Centre Admits Deaths in Clinical Trial of GE Drugs
The Hindu
August 22, 2004

New Delhi: The Centre has admitted before the Supreme Court that some patients died during the clinical trials of genetically engineered (GE) drugs by two pharma companies.

This reply was filed by the Ministry of Environment and Forest responding to a PIL filed by an NGO - Adar Destitute and Old People Home (ADOPH) - alleging that two firms conducted human trials of GE drugs without prior approval.

Though the Ministry conceded that human trials were conducted without prior approval of Genetic Engineering Approval Committee (GEAC), it hastened to add that ex-post facto approval for the two GE drugs, r-streptokinase and r-human insulin, have been granted by the Committee condoning the procedural lapse.

The affidavit of the Ministry filed through advocate Vijay Panjwani said that the Rs 600 crore Bangalore-based pharma company, Biocon India Ltd, had obtained the approval of all competent authorities under the applicable rules to undertake clinical tests of r-human insulin.

Therefore, the Environment Ministry on July 14 condoned the procedural lapse by Biocon India in not seeking approval.

In the advent of the biotechnology wave, a number of companies have mushroomed in India claiming technological capability to manufacture products through re-combatant technology wherein genetically engineered organisms are used to manufacture drugs for human use, the petitioner had said.

The NGO had alleged in spite of being fully aware of the fact that Biocon was going ahead with the human trials without the permission of GEAC, the Government machinery turned a blind eye and failed to take any step.

The Ministry said "the circumstances under which the approval of GEAC was not obtained prior to conduct of Phase III clinical trial has been examined at length by the GEAC."

It said "after examining all aspects of the case the GEAC has condoned the procedural lapse and accorded approval of manufacture and marketing of r-human insulin by Biocon."

Regarding the clinical trials of r-Streptokinase by pharma company Shanta Biotech, the Ministry said the GEAC found no evidence of any deliberate attempt on the part of the company to short circuit the GEAC clearance.

"Taking into consideration that r-Streptokinase is a life saving drug, the GEAC decided to condone the procedural lapse by the company and accorded ex-post facto approval for phase-III clinical trials," it said.

On the death of patients during human trial, the Ministry said "the overall mortality in the clinical study is significantly less than international norms."

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