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LATEST NEWS UPDATES | Biotech regulator bill up for Cabinet nod

Biotech regulator bill up for Cabinet nod

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published Published on Nov 17, 2010   modified Modified on Nov 17, 2010

A bill to put in place the proposed biotechnology regulator is likely to be taken up for consideration by the Cabinet at its meeting on Thursday. The proposed Biotechnology Regulatory Authority of India (BRAI) seeks to replace the existing multiple mechanisms that are operating under different administrative ministries.

The proposed bill — initially prepared in 2008 — has been now revised substantially. The proposed authority will now deal only with safety and efficacy issues, leaving the decisions on commercialisation of biotech products to respective administrative ministries.

Depending on the field in which the product is to be used, the decision on commercialisation will be taken either by the agriculture ministry, or environment ministry, or health ministry. In some cases, the approval may also be given by the department of science and technology.

The curtailed mandate appears to be on account of conflict of interest and turf wars in the government. The environment ministry had raised issues about placing the biotech regulator under the administrative control of the department of biotechnology. It was argued that the promoter of biotechnology should not be allowed to perform the role of the regulator as well.

The regulatory authority will now be under the administrative ambit of the department of science and technology. However, concerns on the conflict of interest still persist as traditionally, the same minister heads departments of biotechnology and science and technology.

On the insistence of the environment ministry, public consultation has been made mandatory before an approval is granted to use of a biotechnology product.

The proposed authority will function under the supervision of an inter-ministerial governing board, which will comprise of secretaries of the ministries of agriculture, commerce, health, environment, department of science and technology, biotechnology.

The compromise was hammered out between the environment ministry and department of biotechnology in August. The reworked authority will continue to give the environment ministry a fair amount of control in the approval and use of biotechnology products in the country.

As per the agreement, the Genetic Engineering Approval Committee (GEAC), currently housed in the environment ministry, would now be rechristened as the Environment Appraisal Panel under the proposed BRAI. The panel will be governed by the Environment Protection Act in managing and protecting the environment. The chairman and member secretary of this panel will be nominated by the environment ministry.

The chairman of the environment appraisal panel will report directly to the BRAI chairman. In the event of a difference of opinion between the panel and the regulator, the BRAI will pass a speaking order. Similarly, the expert member on environment in the product ruling committee will be selected from a roster prepared jointly by the environment ministry and the BRAI.

The health ministry had raised objections about the proposed regulatory authority when it was taken up for Cabinet approval in August. Health minister Ghulam Nabi Azad had said that his ministry had not been consulted. The health ministry stands to lose turf with the proposed regulator subsuming the biotechnology-related functions of the Drug Controller of India.

The health ministry’s intervention could also reopen the issue of conflict of interest. It has been suggested that the regulator be parked in a neutral ministry, as in the case of the Commissioner for Railway Safety. This office is housed in the ministry of civil aviation. The other option is to place the regulator under the Cabinet Secretariat as in the case of the National Authority, Chemical Weapons Convention.


The Economic Times, 18 November, 2010, http://economictimes.indiatimes.com/news/politics/nation/Biotech-regulator-bill-up-for-Cabinet-nod/articleshow/6944283.cms


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