India’s Monsanto Protection Act – Dr. Vandana Shiva

Posted on Friday, May 3rd, 2013

India’s Monsanto Protection Act

The Biotechnology Regulatory Authority of India (BRAI) Bill 2013

By Dr Vandana Shiva

Immediately after the then Minister of environment Jairam Ramesh announced a moratorium on BT Brinjal, a Biotechnology Regulatory Authority of India (BRAI) suddenly emerged . BRAI could not be passed in 2010 and 2011 because of objections by citizens and parliament, but it has surfaced again as a 2013 Bill.

While it is presented as a Biotechnology Regulation Act, it is in fact a Biotechnology Deregulation Act, designed to dismantle the existing Biosafety regulation. That is why ,in the area of Food and Agriculture it can be called India’s Monsanto Protection Act that gives corporations like Monsanto immunity by freeing them of courts and democratic control under our federal structure, just like the US Monsanto Protection Act through which Monsanto sneaked in section 735 under the HR 993 Act to give itself immunity.

The proposed Biotechnology Regulatory Authority Bill of India, 2013 BRAI) which is a new version of the older BRAI 2011 , BRAI, 2009 and the National Biotechnology Regulatory Bill, 2008, is a recipe for deepening the regulatory chaos as well as deepening the crisis created by conflict of interest issues related to issues of genetic engineering. It is a law to subvert the existing Biosafety Regulation under the EPA, and deregulate GMOs.

In the opening paragraph of the Bill it is stated that the Bill is drafted to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

Firstly, India had a Biosafety Law put in place in 1989, fourteen years before the Cartagena Protocol came into force. That is why we did not need to create a new Law to implement the Biosafety Protocol. The BRAI is an attempt to dismantle the 1989 Law, and replace it with a Law for fast track promotion of GMOs. The proposed BRAI is in total denial of the existing Law. The proposed Law pretends we do not have a Law under the EPA.

The BRAI will also deepen the regulatory chaos. In response to a case we had filed in the Supreme Court on the safety of GM crops, the Government’s response was that the Food Safety and Standards Act, 2006 would address the lacunae in Biosafety Regulation. We now have another proposed Authority. And this is in addition to the existing Biosafety Law under the Environmental Protection Act 1986 (EPA) titled “The Rules for the Manufacture, Use / Import / Export and storage of hazardous micro-organisms / genetically engineered organisms or cells”, 1989. The substantial parts of what the BRAI will cover are already covered by the EPA rules. These include the regulation of –

  1. Any genetically engineered plant, animal, microorganism, virus or other animate organism that may have application in agriculture, fisheries (including aquaculture) forestry and food production

  2. Any genetically engineered plant, animal, microorganism, virus or other animate organism used as food

  3. Any animal clones that may have application in agriculture, fisheries or food production

It also includes DNA vaccines, transgenic blood, products of synthetic biology etc.

Secondly, the Environment Ministry is the nodal Ministry for the Convention on Biological Diversity and the Cartagena Protocol. Even if we did not have a Biosafety Law under the EPA, which we do, it would be the Ministry of Environment that would be the responsible Ministry to implement International Law. The Department of Biotechnology and the Ministry of Science and Technology cannot usurp this role. They are the promoting Ministry and Department, and promoters and developers cannot be regulators.

Conflict of Interest

The conflict of interest issues had become a major concern because the panel which approved the Bt. Brinjal included some of the scientists involved in its development. That is why the public hearings were organized by the Ministry of Environment. As the Minister of Environment observed in his statement justifying the moratorium “while there may be a debate on the nature and number of tests that need to be carried out for establishing human safety, it is incontrovertible that the tests have been carried out by the Bt. Brinjal developers themselves and not in any independent lab. This does raise legitimate doubts on the reliability of the tests.”

The Department of Biotechnolgy has signed the MOU with Australia’s Queensland University to develop GMO bananas over 10 years, when safe and local alternatives exist which are 3000% percent more efficient in providing iron than the GMO banana will be.

The proposed BRAI is an attempt to take the conflict of interest to the structural level by making the department and Ministry that promotes biotechnology, in charge of the regulation of Biosafety. This is equivalent to asking the wolf to protect the sheep. For this reason alone, Parliament should reject the Bill to set up BRAI.

BRAI is the naked attempt of the biotechnology industry to shift GMO regulation to the Biotechnology Department in addition to promoting biotechnology. Since 1997-98, when Monsanto first brought in Bt. Cotton seeds illegally to the country, it used the Department of Biotechnology, and the RCGM to cover up the illegal activities of the Biotechnology industry. Its powers were to be restricted to framing guidelines for good lab practices. It has overstepped its powers and used guidelines to undermine clauses of the 1989 EPA Law. When we filed a case in the Supreme Court in 1998 to stop Monsanto’s illegal introduction of Bt. Cotton seeds, it is the DBT/RCGM which gave approval, even though all deliberate release of GMOs is to be approved by GEAC. DBT / RCGM arbitrarily decided to call field trials contained experiments, even though GM crops planted in fields are a deliberate release. DBT has undermined science to rush GMOs to the market. Its track record shows that it cannot be trusted with Biosafety issues. The DBT has been trying to erode the Biosafety structures since 1997-98. Now it is going all the way to hijack and usurp the work of the Environment Ministry and to illegally undermine the 1989 EPA Law, through the proposed BRAI.

Violation of the Constitution, Threat to Federal Structure

BRAI is also an attempt to usurp the powers of the States guaranteed by the Constitution under our federal structure, and under the rules for GMO regulation under EPA are based on State Biotechnology Coordination Committees which have powers to inspect, investigate and take punitive action. It was under these powers 13 states banned BT Brinjal, Kerala could adopt a GMO free policy, and Bihar could order the uprooting of illegal GMO corn trials of Monsanto.

BRAI aims at taking these powers away. Article 2 imperially announces “It is hereby declared that it is expedient in the public interest that the Union should take under its control the regulation of organisms, products and processes of modern biotechnology industry” even though this is unconstitutional ,since agriculture is a State Subject, and GMOs in Agriculture fall in that jurisdiction.

The powers of the State under the EPA Rules for Biosafety are being taken away, and the State Biotechnogy Regulatory Advisory committees have no legal powers, only the role of “interaction” with the Central Authority. In effect the Federal Structure under the constitution is being destroyed to give fast track approval for GMOs on a national scale.

Shutting the doors to justice

Further, BRAI is taking disputes arising from GMO beyond the scope of an independent judiciary and civil courts.The Central Government will set up an Appellate Tribunal.

Article 56 states “the Appellate Tribunal shall have the jurisdiction over all civil cases where a substantial question relating to modern biotechnology is involved”

It is because we could go to the Courts, the Research Foundation for Science, Technology and Ecology could stop the Commercial release of BT cotton from 1999 to 2002. It is because of the current case before the Supreme Court that a Technical Expert committee has been able to recommend that there should be a moratorium on Bt crops for 10 years , and a ban on all GMO crops of which we are a centre of diversity.

BRAI intents to close the doors of justice through article 56.

The 1989 Biosafety Law is an excellent science based framework legislation. What needs improvement is its elaboration and elevation to an independent Biosafety Act, its implementation, and the strengthening of the working of the GEAC as democratic , interdisciplinary body of independent experts and citizens.

The BRAI Bill is an attempt to silence the debate, hijack the policy space and the regulatory process so that those who have subverted science and democracy can have undemocratic power to decide the fate of the nation.

This cannot be allowed. It will lead to a dictatorship of the biotechnology lobby and the biotechnology industry.

It is a direct assault on Food Democracy.

Regulation through EPA Rules 1989

Deregulation through BRAI 2009

Ministry in charge of Regulation

Ministry of Environment and Forests which is the modal Ministry for biosafety nationally and internationally in the Cartagena Protocol on Biosafety to the UN Conventional on Biological Diversity.

Ministry of Science and Technology, Department of Biotechnology. This means that the biotechnology promoting department will be the regulator. This is an institutional conflict of interest. BRAI is presented as if it is the implementation of the Cartagena Biosafety Protocol, and gives the false impression that there is no Biosafety Law in India. It makes no reference to the EPA Rules 1989, either in the preamble or in Schedule II about amendments in related laws. This is an illegal and misleading replacement of an existing law.



The EPA Rules 1989 have multi-layered regulation through competent authorities. These include –

  1. Recombinant DNA Advisory Committee (RDAC) to review scientific developments and recommend appropriate safety regulations.

  2. Review Committee on Genetic Manipulation (RCGM), a committee in the Department of Biotechnology including representatives of – (a) Department of Biotechnology, (b) Indian council of Medical Research, (c) Indian Council of Agricultural Research, (d) Council of Scientific and Industrial Research, (e) other experts

  3. Institutional Biosafety Committee (IBSC) to govern biosafety at the institutional level under guidelines of RGCM and keeping District Level Committee / State Biotechnology Coordinating Committee and Genetic Engineering Approval


  1. Genetic Engineering Approval Committee (GEAC) a body under the Department of Environment, Forests and Wildlife to look at environmental aspects of all research and industrial production. The GEAC is also responsible for approval of proposals relating to GMO releases into the environment including experiments and field trials. GEAC includes representatives of Ministry of Environment, Department of Biotech, ICMR, ICAR, CSIR etc.

  2. State Biotechnology Coordination Committee (SBCC) which will have power to inspect, investigate and take primitive action in case of violations (Art. 15)

  3. District Level Committee (DCC) to ensure safety at District Level.

THE BRAI will have all power centralized in one authority with a Chairperson / Chief Executive with a doctorate degree in Life Sciences (seed biotechnology and genetic engineering) or post graduate degree in Medical Science. Ecological expertise is deliberately excluded, revealing that the proposed act is for biotechnology promotion, not biosafety regulation.

The committee for selection will also be dominated by biotechnologists with no one from the Ministry of Environment.

Given scandals like the  2G scam in telecommunication and the oil scam in which the hydro-carbon regulator himself was involved, we know what we can expect from the centralized unaccountable power of a Biotechnology “Regulator”. In the case of telecom and oil, some people got rich. In the case of GMOs, without proper biosafety regulations we risk ecological and public health disasters.

Besides destroying biosafety, the proposed regulation destroys decentralized democratic governance. GMOs in agriculture need the State involvement since agriculture is a State subject in our Constitution. 13 States refused to have Bt. Brinjal. Nitish Kumar, Chief Minister of Bihar objected to GM corn trials without the States permission. As a result, Environment Minister Jairam Ramesh issued a notification requiring State approval become GM trials.

The statutory State Biotechnology Coordination Committee has been replaced by a State Biotechnology Regulatory Advisory Committee to merely interact with the authority, not to independently regulate as in EPA 1989, especially to implement penalties.  


EPA, 1989 is governed by Code of Civil Procedure and allows access to

the justice system.  

BRAI will set up an appellate Tribunal which shall not be bound by the procedure laid down by the Code of Civil Procedure 1908 (Art. 56), it will replace Courts, thus denying justice to citizens concerned with biosafety.


Penalties on violation of biosafety by those releasing

Punishing the public (Art. 62) whoever provides information or produces any document that is misleading. This clause can be abused to silence all critics, given that Monsanto can turn scientific truths into falsehoods, and falsehoods into science. While critics will be fined Rs. 5,00,000, corporations that carry out illegal trials will only be fined only Rs. 2,00,000 (Art. 63).



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