The Biotechnology Regulatory Authority of India Bill, 2013

Bill will set up an independent authority

Authority will regulate products and processes of Biotechnology and certify that the product is safe

Regulation

o Research

o Trails

o Manufacture

o Transport including import and export

o Use

Bill doesn’t 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

o Ex: Bt Cotton which produces an insecticide that kills certain pests that eat it or production of

synthetic insulin for human consumption

Currently biotechnology is regulated by

o Ministry of Environment and Forests

o Department of Biotechnology under Ministry of Science and Technology

Biotechnology is governed under the rules of The Environmental Protection Act 1986

How BRAI will work / the institutional setup?

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.

BRAI will comprise of three units:

o 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)

o 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

o 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

the three regulatory divisions

o agriculture, forest and fisheries

o human health and veterinary products

o industrial and environmental applications

Each of these will be headed by a Chief Regulatory Officer (CRO)

Disputes will be heard at Biotechnology Regulatory Appellate Tribunal

Tribunal will have civil jurisdiction

Appeal against the tribunal will be made in Supreme Court

Tribunal will consist of 1 judicial member and 5 technical members having expertise in Biotechnology

Biotechnology Regulation Present Scenario

Biotechnology has its benefits and drawbacks

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 BRAI 2013 Bill

Kind of Authority Govt departments give approval Independent statutory body gives approval

Activities

regulated

Trails Research

Manufacture

Transport including import and

export

Use

Trails

Manufacture

Transport including import and export

Use

Oversight of the

research process

Every entity conducting research needs to

setup Institutional Biosafety Committee

Statutory body will do

Approval Bodies Final approval by Genetic Engineering

Appraisal Committee (GEAC)

Single regulator comprising of a number of

units such as

the RAU, PRC and EAP

Regulatory

divisions

No provision Three divisions:

(i) agriculture, forests and fisheries;

(ii) human health and veterinary; and

(iii) industrial and

environmental applications

Assessment of

environmental

impact

GEAC approves proposals for release of

products into the environment including

field trials

EAP

Qualification of

regulators

Ministry officials and representatives of

government scientific/technical bodies

Individuals with scientific expertise in the area

of

biotechnology

Monitoring and

enforcement body

No provision Enforcement Unit will enforce decisions of

BRAI and ensure compliance with rules and

regulations

State and district

level bodies

State body investigates and takes action

for violation of law through the State

Pollution Control Board. District

committee monitors safety regulations in

installations engaged in the use of such

products

State body is the nodal agency for interaction

between the state government and BRAI.

No provision for district level body.

Public

participation

No provision Decisions of BRAI will be made public and

public scrutiny will be invited

Judicial body Authority to be notified by MoEF. National

Green Tribunal (NGT) has jurisdiction in

Appeals to be heard by the Biotechnology

some cases. Regulatory

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.

Australia has set up an independent regulator

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

USA and Canada have not specified any liability

Australia and Norway in its statute regulating biotechnology, has specified strict liability for genetically

modified organisms

Recommendation of Various Committees

Swaminathan Task Force on Agriculture

An autonomous regulatory commission should be created with expertise in Biotechnology and Biosafety

Work of the committee (testing, evaluation and approval) should be scientific

Agriculture is a state subject, a state body should be there to bring cohesiveness with the centrl body

CD Mayee Committee on Bt-Cotton

Regulatory Committee should have technical expertise

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

Mashelkar Committee on Recombinant Drugs

Overlap in approval process of GEAC and Drugs Controller General of India has led to ambiguity

An independent regulator is needed

Supreme Court on Agriculture

Independent regulatory system is required

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 state’s 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