Date:27/07/2004 URL: http://www.thehindubusinessline.com/2004/07/27/stories/2004072702720600.htm

Back Genetic panel nod for most Phase-III trials

Our Bureau

New Delhi , July 26

THE Genetic Engineering Approval Committee (GEAC) has given a go ahead to nine pharmaceutical companies for conducting Phase - III clinical trials and three companies to manufacture and market their products.

The regulatory body has also rejected an application from a company seeking waiver on conducting Phase-III clinical trials.

The Government has given a cautionary approval for "limited import" for r-human interferon by the New Delhi-based Kee Pharma Ltd from a Chinese company. Kee Pharma had sought approval for import and marketing of the above drug from the China-based Tianjin Hualida Biotechnology. Interferons are used in illnesses such as hepatitis B and C, cancer.

The GEAC has also rejected Kee Pharma's request for waiver of Phase-III clinical trials of r-interlukin 2, which is basically used to treat various types of cancer. The GEAC has taken this decision based on similar decisions in the past.

"The contention about difficulties in availability of sufficient number of patients for conducting phase III clinical trials on the grounds of rarity of disease, in a country such as India, was not found tenable. Duration of the treatment and high cost cannot be a consideration as a basis for exemption from clinical trials," the GEAC has stated.