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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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