In a timely intervention the Indian Council of Medical Research (ICMR) "has suggested stringent norms for ensuring health safety and has proposed vesting of more powers with the health ministry and the agencies operating under it."

A recent report from ICMR noted, "The safety of these components of the genetic construct is not clearly known as they have the potential to induce toxicity, transfer to gut flora or produce unintended effects leading to changes that are relevant from toxicological/nutritional perspective. Specific safety issues associated with GM foods include direct or indirect consequences of new gene product or altered levels of existing gene product due to GM, possibility of gene transfer from ingested GM food and potential adverse effect like allergenicity and toxic effects."
http://www.lobbywatch.org/archive2.asp?arcid=4177
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ICMR Proposes Gene Technology Regulator
ASHOK B SHARMA
Financial Express, Monday, August 16, 2004
http://www.financialexpress.com/fe_full_story.php?content_id=66046

NEW DELHI, AUG 15: The Indian Council of Medical Research (ICMR) has proposed setting up of a National Gene Technology Regulator for ensuring safe applications and use of transgenic technology. It has suggested stringent norms for ensuring health safety and has proposed vesting of more powers with the health ministry and the agencies operating under it.

The suggestions of the ICMR are timely as the Union minister for science and technology, Kapil Sibal recently announced putting in place a single window regulatory body for transgenic crops and products and a national biotechnology policy by January 2005. The minister made this announcement while inaugurating the 'International Conference on Agricultural Biotechnology: Ushering In The Second Green Revolution' on August 10, the three-day global conference was organised jointly by the Federation of Indian Chambers of Commerce and Industry (FICCI), International Service for Acquisition of Agri-Biotech Applications (ISAAA) and the MS Swaminathan Research Foundation (MSSRF).

ICMR's suggestion of a regulatory body is, however, different from that suggested by the MS Swaminathan panel on agriculture biotechnology applications.

The Swaminathan panel recommended setting up of an autonomous National Biotechnology Regulatory Authority comprising of five experts from five different disciplines. It sought to reduce the role of the existing regulator, Genetic Engineering Approval Committee (GEAC) under the Union environment ministry and vest some more powers with the promoter agency, Indian Council of Agriculture Research (ICAR).

In this context, the ICMR suggested that the proposed National Gene Technology Regulator should have overall mandate of regulating the use of biotechnology products - plants, microbes, animals or drugs. The regulator should protect the health and safety of the people and the environment by identifying and managing risks posed by transgenic technology. "Perhaps this could be achieved by designating one of the ministries for this purpose," the ICMR study said.

Outlining its proposals, the ICMR study entitled ‘Regulatory Regime for Genetically Modified Foods : The Way Ahead’ said that the mechanism of implementation of the environment ministry’s notification needs to be developed with those concerned with food control activities. It suggested that various factors pertaining to food safety should be looked after by the health ministry at stages of application, commercial release, import and post-market surveillance. The study called for for a mechanism to oversee "genetically modified (GM) foods that are imported into the country and GM foods that are marketed in the country after import or even GM foods clandestinely grown without undergoing the proper approval process." It suggested that the Union health ministry with its existing infrastructure is best suited to administer this role.

The ICMR study called for a separate enactment making mandatory for providing information on imported GM foods.

The study said that the health ministry needs to set up a special committee on novel foods as part of the existing central committee for food standards (CCFS) to be chaired by the director-general of ICMR or his nominee. All applications including that for labelling received by the Review Committee on Genetic Manipulation (RCGM) of the GEAC should be referred to this proposed special committee on novel foods.

The special committee on novel foods will examine every stage like application for in-house development, environmental release, import, commercial cultivation and trials. Special studies on GM foods should be carried out in laboratories designated by ICMR.

The study said, "In India there is a need to compulsorily label a food if it contains novel DNA/protein or has altered characteristics. However, it need not cover some foods like refined edible oils and the food ingredients added in minor quantities.

The imported food, too, should be subjected to labelling regulations. It should have certificate of origin indicating GMO status and proof of analysis from certified laboratories." The study said that information should be shared with civil societies but they should not be a part of the regulatory process.