Biotechnology from its very advent in India, has resulted in a misfortune. The pay-out trilogy of BT Cotton, BT Brinjal and Protato has traumatised the Indian agrarian society. Even after the incident of countless farmer suicide and Environmental hazard, India is investing a huge amount of its economy in Biotechnology. India lacks in a major regulatory framework which includes scattered authority resulting in a balkanized regime of Biotechnology oversight and limited expertise of agencies. These flaws raised many ethical and legal questions. The advent of this new method of meddling of technology with the natural processes of life is a situation of principal concern. In the paper researchers will put forward these ethical and legal implications of Biotechnology.
Keywords: Bacillus Thuringiensis (BT Cotton), BT Brinjal, Biotechnology, Environment Ethics.
Introduction
India has been devoting special attention to biotechnology and its applications from over past two decades. In spite of all the efforts, the risk-factor this new technology possesses is undeniable. Indian biotechnology industry is witnessing a boom which is expected to grow at 30.46 percent Compound Annual Growth Rate (CAGR) to reach USD 100 billion by 2025.[i] It has grown from $1.1 billion in 2005 to $7 billion in 2015. Up to 2025, it is expected to touch $100 billion as per the National Biotechnology Development Strategy 2015-2020.[ii] In this sector, the biopharmaceutical sector accounts for the major share of 62% of total revenues in 2015.[iii] Other sectors include bio services, bio-agriculture, bio-industrial and bioinformatics which accounts for the share of 18 percent, 15 percent, 4 percent and 1 percent respectively.[iv]
In simple words, biotechnology can be introduced as the exploitation of biological processes for agricultural, industrial and other purposes. It includes the genetic manipulation of microorganisms for developing hormones, antibiotics, pesticides, etc.[v] This methodology is used to attain desired characteristics from a particular gene such as a plant that is resistant to a specific pest or disease, which further gives a boost to crop production.[vi]
But everything good comes up with a cost, so does this rapidly developing biotechnology. There is a wide-ranging debate regarding the usage of this technology in India after dreadful past encounters by Indian agronomists. The pay-out trilogy of BT Brinjal, BT Cotton (GMOs) and genetically modified potato has resulted in frequent farmer suicides[vii], barrenness of fertile lands[viii], Environmental hazards[ix] and adverse health effects to animals and humans.[x] The probing reason for this massacre was the ineffective implementation of laws. Hence, Biotechnology Regulatory Authority of India Bill (BRAI Bill) 2013 was proposed to be enacted for the regulation of modern biotechnology in the country by the Ministry for Science and Technology (MOST).[xi] This effort failed because BRAI bill fell short to meet the international standards which put this sector into darkness. There is no convincing legislation to deal with this issue till date.[xii] In the international scenario, the Nagoya Protocol came into existence in 2014 to regulate this mechanism.[xiii] Despite India becoming a signatory to this protocol, it is still debatable whether Indian agrarian society is ready to move on from conventional agricultural methods to the ostensible modern methods of GMOs and LMOs.
Therefore, the researchers will try to discuss the existing regulations and their failure to achieve the desired objectives. Furthermore, the researchers will discuss the reasons for the failure of BRAI bill. The researchers will conclude the paper stating how the use of biotechnology in India without any definite legislation could possibly cross the line demarcated between the fair use of environment and violation of the environmental ethics.
The Future of man and mankind is threatened, radically threatened, in spite of very noble intentions, by men of science … their discoveries have been and continue to be exploited – to the prejudice of ethical imperatives – to ends of destruction and death to a degree never before attained, causing unimaginable ravages … This can be verified as well in the realm of genetic manipulations and biological experiments as well as in those of chemical, bacteriological or nuclear armaments.[xiv]
-Pope John Paul II, in an address to UNESCO
Laws dealing with biotechnology: Multiple yet Ineffective
The regulations of the biotechnology started in 1982 when the National Biotechnology Board (NBB) was established.[xv] It proposed certain safety guidelines for the undertaking of biotech research in laboratories. In 1986 the NBB was transformed into the Department of Biotechnology (DBT) under the Ministry of Science and MOST. It made various efforts to promote the usage of indigenously applicable biotechnologies in the country by forming safety guidelines.[xvi] This responsibility was relocated to Ministry of Environment & Forests (MoEF) in 1961 under the Government of India (Allocation of Business) Rules 1961 after apprehending the importance of adequately assessing biosafety, biodiversity and environmental risks.[xvii] Subsequently, MOEF started to regulate the GMOs and products prescribed under the existing Environmental Protection Act 1986 (EPA 1986), which was enacted by the Parliament of India in 1986.
In 1989 Parliament of India drafted and notified ‘the rules for the manufacture, use, import, export, and storage of hazardous microorganisms, genetically engineered organisms or cells’[xviii] which was referred as the EPA Rules 1989. The rules considered GM crops, GMOs, and the genetic engineering products as ‘inherently harmful’ alike hazardous substances that cause harm to human beings, living creatures, property or the environment.[xix] These Rules outlined the competent authorities into three-tier system and arrangement of such authorities for management of numerous facets of GMOs which includes-
- Policy Advisory Committee which includes Recombinant DNA Advisory Committee (RDAC).
- Regulating and Approval Committees which includes Institutional Biosafety Committee (IBSC), the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC).
- Post-Monitoring Committee’ which includes State Biotechnology Coordination Committee (SBCC) and the District Level Committee (DLC).[xx]
These committees have to coordinate with the DBT, under the MOST. It has allotted the biosafety, risk assessment and risk management related aspects of GM crops under EPA Rules 1989 and is considered to be the main governmental body for assessing the development of biotechnology.[xxi]
Apart from these committees, the regulation of GM crops is managed by three legislative acts passed by the Parliament of India and administered by different ministries. These comprise of the Seed Act 1966 & the Seeds (Control) Order by Ministry of Agriculture (MOA), EPA 1986 implemented by MOEF and the Food Safety and Standard Act 2006 (subsumed the Prevention of Food Adulteration Act 1954) by the Ministry of Health and Family Welfare (MOH&FW)[xxii] under which the Food Safety and Standards Authority of India (FSSAI) was introduced as a regulatory authority.
But all these measures failed in their implementation due to which parliament of India introduced BRAI bill in 2013 which researchers have discussed in later part of the paper. And will proceed with the lacunas due to which above mentioned regulations failed.
All the efforts put in by the government failed drastically which led the Indian biotechnology sector in a big loop of uncertainties. The Indian regulatory system was not only complex but also besets with bureaucratic hold-ups. It delayed the whole process of securing government assent. In Indian system, there is a case to case testing of biosafety. The biotechnology related product woos the regulatory attention at the primary level of the genetic event.[xxiii] And there were multiple layers of regulation which caused the approval process to take three and five years, and sometimes even more than ten years.[xxiv] The foremost problem was the lack of effective coordination among these regulations which caused ignorance of innovations taking place in the biotech space.[xxv] Consequently, there were divided roles and responsibilities which were diverse in their application and lacked in an assimilated, synchronized action within a holistic, well-tailored ecosystem. The evidence of which were proposed in the 2012 report of the Committee on Agriculture headed by Basudeb Acharia.[xxvi] It was observed that the role of GEAC has not been defined appropriately and there were enough questions on its autonomy as an approval-granting body.[xxvii] Similarly, the committee observed that both the GEAC and RCGM seemed to have underdeveloped organizational structures.[xxviii]
Similar was the case with FSSAI. There was the inadequacy of infrastructure in lab or surveillance. There was also very narrow research support on food science and risk assessment.[xxix] And FSSAI did not enact any specific laws concerning this matter and GEAC was handling all the functions of FSSAI.[xxx] Even though it came up with an interim regulatory framework which proposed to set up GM foods and safety assessment unit[xxxi] in it but there was no implementation for the same. The FSSAI had also been accused of selectively arranging particular regulatory issues while overlooking other significant ones.[xxxii]
In addition to these factors, there was another barrier for a partial understanding of biotechnology by the society which caused a quarrelsome political atmosphere in India that is often unsupportive of the biotech industry.[xxxiii] The political leaders and civic activists favor themselves by creating a state of paranoia among people regarding biotechnology which subsequently made authorities afraid to take any regulatory initiative.[xxxiv] This made them to even refuse the testing of other GM crops. This was evident in the case of BT eggplant where a moratorium was announced by MoEFCC even after GEAC recommended commercial cultivation.[xxxv] The reasons mentioned was the risk on the safety of Humans and environment. But after seven years, the status of BT eggplant still stands where it was left in 2010 and there is no clear securing approval by GEAC till now.[xxxvi]
All these failures of implementation of law gave Indian society a horrible memory to live with. The worst sufferers were the agrarian society as they witnessed a traumatized situation of debt, poverty, hunger, and death.
Dreadful Reminiscences of the Past: The pay-out trilogy of bt brinjal, bt cotton and protato
The traumatic past witnessed by the Indian farmers makes it irrefutable that acceptance of biotechnology is a double-edged sword. In this process, the worst affected could be the small farmers. What if the costs of obtaining this biotechnology are too high or the reaction of the innovation is too low?
In this case, the possible situation would be the overpowering of small farms by the dominant industrial counterparts speedy adaptation and consumption of biotechnology innovations.[xxxvii]
Another point of disagreement of biotechnology by the farmers is the delegation of control of the new industry. Presently, the research on biotechnology is wholly in the hands of private corporations, National Centres or educational institutes, with small farmers left out of the development process. Thus it would not be wrong to say that there is no active representation of small farmers interests at the primary research level in agricultural biotechnology.[xxxviii]
1. The Bacillus Thuringiensis (BT Cotton) case
GEAC on 26th March 2002 gave its conditional approval to Monsanto and Mahyco for commercial planting of the genetically constructed Bt Cotton in India.[xxxix]They promised the farmers that this new genetically modified BT Cotton will increase the production which will result in more sustainability and empowerment. Enticed by these guarantees and seeing a prosperous future of more production and fewer insecticides, farmers borrowed money and purchased these crops, by paying thousand times more then what they would have paid for traditional crops. As a result, 95% of the market was owned by BT Cotton producers.[xl] Nonetheless, this step turned out into a nightmare because this BT cotton was desired to resist main pest i.e. bollworm, but they generated high tolerance towards secondary pests such as Whiteflies which forced the farmers to use more insecticides. It was a serious case of adopting an unethical methodology for the commercialization of biotechnology because these insecticides were provided by the same companies who were providing BT cotton seeds. [xli]
In India, 3 lakh farmers committed suicide in the past 20 years. And it is not at all surprising to say that majority of them were cotton farmers, the reason is the financial crisis aggravated by BT Cotton.[xlii] The reason is that GM crops make soil less fertile because they transfer their genes to soil bacteria and fungi. Subsequently, these bacteria and fungi start behaving abnormally in a way that their function of breaking down organic material reduces due to which soil become progressively less fertile. In case farmer wants to switch to the conventional methodology of crop production they have to take at least a whole season to regenerate the soil. Therefore, BT cotton field trials were a sham. The research on this subject was not held by scientific norms and in spite of this GEAC gave its approval.
The experiment conducted shows that BT cotton is not suitable for Indian conditions. If the same amount of attention had gone to the traditional methods and sustainable farming systems then India would be able to develop a unique model of farming where the land is not polluted and where farmers are not forced to commit suicide. GM crop experiments demonstrate that India is moving towards an era of biological pollution which will be more destructive and harmful to the environment and human health.[xliii]
2. The Potato Incident
On 2nd January 2003, a plan for “protato” was introduced by G. Padmanaban, the director of India’s prestigious Indian Institute of Science in collaboration with Monsanto. This gave birth to the genetically modified potato which became a part of an anti-hunger strategy. This genetically modified/engineered potato increases the deficiency of iron and calcium in children under the age group of 13 and when provided to the already malnourished children it caused more harmful effects and greater deficiencies.[xliv]
After this incident, Indian activists believed that there was no need for such technology. As it was not adequately tested and can cause a devastating effect in the near future.
3. The Bt Brinjal case
GEAC on October 2009 approved the introduction of BT brinjal the second GM crop and the first genetically modified food crop of India.[xlv] Although many environmentalists, agronomists, farmer’s bodies, scientists from various fields and even some state governments opposed the introduction of BT brinjal, the GEAC approved the commercialization of BT brinjal.[xlvi] This approval of BT brinjal is based on the report of an expert committee formed by GEAC. Soon after its establishment, it was noticed that out of 16 members of the committee 5 were directly connected with Monsanto. At this point in time, many organizations raised opposition regarding the composition of this expert committee (EC).[xlvii] Ignoring all the protests and also ignoring its harmful effect on humans, environment, and animals EC approved the introduction of Bt Brinjal.[xlviii] It was estimated that the damage caused by the BT brinjal was around $221 million that was approximately 50-70 Percent in economic terms.
Soon after that, people started to pressurize the central government to form a law by which the authority of MOEF would transfer to DST on the matter of commercialization of biotechnology products.[xlix] Since DST backed the commercialization of GM crops from a very long time and the technocratic and corporate bodies have an influence over DST. They wanted DST to be the main body which regulates this matter and for the same reason, BRAI bill 2013 was introduced.[l]
Another Effort: Biotechnology Regulatory Authority of India (BRAI) bill, 2013
The BRAI bill was proposed by MOST.[li] On 22nd April 2013, it was introduced in Lok Sabha and was passed. The bill was drafted keeping in mind India’s obligation to the Cartagena Protocol[lii] on Biosafety 2000, which make sure of the safe and responsible utilization of biotechnology.[liii] The BRAI Bill has the objective “to promote safe utilization of biotechnology”.[liv] It was passed in the Lok Sabha but was lapsed in the Rajya Sabha. There are some key features of the bill mentioned below which will explain if at all India needed this bill.
The bill sets up the Biotechnology Regulatory Authority of India, an independent authority, to deal with and to regulate products and organisms of modern biotechnology.[lv] This bill envisioned to regulate the transport, containment, research, import, manufacture, environmental release, and utilization of biotechnology products.[lvi]
Scientific experts undertook a multi-level process of assessment which was to be followed in order to get regulatory approvals from BRAI. It had to be certified by BRAI that the developed product was safe for its intended use and all the laws and regulations governing that product will continue to be applicable to it.
An appellate body named Biotechnology Regulatory Appellate Tribunal was established by the bill in order to hear appeals from the orders and decisions of BRAI and also to hear any civil case pertaining to a substantial question with respect to modern biotechnology.[lvii] The bill also had the provision of penalties which states that penalties will be given in case of performing unauthorized field trials, giving false information to BRAI, impersonating or obstructing an officer of BRAI and for breaking any other provisions of the bill.
The BRAI bill had its objective of promoting the safe use of technology. But the question arises whether a regulation for promoting a technology was even necessary? Regulation was required for the protection of environment, health, and livelihood of people from the harmful effect of biotechnology.[lviii] The bill ignored this particular criterion and failed to mandate it.
It is said that the promoters can’t be regulators because there arises an inherent conflict of interest.[lix] The BRAI bill was proposed by DRT under the MOST, a ministry which is responsible for promoting biotechnology in India. In that situation, the promoters of biotechnology had a major role in the functioning of biotechnology and also in organizing the sector regulator.[lx] In this scenario, the regulation and promotion of GM crops under the same ministry led to a conflict of interest.
The bill talked about the jurisdiction of the tribunal on the matter of “substantial question of modern biotechnology” without signifying “modern biotechnology” due to which there were extensive flexibility and ambiguity.[lxi]
The tribunal established by the bill consists of 5 technical members and 1 judicial member. This particular clause of the bill was not in consonance with the decision laid down by the Supreme Court, that a bench of the tribunal can’t have more technical members than the judicial members.[lxii] The BRAI bill centralized the authority and decision-making power in a narrow technical body and denied the authority of institutions such as Panchayat Raj over health, agriculture and natural resources.[lxiii] It was considered against the federal polity enshrined in the constitution of India and the powers given to the Panchayat Raj Institution.
The bill had its implication and encroachment on matters which were examined by other independent laws, some were Biological Diversity Act, 2002,[lxiv] Environment Protection Act, 1986,[lxv] Forest Conservation Act, 1980,[lxvi] Nagarpalika Act, 1992,[lxvii] Food Safety and Standards Act, 2006,[lxviii] Forest Rights Act, 2006,[lxix] Panchayat Raj Act, 1993,[lxx] Right to Information Act, 2005,[lxxi] Drugs and Cosmetics Act, 1940[lxxii] and also had an overriding effect on the other laws. This particular provision of the bill was completely against the constitution of India as Indian constitution clearly states that parliament before making any law on the matter of state list has to take prior permission of state legislative assembly.[lxxiii] Because state legislative assemblies have the authority to deal with matters concerning agriculture and plant disease as per item 14 of state list.
India is a signatory to Nagoya protocol which is a supplementary protocol on Liability and Redress to the Cartagena Protocol on Biosafety.[lxxiv] Nagoya protocol provides international rules and regulations with respect to liability and redress when we talk about the cost and damages incurred by LMOs and GMOs. Also, it is clearly stated in this supplementary protocol that parties (countries) are allowed to make domestic laws and should have a procedure in dealing with liabilities either by specific or civil laws when any damage caused by GMOs.[lxxv] But India failed to comply with these provision in BRAI bill because the bill only talks about the liability of providing false information to the board and didn’t discuss any liability arising from the negative impacts of biotechnology products to the environment or human health.
Thus the failure of BRAI bill has raised various questions on the aspects of lawmaking in India. Inter alia, firstly, should law jeopardize the rights and interests of the people in the event of instantaneous development, secondly, is it not necessary to include no-fault liability or absolute liability when that development is meddling with the environment[lxxvi] and thirdly, who will be responsible to clean up the mess and compensate those who have been victims of the accident?[lxxvii]
Post that, the draft ‘Regulations and guidelines on biosafety of recombinant DNA research and biocontainment, 2017’ has been prepared after various consultations. This new rule assures to meet the international standards in biotechnology and will also fill the gaps left by the older legislation. The objective of this draft is to ensure that national authorities and institutions and all parties are well informed or have access to information on safety and handling of hazardous microorganisms, genetically engineered organisms or cells.[lxxviii] The practical application of the draft is yet to be seen because every older law which failed to deal with the protection of environment was due to its failure of implementation. It should be understood that we do not require new laws but have to find ways for proper implementation.
Because usually the problem arises when the technology tries to commercialize itself in the name of environmental safety and sustainability as discussed in the case of BT Cotton and BT brinjal.
This problem has been rightly discussed by the philosopher A.A. Brennan who argues that the main difficulty in forming decisions relating to environmental problem is our dishonesty, It is neither unfair nor unkind to governments, public agencies and corporations to observe that we are a long way from full honesty in our debates and deliberations on the environment.’[lxxix]
The dishonesty exists in people and they empower it by tolerating a narrow analysis of science and mythic depictions of our circumstance, both of which encourage ‘self-deception’ and ‘incontinence’.[lxxx] The principal myth he features is that of reinstating nature, after human interventions, for example, mining, industrialization, and so forth. There is a strong belief that, given the correct innovation or technology, we can reinstate nature to its primitive condition. The dishonesty lies in an inability to perceive that the project isn’t as environmentally considerate as it shows up. All the more regularly such activities are given an environmental gleam as a method for appropriating funds for the patent on the modified seeds, or, all the more basic, as a method for upgrading the publication record of an institution as methods for increasing more noteworthy power and impact in a specific area of research.[lxxxi] The possibility of dishonesty in the use of environmental language to cover up consumerist interests has to be exposed.[lxxxii]
[i] India Brand Equity Foundation, Advantage India, Biotechnology (March, 2017), https://www.ibef.org/download/Biotechnology-March-2017.pdf.
[ii] Rahul Koul, Mission $100 Billion by 2025: National Biotechnology Development Strategy 2015-2020 Unveiled, BioSpectrum (Feb. 10, 2015), https://www.biospectrumindia.com/news/73/8369/mission-100-billion-by-2025-national-biotechnology-development-strategy-2015-2020-unveiled.html.
[iii] Biotechnology Industry In India, India Brand Equity Foundation (July, 2017), https://www.ibef.org/industry/biotechnology-india.aspx
[iv] Id.
[v] Frequently Asked Questions (FAQs) On the Cartagena Protocol, The Biosafety Clearing-House (BCH) (Feb. 29, 2012), http://bch.cbd.int/protocol/cpb_faq.shtml.
[vi] National Research Council, Agricultural Biotechnology: Strategies for National Competitiveness, Washington, DC: The National Academies Press (1987), https://doi.org/10.17226/1005.
[vii] Gigesh Thomas & Johan De Tavernier, Farmer-Suicide in India: Debating the Role of Biotechnology, 8 Life, SCIENCE, Society and Policy 13 (May 11, 2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427059/.
[viii] Id.
[ix] Nidhi Uppangala, Potential Risks of Agriculture Biotechnology, Biotech Articles (June 29, 2010, 8:57 PM), https://www.biotecharticles.com/Issues-Article/Potential-Risks-of-Agriculture-Biotechnology-192.html.
[x] Charles, Benefits and Risks of Biotechnology, Biotechnology forums (Dec. 18, 2012, 02:11 PM), https://www.biotechnologyforums.com/thread-1926.html.
[xi] Kiruthika D, A Critical Analysis of the Biotechnology Authority of India, Academike (Nov. 13, 2015), https://www.lawctopus.com/academike/biotechnology-regulatory-authority-bill-2013/.
[xii] Saravanan A., The Biotechnology Regulatory Authority of India Bill, 2013- A Threat To the Safety of India’s Food and Farming, Biotechnology Law Report (2016), https://doi.org/10.1089/blr.2016.29031.as.
[xiii]About the Nagoya Protocol, Convention on Biological Diversity, https://www.cbd.int/abs/about/.
[xiv] 199 G. J. V. Nossal & Ross L. Coppel, Reshaping Life: Key Issues in Genetic Engineering (3rd ed. Cambridge University Press 2002).
[xv] Ministry of Science & Technology, The Department Of Biotechnology Has Been Headed By Several Formidable Scientists since Its Birth in 1986, Department of Biotechnology (Feb. 10, 2018), http://www.dbtindia.nic.in/creation-of-dbt/#.
[xvi] Dr. Manoj S. Rohilla, Dr. Suman Govil & Dr. Purnima Sharma, Pursuit Of Biotechnology Opportunities & Options, Department of Biotechnology (2015), http://www.dbtindia.nic.in/wp-content/uploads/PGTP-2015_LR.pdf.
[xvii] Dr. Anitha Ramanna, India’s Policy on Genetically Modified Crops, Asia Research Centre Working Paper 15 (2006), http://www.lse.ac.uk/asiaResearchCentre/_files/ARCWP15-Ramanna.pdf.
[xviii] Dr. Vibha Ahuja & Dr. Geeta Jotwani, The Regulation of Genetically Modified Organisms in India, Biosafety Clearing-House (2007), http://bch.cbd.int/database/attachment/?id=780.
[xix] Id.
[xx] Bhuvan Bhaskar Jha & Ashutosh Shankar, Evaluating the Law on Genetically Modified Crops in India, Manupatra (2017), http://docs.manupatra.in/newsline/articles/Upload/F622B184-AACE-4235-9188-00A4C07AD9DD.%20Bhuvan%20Bhaskar%20Jha%20&%20Ashutosh%20Shankar__Civil.pdf.
[xxi]Chapter VI Biosafety- Indian Law, Policy and Practice, Shodhganga (2018), http://shodhganga.inflibnet.ac.in/bitstream/10603/18185/12/12_chapter%206.pdf.
[xxii] Supra note 19.
[xxiii] Julia Freeman, Terre Satterfield, & Milind Kandlikar, Agricultural Biotechnology and Regulatory Innovation in India, 4 Science and Public Policy 38, (May 1, 2011): 319, 322.
[xxiv] Hugh Dang, Brad Gilmour, & Nawal Kishor, India’s Agri – Biotech Policies, Regulations, and Decision-Making, 1 AgBioForum 18, (2015): 87, 94.
[xxv]Ananth Padmanabhan, R. Shashank Reddy & Shruti Sharma, Modern Biotechnology and India’s Governance Imperatives, Carnegie India(Oct. 2, 2017), http://carnegieindia.org/2017/10/02/modern-biotechnology-and-india-s-governance-imperatives-pub-73253.
[xxvi] Lok Sabha Secretariat, 37th Report on Cultivation of Genetically Modified Food Crops – Prospects and Effects (2012), Ministry of Agriculture, http://agrariancrisis.in/wp-content/uploads/2012/08/1208-GM_Report.pdf
[xxvii] Id at 73–74.
[xxviii] Id at 74.
[xxix] Supra note 29.
[xxx] GAIN Rep. No. IN6157, at 6 (2016), U.S. Department of Agriculture Foreign Agricultural Service, 5, 10.
[xxxi] FSSAI Interim regulation on Operationalising GM Food regulation in India, 2010, Food Safety and Standards Authority of India (hereinafter FSSAI) (India).
[xxxii] Mayank Aggarwal, GEAC to Hold Meet on Issue of Genetically Modified Processed Foods Import, Livemint, (May 9, 2017), http://www.livemint.com/Politics/oithfZU0JhOOlODByMwaHL/GEAC-to-hold-meet-on-issue-of-genetically-modified-processed.html.
[xxxiii] G Seetharaman, GM Crops: Government Should Set Up an Independent Regulator at the Earliest, Economic Times, March 27, 2016.
[xxxiv] Sayantan Bera & Nikita Mehta, Regulation of Biotech in India Is Not Predictable: Michael Frank, Livemint, (September 18, 2015), http://www.livemint.com/Companies/7eJodHBjdI4iCKseKtno7K/Regulation-of-biotech-in-India-is-not-predictable-Michael-F.html.
[xxxv] Pushpendra Kumar Gupta, Bhagirath Choudhary & GodelieveGheysen, Removing BT Eggplant from the Face of Indian Regulators, 33 Nature Biotechnology, (2015): 904–6.
[xxxvi] Supra note 25.
[xxxvii]108 Joseph J. Molnar & Henry Kinnucan, Biotechnology and the New Agricultural Revolution (Westview Press 1989).
[xxxviii] Joseph Yaffe, Agricultural Biotechnology: Implications for the Environment and the Family Farmer, 15 Environs Environmental Law & Policy Journal 2, (1992).
[xxxix] Paras Chopra & Akhil Kamma, Genetically modified crops in India-The Current Status of GM Crops in India, http://www.deskuenvis.nic.in/pdf/gm.pdf.
[xl] Sharat Karekatt, One of The World’s ‘Most Evil’ Company is Behind 3 Lakh Farmer Suicides in India, Youth ki Awaaz (Oct. 14, 2015), https://www.youthkiawaaz.com/2015/10/farmer-suicides-in-india-and-gmo-crops/.
[xli] Id.
[xlii] Keith Kloor, The GMO-Suicide Myth, 30 Issues in Science And Technology 2, (2014).
[xliii] Supra note 41.
[xliv] Supra note 41.
[xlv]MOEF, Decision on Commercialization of Bt-Brinjal, Ministry of Environment and Forests, http://www.moef.nic.in/downloads/public-information/minister_REPORT.pdf.
[xlvi] Supra note 13.
[xlvii] Supra note 27.
[xlviii] Leo Saldhana & Bhargavi Rao, Creating an Undemocratic and Unaccountable Biotechnology Regulator, Environment Support Group (Nov. 29, 2011), http://www.esgindia.org/campaigns/brinjal/press/brai-bill-2011-esg-critique.html.
[xlix] Partho Sarathi Ray, Biotechnology Regulatory Authority of India Act: The New Weapon of the Second Green Revolution, Sanhati (January 16, 2012), http://sanhati.com/excerpted/4523/.
[l] Id.
[li] Supra note 13.
[lii]Cartagena Protocol on Biosafety (CPB),Ministry of Environment, Forest and Climate Change, www.moef.nic.in/division/cartagena-protocol-biosafety-cpb.
[liii]Shweta Mohandas, How the Biotechnology Regulatory Authority of India Bill will affect your dinner, Lawfarm (July 27, 2016), https://www.lawfarm.in/blogs/how-the-biotechnology-regulatory-authority-of-india-bill-will-affect-your-dinner.
[liv] The Biotechnology Regulatory Authority of India Bill, No. 57 of 2013, PRS India (2005), http://www.prsindia.org/billtrack/the-biotechnology-regulatory-authority-of-india-bill-2013-2709/.
[lv] Id.
[lvi] The Biotechnology Regulatory Authority of India Bill 2013, India Environment Portal (April 22.2013), http://www.indiaenvironmentportal.org.in/content/374314/the-biotechnology-regulatory-authority-of-india-bill-2013/.
[lvii] Supra note 13.
[lviii] BRAI Bill, 2013 – India’s Monsanto Promotion and Protection Act?, Sustainable Agriculture Campaigner, Greenpeace India, http://www.indiaenvironmentportal.org.in/files/file/BRAI-Monsanto-briefing.pdf.
[lix] Vishwanath Kulkarni, Bill on independent regulator for biotech sector introduced in Lok Sabha, Economic Times, April 22, 2013.
[lx] Jay Mazoomdaar, Biotechnology Regulatory Authority: The Bill That Will Decide What You Eat, Firstpost Budget 2018 (June 17, 2013, 5:03 PM), http://www.firstpost.com/blogs/biotechnology-regulatory-authority-the-bill-that-will-decide-what-you-eat-877863.html.
[lxi] Supra note 56.
[lxii] Madras Bar Association v. Union of India & Anr, Writ Petition (C) NO. 1072 OF 2013.
[lxiii] Supra note 56.
[lxiv] The Biological Diversity Act, No.18 of 2002, lawmin (1961).
[lxv] The Environment (Protection) Act, No. 29 OF 1986 india code (1993).
[lxvi] Forest Conservation Act, No. 69 of 1980, india code (1993).
[lxvii] Nagarpalika Act, 1992, india code (1993).
[lxviii] Food Safety and Standards Act, No. 34 of 2006, fssai (2006).
[lxix] The Forest Rights Act, No. 2 of 2007, india code (1993).
[lxx] Panchayat Raj Act, 1993, india code (1993).
[lxxi] Right to Information Act, No. 22 of 2005, india code (1993).
[lxxii] Drugs and Cosmetics Act, No. 23 OF 1940, india code (1993).
[lxxiii] India Const. art. 249, § 1.
[lxxiv] Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to The Cartagena Protocol on Biosafety, Secretariat of The Convention on Biological Diversity Montreal (2011), https://Bch.Cbd.Int/Database/Attachment/?Id=11064 pdf.
[lxxv]Restrictions on Genetically Modified Organisms: International Protocols, library of congress (September 6, 2015), https://www.loc.gov/law/help/restrictions-on-gmos/international-protocols.php.
[lxxvi] Supra note 55.
[lxxvii]Suman Sahai, The cropped-out GM tag, DNA (Feb. 3, 2015, 5:00 AM), http://www.dnaindia.com/analysis/column-the-cropped-out-gm-tag-2057645.
[lxxviii] RCGM Secretariat Ministry of Science and Technology Government of India, REGULATIONS AND GUIDELINES ON BIOSAFETY OF RECOMBINANT DNA RESEARCH AND BIOCONTAINMENT, Department of Biotechnology (DBT)(2017), http://www.dbtindia.nic.in/wp-content/uploads/draft-biosafety-regulations-and-biocontainment-guidelines-2017-ff.pdf.
[lxxix] A.A. Brennan, Environmental Dilemmas: Ethics and Decisions 1-19 (R.J. Berry Ed., Chapman and Hall, 1993).
[lxxx] Celia E. Deane-Drummond, Genetic Engineering for The Environment: Ethical Implications of The Biotechnology Revolution, Chester College of Higher Education, https://core.ac.uk/download/pdf/364044.pdf.
[lxxxi] Id.
[lxxxii] Id.
