Data on clinical trials of genetically-modified (GM) brinjal have been made public by the Genetic Engineering Approval Committee (GEAC) of the environment ministry.
The development comes even as Maharashtra Hybrid Seeds Company (Mahyco) had filed a petition before the Delhi High Court to prevent disclosure of the details of clinical trials on GM brinjal by the Review Committee on Genetic Modification of the Department of Biotechnology (DBT).
Since the Mahyco litigation is considered by the industry as well as public interest groups as a test case for deciding the fate of exclusive data shared by companies, especially pharmaceutical and agri-business entities, with the government for regulatory approvals, the GEAC decision has raised questions about the “confidentiality” claims made by research-based companies on their clinical trial data.
While GEAC gives marketing approvals for genetically-modified products, the research of such products are scrutinised by the review committee.
The move has come as a welcome surprise for global environmental watchdog Greenpeace, which has been trying to get the details of the clinical trials for an independent scrutiny for the last 30 months.
Mahyco said it continued to believe in the confidentiality of the clinical trial data that is submitted to government agencies for regulatory approvals. DBT officials said the court case has no relevance as the data, which were termed as confidential, are now in public domain.
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It has been close to 30 months since the first application for the bio-safety data and minutes of the DBT committee meetings were submitted under the RTI Act 2005 by Divya Raghunandan of Greenpeace. Since then, the DBT had been denying the data till the Central Information Commission in November 2007 directed the department to disclose it.
A month later, Mahyco, the Indian seed partner of the multinational agri-biotech giant Monsanto, obtained a stay order over the disclosure of data on grounds that the company could suffer commercial losses if the confidential data is disclosed to public. The case is still being heard by the high court.
Greenpeace activists said the public disclosure has proved that the claims of Mahyco on “confidentiality” were unnecessary and it was a “criminal wastage of time for the CIC, the courts and NGOs for the last 30 months”.
“We have submitted data for our trials and experiments to GEAC, which has decided that data pertaining to trials that are complete will be put on its website.
However, the data of ongoing trials will not be disclosed. Mahyco has always believed in protecting only confidential data and proprietary information from competitive interests,” Mayco spokesperson Mahendra Sharma said.