Govt proposes five-member biotech regulator

The proposed Biotechnology Regulatory Authority will comprise a five-member panel of experts.

New Delhi: The proposed Biotechnology Regulatory Authority will comprise a five-member panel of experts who will have the final say in deciding the "safety and efficacy" issues of genetically-modified crops leaving no scope for political interference in this field.

The Biotechnology Regulatory Authority of India (BRAI) Bill, being given final touches by the Law Ministry, is likely to be tabled in the Budget Session of Parliament next year.
A five-member panel of experts would form the BRAI that will have powers to decide on safety and efficacy of genetically modified products -- be it medicines or plants.

However, a final decision on commercialisation of the product would vest with the respective controllers like the Drug Controller General of India in case of medicines, senior officials of the Department of Biotechnology (DBT) said.

The DBT is piloting the Bill to set up the BRAI, which will replace the Genetic Engineering Appraisal Committee and the Review Committee on Genetic Modification.

The Board of Governors, with representatives from 13 ministries involved in the regulation of biotech products, and the Biotechnology Regulatory Advisory Council will be the two arms of the BRAI. The Council will have representatives of all the stakeholders, including farmers associations, consumer organisations and NGOs.

The Board of Governors, comprising Secretary rank officers, will be headed by the Secretary, Department of Science and Technology.

The BRAI will also identify labs where trials ongenetically-modified products could be carried out, results of which will form the basis of appraisal of the product.

"We hope to halve the time taken for product appraisals once the BRAI come into being," M K Bhan, Secretary, Department of Biotechnology told reporters here.

Once an application for product appraisal is received, the Risk Assessment Unit (RAU) will analyse the data related to it and make recommendations, from here the product ruling committee takes over and makes its observations.

The matter is then put up before the five-member BRAI who take a final decision regarding the safety and efficacy of that particular product.

After the decision is announced all related documents regarding the product, barring those covering intellectual property rights and commercial issues, will be kept in the
public domain for comments.

The Bill also has provisions for setting up an appellate body, to be headed by a retired Supreme Court judge, for redressal of grievances of the applicant.

Since various wings of the BRAI will require "extreme specialists" in regulation matters, the DBT has also proposed to set up a training school for those working with it.


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