Chennai: The way in which the Genetic Engineering and Approval Committee (GEAC) has gone about approving field trials of genetically modified crops, as also the final approval for commercial cultivation, has been questioned by P.M. Bhargava, the former Director of the Hyderabad-based
Centre for Cellular and Molecular Biology.
 
Dr. Bhargava who was appointed a special invitee to the GEAC in February this year at the instance of the Supreme Court to bring about more transparency has been very critical of the regulatory body's rationale for accepting the results of biosafety studies generated by the applicants.
 
The minutes of the GEAC meeting held on May 28 has taken note of his disapproval of the way the committee has been relying on the data generated by the applicant and hence its usefulness. However, it has defended itself by noting that accepting the data provided by applicants, as in the case of pharmaceutical companies, is a common practice.
 
The minutes note that "... it will be unfair to mistrust the samples and data generated by the applicant, without any basis."
 
"The clinical trial data [for a drug] is not generated by one lab. And the trials are almost always multicentric [conducted in many locations]. All the procedures of the trials are so well documented and the preclinical trials [toxicity testing done on animals prior to starting the trials in humans] can be replicated by anyone," stressed Dr. Bhargava. "All these don't happen in the case of GM safety testing."
 
But the biggest difference is that most of the human clinical trials for testing drugs are double blinded. This makes sure that neither the person conducting the trial nor the volunteers will know if he has been given a drug or a placebo. And the volunteer recruitment is done by the centres conducting the trials.
 
This does not happen in the case of GM testing. None of the tests done were double blinded. The samples were provided by the companies. "Do the institutes conducting the tests have the facility to check if samples provided by the companies are indeed genetically modified samples and
not non-GM ones," he asked.
 
Despite the numerous checks and balances to ensure human clinical trials are conducted and reported correctly, the number of instances where the pharmaceutical companies engage in misconduct are aplenty.
 
Many measures have been taken to make the conduct of clinical trials more transparent, thus giving less scope for any malpractice. The pharmaceutical companies based in the U.S. are now required to make clinical trial results available in the government database. "So what happens when no such monitoring mechanisms exists for testing GM crops," he asked.
 
"There is a great need for a central dedicated institute for collecting and conducting all GM related safety tests," he said. "The institutions where the tests were done have not been set up for looking at the safety of GM crops." There is a pressing need for such an institute as there are more GM food crops lined up for testing.
 
If the procedure for approving drugs is strict, the basis for approving GM crops should be stringent as food is consumed by animals and a large number of people when compared with drugs. And unlike drugs, GM crops cannot be recalled from the market once they are produced.
 
"See what happened with hyacinth plants and parthenium weeds," he said.
"There is a world of difference between drugs and GM crops."