The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests has taken serious note of the practice among some pharmaceutical companies to conduct clinical trials of recombinant drugs without its approval. The Committee is to look into all such cases, where trials were conducted without prior approval of GEAC.

The recent meeting of the committee emphasized the need to observe prescribed procedures with regard to the approval of clinical trials of recombinant products in the country. It felt that the companies had overlooked the statutory requirement due to a revised procedure that was prepared by the Department of Biotechnology and displayed on DBT website during 2003-04. The procedure was silent on the role of GEAC thereby causing many companies to bypass GEAC approval while undertaking clinical trials. The committee notes, "in a number of cases, phase-III clinical trials have been conducted without prior approval of GEAC. One such request had also been received for ex-post facto approval and the GEAC has been considering this matter on a case-to-case basis."

Since these lapses were mostly caused due to the amended procedure displayed by DBT, the committee has requested its DBT representative to furnish details of the sanctions made during the period. It is known that the revised procedures were displayed before it was officially put in force thereby leading to the confusion. The GEAC will now look into all the cases which were approved by the Review Committee on Genetic Material (RCGM) during that period.

The objections raised by GEAC against the conduct of phase III clinical trials of r-streptokinase by Shantha Biotechnics was mainly countered by the company by highlighting the clauses of this amended procedure.