Centre Admits Deaths in Clinical Trial of GE Drugs
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
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
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
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
"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
On the death of patients during human trial, the Ministry said "the
overall mortality in the clinical study is significantly less than
FAIR USE NOTICE. This document contains copyrighted material whose use has not been specifically authorized by the copyright owner. India Resource Center is making this article available in our efforts to advance the understanding of corporate accountability, human rights, labor rights, social and environmental justice issues. We believe that this constitutes a 'fair use' of the copyrighted material as provided for in section 107 of the U.S. Copyright Law. If you wish to use this copyrighted material for purposes of your own that go beyond 'fair use,' you must obtain permission from the copyright owner.