legislations are not only incomprehensive but there exists a sense of antithesis among them. It’s not only about the incomprehensiveness, the proper implementation and execution is yet to be achieved. Till 2004 only three states of India have successfully composed the SBCCs and DLCs have not been set up anywhere across the country. There is a need of a balanced centralization of the regulatory system and the precise accountability of the biosafety should be fixed. Transparency is another significant issue vital for public acceptance. The minutes of meetings and the information pertinent to field trials should be put into the public domain. Competent authorities are impliedly denying the criticism from the public domain. There is a lack of punishment and penalties in case of non-compliance of the biosafety regulations. The recommendation by the Swaminathan task force to establish Agricultural Biotechnology Regulatory Authority was very striking. Although, all three task forces including the Swaminathan task force, Mashelkar task force and the Bhan task force have failed to establish public trust in the existing biosafety regulations.[55, 56]
Nicolas Gomez Davila rightly said, “Dying societies accumulate laws like dying men accumulate remedies”. There are many laws pertaining to the issue of biosafety yet we need to remove the redundancies and the overlapping authorities. A clear and well-refined regulatory framework is needed. As far as biosafety is concerned we need to rush for capacity building (Article 22 of Cartagena Protocol) to inculcate the legal and scientific or technical expertise. The scientific expertise help in developing proper methods for risk assessment and risk management while the legal expertise help in structuring and designing regulatory framework confirming the constitutional provisions. The brilliance of the legal framework depends on the expertise of both the individualistic as well as institutional or organizational level. A proper regulatory framework can be designed only after a fair risk assessment.
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