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Authority will regulate products and processes of Biotechnology and certify that the product is safe
Regulation
o
Research
Trails
Manufacture
Use
Bill doesnt specify for any liability, the tribunal and the court will decide the liability
Biotechnology
o
Is about manipulation of genetic structure of organisms. This results in change in specific traits
Ex: Bt Cotton which produces an insecticide that kills certain pests that eat it or production of
synthetic insulin for human consumption
Biotechnology is governed under the rules of The Environmental Protection Act 1986
Field trials of the modified products (which could be organisms) will only be conducted after permission
from BRAI
For a drug or vaccine with elements of biotechnology, the Central Drugs Standard Control Organisation
(CDSCO) will forward the application to BRAI to assess whether it is safe to proceed with a clinical trial.
Clinical trials will continue to be regulated by the CDSCO under the Drugs and Cosmetics Act, 1940.
The Bill amends the Food Safety and Standards Act, 2006, which regulates the manufacture, import, sale
and distribution of food items. The amendment mandates that food items with elements of biotechnology
have to be approved by BRAI as safe for human consumption
BRAI will not disclose confidential commercial information made available to it in an application for
authorisation. This is regardless of anything contained in the Right to Information Act, 2005.
Risk Assessment Unit (RAU): The RAU will undertake science - based safety assessments of the
applications (applications seeking authorisation for research, transport, import, manufacture or
use of products and organisms of biotechnology)
Product Rulings Committee (PRC): the report of the RAU will be forwarded to the PRC and the
PRC will make recommendations regarding the safety of the product or organism
Environmental Appraisal Panel (EAP): BRAI may refer an application to the EAP, in case of
products or organisms having an environmental impact
BRAI will constitute an Enforcement Unit consisting of monitoring officers for enforcing its decisions
Tribunal will consist of 1 judicial member and 5 technical members having expertise in Biotechnology
Benefits of this technology include the introduction of characteristics such as drought resistance, pest
resistance, or high iron content in a plant
Risks include adverse impact on the health of organisms that consume these products, and the
environment and biodiversity.
Any regulatory structure for the sector will need to balance the benefits with the risks and ensure the safe
use of biotechnology
The Bill envisages an independent scientific risk assessment to be undertaken by experts in the field of
biotechnology.
Comparison of the current regulatory approval system under the 1989 rules with the regulatory approval
system proposed under the Bill
Parameter
Current
Kind of Authority
Activities
Trails
Research
regulated
Manufacture
Trails
Manufacture
export
Use
Use
Oversight of the
research process
Approval Bodies
units such as
the RAU, PRC and EAP
Regulatory
No provision
Three divisions:
divisions
(i)
(ii)
(iii)
industrial and
environmental applications
Assessment of
EAP
environmental
impact
field trials
Qualification of
regulators
of
biotechnology
Monitoring and
No provision
enforcement body
level bodies
Pollution
Control
Board.
District
No provision
participation
Judicial body
Regulatory
some cases.
Appellate Tribunal.
International Regulations
The Convention on Biological Diversity and the Cartagena Protocol on Biosafety mandate rigorous
scientific regulation to ensure safe use of biotechnology
In USA and Canada, the government departments of agriculture, health, environment and food regulate
biotechnology. Both countries use existing laws and agencies rather than creating a specialised regulatory
mechanism.
Determination of Liability
The primary function of liability regimes is to provide compensation to affected parties and incentivise the
industry to minimise the risks of adverse impact. There are different types of liability regimes. In some
cases, liability is specified in a law (statutory liability). In other cases, courts decide that the polluter
should compensate
The Bill does not specify any liability regime. Therefore, it will remain open to the courts to determine the
general civil liability arising out of any adverse impact of modern biotechnology.
The Nagoya Supplementary Protocol has stated that countries should have a liability regime for living
modified organisms
Australia and Norway in its statute regulating biotechnology, has specified strict liability for genetically
modified organisms
An autonomous regulatory commission should be created with expertise in Biotechnology and Biosafety
Agriculture is a state subject, a state body should be there to bring cohesiveness with the centrl body
Agriculture is a state subject so state agricultural department and institutions as universities should be
involved in testing, evaluation, approval and monitoring of field trials
Overlap in approval process of GEAC and Drugs Controller General of India has led to ambiguity
Regulators should implement a robust scientific review mechanism through a dedicated and qualified
team
Mandatory consultation should be held with states to seek permission for field trials. Most of the
responsibility for the maintenance and operation at the field level should be given to the states.
Controversy
Though the Bill brings the regulation of biotechnology under the powers of the Union. So, the states are
objecting that Union is trying to infringe the states right for example in case of agriculture. The Centre
claims that the states will still have the powers to intervene in issues like GM technology as agriculture is
something that belongs to the State list
The draft Bill attempts to bypass the Right to Information Act (RTI) under the garb of being Confidential
Commercial Information. Activists say that biosafety information cannot be confidential and the
Supreme Court has already set a precedent for this in the Bt Brinjal case. RTI has time and again helped
activists and civil society expose or get information on field trials of GMOs at various areas, which will be
impossible if BRAI becomes law.
Conflict of Interest: The ministry of Science and Technology, which is in charge of promoting genetically
modified organisms in India like it promotes any other science and technology venture, is the regulating
authority as the draft Bill proposes to set up the BRAI under the ministry. Activists view that as a clear
case of conflict of interest. The Bt Brinjal file sailed through various ministries, including science and
technology, without a hitch. It was stalled by the environment ministry alone. Now the government is
trying to give a fast track single window clearance for genetically modified organisms through this Bill
Deviation from Task Force Report: The task force on agricultural biotechnology, headed by M S
Swaminathan, laid six cornerstones. They include well being of farming families, economic and
environmental sustainability, bio-security and trade security. None of these has been taken into account
while drafting the Bill.
Ashutosh Katiyar