18 Jun 2013, Rahul Koul, BioSpectrum
The Genetic Engineering Appraisal Committee (GEAC) of India was reconstituted on March 11, 2013, following which the industry heaved a huge sigh of relief. The decision from India's environment ministry came only after repeated criticism by the industry as well as certain ministers within the government. The last meeting of the GEAC took place on April 11, 2012, and since then there were no fresh clearances given to any field trials for Genetically Modified (GM) crops.
A recent meeting under the chairmanship of Mr Hem Pande, additional secretary, ministry of environment and forests on March 22, 2013, decided that several issues, which require the attention of the GEAC, would have been taken up.
As per the agenda listed out for the meeting, apart from the clearances to field trials of various GM crops, it also take stock of the status of writ petition in the context of interim report submitted by the Technical Expert Committee (TEC) constituted by the Supreme Court. Also, the 16-member committee reviewed 22 applications for extension of validity period or change in the location.
The co-chairman of GEAC, Prof. Sudhir Kumar Sopory, vice chancellor, Jawaharlal Nehru University, when contacted by BioSpectrum said that he was unable to attend the meeting and he didn't elaborate the reasons for the same. The mails to GEAC chairman and other members went unanswered. The apparent reason perhaps is the clause in the committee's terms of references that mentions the undertaking by the members on not revealing any confidential information.
Industry welcomes the move!
While most of the industry representatives believe that GEAC is very important for the timely clearances of the GM crops for field trials, there are a few who think that mere clearance by a regulatory body is of no great help. This is because they have to then look for clearances from state governments to go ahead for conducting field trials.
Reacting to this, Dr N Seetharama, executive director, Association of Biotechnology led Enterprises-Agriculture Group (ABLE-AG) said, "It is surely a right decision that has come on a right time. The vacuum created in between had to be filled as soon as possible."
Sharing her views, Dr Usha Zehr Barwale, chief technology officer, Mahyco said, "The GEAC certainly is very important for all of us to get clearances for GM crop trials. Therefore, it is a welcome move as there is a lot that is on stake for the agribiotech companies. "
"It is good news and will bring cheer to the industry. The void created by the non functional GEAC will have to be filled and cases that need attention be addressed as soon as possible," said Dr Seetharam Annadana, traits development and vegetable R&D management lead, Syngenta South Asia.
Do GEAC require a makeover?
Dr S R Rao, senior advisor, Department of Biotechnology, feels that this is a routine process of reconstitution and nothing can be read into it. "The committee functioning will remain as it was mentioned earlier," he said. Dr Rao feels that making Biotechnology Regulatory Authority of India (BRAI) bill in itself was a marathon test and agrees that sustainable strategy is very much required for the agribiotech sector.
Many think that the regulatory structure, as well as the GEAC as a body must undergo a quick revamp. "At present, we all know that the regulatory structure is very complex and we have to bear with the same system for the time being. However, I am equally hopeful that the government will put the resolution of the issue on fast track mode. We hope that the pending BRAI bill would soon be tabled in the parliament and the new better regulatory system will replace this existing one," pointed out Dr Seetharama of ABLE-AG.
Echoing similar sentiments, a former member secretary of GEAC and now a prominent member of the industry told BioSpectrum that unless the structure of the regulatory body doesn't undergo change, it will continue to function in the way it used to. He in particular pointed out that GEAC meetings have to be organized more frequently and more seriously. "The body has to be more vocal about its status and importance," he said on condition of anonymity.
An insider in the committee mentioned that GEAC's decisions on allowing of trials are still not 100 percent complete as they need to get further approvals at the state level and the clearances come at official's whims and fancies. "GEAC is like a toothless tiger," remarked the expert.
Dr Seetharama noted that the top priority before the industry association is to hold meetings with the principal secretaries of various state governments to make them realize that the laboratory testing by state government is not required, when that has already happened once at the central level.
"Our immediate concern is to get permission for states to conduct GM crop research trials. That includes No Objection Certificates (NOCs) for biosafety level one and two trials as already approved by GEAC in the past, and those likely to be permitted based on last month's GEAC meeting, the minutes of which are being eagerly awaited. In this connection, we have already started contacting state governments all over again. Thus, one of the major concerns of the industry is to seek permission for testing GM crop cultivars without losing much time-already two precious years have been lost, which translates into enormous cost to the industry, and a much larger opportunity cost to the country," stated Dr Seetharama.
Speaking recently at an industry event, Dr Swapan Kumar Dutta, deputy director general, crop science, Indian Council for Agricultural Research (ICAR) and a member of reconstituted GEAC remarked, "I strongly believe that GEAC would have to work in a different manner. Scientific questions must be answered by scientists and not by persons with non scientific attitude. It is very important that these issues be understood from a scientific perspective as GM crops are potentially inevitable."
Streamlined regulations are still a distant dream!
In her recent reference to GM crops in the parliament, Ms Jayanthi Natarajan, minister of state (independent charge) for environment and forests, stated that the government is following a policy of case-by-case approval of GM crops. "Just in case the transgenic crop is not found suitable for release in the environment or human consumption, the product is rejected during the trial stage itself. A final view on the commercialization of GM plants is taken only when there is a clear economic and technical justification for release of the product," the minister said.
"In the absence of consensus, a final decision on the issue may take from couple of months to several years. Therefore, it is not feasible to furnish any tangible time period at present. The final decision on the matter, whenever available will be put up in public domain," she had mentioned.
Though the industry may not very happy about it, Dr Annadana, sees a ray of hope in the minister's words. He says, "At least she has mentioned that biosafety is the only concern and I feel that we should agree with her on that count. Nobody would like to release an unsafe product in the market. Its just that scientifically sound justification must be given while rejecting the applications or stalling the ongoing trials."
Dr V R Kaundinya, managing director, Advanta India, feels that the regulatory policy has to be conducive for investments. "Regulatory policy is not a static policy. It needs to be upgraded with time and it must be done immediately," he said.
With the GEAC back in business again, it is expected that the industry-at least for the time being-can look up to some agency for the clearances and redressal of issues. Having so much investments at stake in various field trials, the decision, no doubt will help the regulatory body to get back on track yet again.