The Hindu Business Line : Clinical trials of GM organisms — Pharma cos may be exempted from seeking clearance

THE Government is likely to exempt pharmaceutical and biotech companies from seeking Genetic Engineering Approval Committee (GEAC) clearance for undertaking clinical trials in the case of "purified products" of genetically modified organisms (GMOs).

This is in line with what a joint committee comprising officials from the Department of Biotechnology and the Ministry of Environment and Forests, has suggested to the national task force headed by the CSIR Director-General, Dr R.A. Mashelkar. The joint committee was set up to streamline the regulations for recombinant-DNA pharmaceuticals.

This move will primarily decrease the number of steps in the clearance procedure for pharmaceutical companies.

The draft submitted by the committee is in two parts. While one part addresses issues aimed at providing immediate relief to the industry; the other has suggested formation of an independent regulator for the industry - a step that could be taken on a relatively long-term basis, according to Government sources.

As a part of the immediate measures, the committee has suggested the GEAC approvals should be limited to those products that use "GMOs per se" or those products that involve living modified organisms, among others. The joint committee recently submitted its recommendations to the national task force. The task force is yet to put its final stamp of approval on the recommendations.

Purified GMOs are essentially proteins and are used in drugs such as vaccines, interferons and diagnostics, say experts. The committee was asked to suggest changes in the regulatory mechanism for use of recombinant organism during various stages of testing, manufacturing, import and use.

The Ministry had set up the task force headed by Dr Mashelkar in April 2004 to streamline the regulatory process involved in the approval of all recombinant DNA products. Apart from Dr Mashelkar, the task force includes Secretaries of the Ministry of Environment and Forests, the Department of Biotechnology and the Ministry of Health.

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