Fbae Logo
Home | | Support Us | Contact Us
Goals & Objectives Our Position False Propaganda Special Topics Important Publications Important Links Events news Biosafety
Fbae Header Home





Stop Talking, Just Do it!

Dr. Shanthu ShantharamWednesday, September 08, 2004

Indian Biotech Regulatory Reforms close on the heels of the global biotechnology conference in Delhi sponsored by FICCI, MSSRF and ISAAA, every Tom, Dick and Harry has spoken on the need for reforming the biotechnology regulatory system in India. Some say Indian biotech regulatory system is too lax, some say it is too tough and yet some say it is inept and ineffective. Perhaps, there is some truth in all of these. But, is there a solution to the problem? There is, but not the way they are going about it. Indian bureaucracy has invented the phrase "single window" clearance system as a cure all for every ill of the permit and license raj system. It meant different things to different people. What it meant to Kapil Sibal, the Minister of State for Science and Technology when he suggested the government would have single-window system for biotechnology is anybody's guess! At least one anti-GM activist thinks that it means lessening the regulatory burden and making it easier for the industry. The rest don't think so. It simply means providing administrative convenience of sending in your biotech application through one door without having to run from pillar to post. It does not mean that all the confusion and the turf battle within and among the ministries are over. In fact, it has just begun with ICMR throwing its hat into the ring. It certainly does not mean that the regulatory review will be speeded up, as the system itself has not been designed to put a timely process in place. It will take a long time. Then, there is a suggestion that GM crops must be covered by insurance to protect the poor Indian farmer. There is also a demand for socio-economic and ethical impact assessment of the technology and the products. Can you imagine all these issues being handled by a regulatory system that was originally cobbled together to assess biosafety and environmental impact of GM crops? There is no way all these issues can be handled by a regulatory system whose ostensible purpose is to assure the public of the safety of biotechnology and its products. This is not to say that other issues are not important, but it is just that these issues should be decided by specialized experts. Socio-economic and ethical issues are best studied by academic experts and scholars. And after a thorough public discussion and discourse a suitable public policy must be evolved to determine if those issues are best handled through a regulatory regimen.

For now, India is struggling to put in place a scientifically rigorous biosafety and environmental impact assessment system and that is not hard to do in this day and age with so much of resource and expertise available around the world just for asking. Biotechnology regulatory oversight is not rocket science. Countries around the world have been doing it for decades now and if India is serious, it can call in experts to put together an effective and transparent regulatory review system for GM crops quickly and get on with the business of safe biotechnology development, pronto! Almost everyone who is talking on biotech regulatory system in India has not even read an environmental risk assessment document, much less carried out one.

It is no ones case that GM crops do not need regulatory oversight. The squabble is about the level of regulatory scrutiny that should be conferred on GM crops. How does one decide the level of regulatory scrutiny? By simply preparing an ex-ante risk assessment using the best possible scientific rigor and determining the specific risks and then exploring the options to manage or mitigate those risks in a cost effective way. It is equally important to assess the risks of not deploying the GM option as well. GM crops cannot and should not be considered "risky" just because some feel it is risky. All of us would be wiser to realize that regulatory oversight has a cost and it better be cost effective regulations. Otherwise, we will be denying the potential benefits of the technology by making it prohibitively expensive. To the best of my knowledge, no one in RCGM or GEAC has prepared an environmental risk assessment document for any of the of GM crops, based on which they have made their regulatory decisions so far. Surely, they have done their own "seat of the pants" review of some kind or other so far. Because it was not systematic and followed any standard methodology, it took more than six years to get the first GM Bt-cotton to the market place.

Civil society groups are crying about lack of transparency and I suspect even the applicants would appreciate a dose of the same to comply with the regulatory requirements. I suspect that the lack of transparency in the system is because they cannot explain the rational for making their decisions. Having been an author of thousands of environmental risk assessments, I can confidently tell that there is no need to hide anything about regulatory decisions on GM crops, as there is nothing to hide. Both the regulators and the applicants must do everything possible to make as much data and information public as possible. Both must realize that in this day and age when the GM crop technology is under so much of fire, everyone involved must do everything possible to assuage public concerns and do not do it just to satisfy some activists. Kiran Mazumdar-Shaw of Biocon must be congratulated for her boldness to announce the other day that Biocon has made all its clinical tests data public through its website. The agricultural biotech industry should follow the lead of Biocon in this regard and earn public trust and confidence. They can really beat the activists in their game by winning over the public directly.

The government is wasting its time by talking to people who are clueless about setting up a regulatory regimen. The only sane and balanced view I have heard in all this cacophony is an editorial entitled "Biotech Watchdog-A Single Regulator' a welcome idea" in the pages of The Financial Express datelined August 15, 2004 (http://www.financialexpress.com/fe_full_story.php?content_id=65882). Lobbying by one group or another to influence the regulatory system will continue, but the policy makers and administrators know better to put competent people in-charge and give them a free hand to do the right thing.

The need of the hour is a statutorily independent national biotechnology regulatory commission that will serve as a policy advisory body and administer a technically competent group of regulatory experts with training in environmental risk assessment. The commission's members can be drawn from different walks of life with adequate representation from all the stakeholders to ensure transparency for which everyone is crying. It will go a long way in earning pubic trust and confidence and facilitate biotechnology development for the benefit of all.

Dr. Shanthu Shantharam is the President of a biotechnology affairs consulting firm, Biologistics International in Maryland, USA.

Related News Articles

Bt-corn does not harm biodiversity

Countering insect resistance with designer Bt toxins

ICGEB receives grant from the Bill & Melinda Gates Foundation to strengthen and expand biosafety systems in sub-Saharan Africa

Policy on the transfer of Genetically Improved Farmed Tilapia (GIFT) from Asia to Africa by the WorldFish Center

Rules on marketing GM produce face review

EU ministers to debate Bayer's GM cotton, soybeans

EU's legal labyrinth of GMO legislation


The latest issue of Plant Physiology (July 2008; Volume 147, Issue 3) has a special section on next generation of biotech crops especially on nutritional improvement.  These papers can
be downloaded free!

Influence of Transgenosis on the Plant-Insect- Relationships, in Particular on Chemically       Mediated Interactions

Effect of Transgenes Conferring Enhanced Pathogen Resistance on the Interaction with Symbiotic        Fungi in Rice

Impact on the Soil Ecosystem through Natural and Genetically Engineered Organisms:
      Effects, Methods and Definition of Damage as Contribution to Risk Assessment

The Decomposition of Bt-Corn on the Fields and its Impact on Earthworms and on other        Macroorganisms in the Soil

Environmental Post-market Monitoring of Bt-maize:
       Approaches to Detect Potential Effects on Butterflies and Natural Enemies

Columns by Dan Gardner

Against the Grains: 'The Terminator Hoax '

Decisions taken in the 84th Meeting of the Genetic Engineering Approval Committee

Brazilian Health Biotech: Fostering Crosstalk Between Public and Private Sectors

Biotechnology Related Article Appeared on 'Samyukta Karnataka' ( Regional Language )
June 12, 2008.

Nothing Left to the Imagination

The Politics of GM Food
Kirit S Javali

Hi-tech seed factories: Sowing Seeds of Success

"Indian Seed Industry is Well Placed to Serve Both Domestic and International Markets"
Dr MK Sharma,
Managing Director,
Mahyco Monsanto

"If we Facilitate Seed Industry, we Facilitate Growth in Agriculture"
Dr Govind Garg,
Krishidhan Seeds

Metagenomics: Window to the Microbial Universe

Few Checks to Prevent Entry of GM Food

Gene Campaign Criticises India’s ‘Silence’ at Global Bio-Safety Meet

An Enforceable International Compact for Infectious Diseases

"Indian Science in Genomics has been Able to Place Itself on the Global Map"

Indian Gene Decoded

The Development of RNAi as a Therapeutic Strategy

FAO E-Conference on Biotechnologies and Water Scarcity

Genetic Landscape

Biotechnology in Food and Agriculture

RH Nature Reviews Genetics 08- Opposition to Transgenic Technologies

Germany: Discussion Paper of German Ag-Industry about EU Biotech Policy Implications

Bt maize performance in Spain

Arsenic speciation varies with type of rice

Why I Am Bothered by Neo-Colonialist NGOs

China experts identify gene for yield, height in rice

The French government has called for a debate on the review of the EU
The World Trade Organisation (WTO) has also repeatedly criticised the EU for "undue delays" in the authorisation of GMOs. See the latest WTO ruling:

The legal bans are in France, Austria, Poland, Hungary and Greece.

EU delays decision on approving more GM crops

UCR Geneticist Plays Scientific Advisor to Movie about “Love, Adventure and ... Genetically Modified Rice”

Gujrat worst-hit by illegal Bt cotton production

Farmers seek ban on GM crops

Call for policing
Ijaz Ahmed Rao discusses the virtues of a bio-safety framework for genetically modified crops, now that they have become farmers’ favourite

Stem cells: The 3-billion-dollar question

Genes as the solution

Food crisis spurs research spending

Global Food Crisis / UN / Bilingual Transcript of Statements by Secretary-General, Heads of Concerned Agencies, and Response to Questions at Press Conference on Global Food CrisisGM Crops, A World View

Mass Protests against GM Crops in IndiaInterference at the EPA

Open letter to Robert B. Zoellick, President, World BankNew BT variety may push short staple cotton output.

The future of agricultural biotechnology: Creative, destruction, adoption, or irrelevance? ICABR Conference 2008

Soaring food prices and global grain shortages are bringing new pressures on governments, food companies and consumers to relax their longstanding resistance to genetically engineered crops.

Prof. Kameswara Rao and Dr. T.M. Manjunath's Participation in 2008 Biotech Activities

Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest

LEADER: Nurturing nanotech

Center for Indigenous Knowledge for Agriculture and Rural Development

Scientists find potential schistosomiasis treatment

Islamic conference boosts S&T with new resolutions

Mexico publishes GM approval guidelines

Uganda 'close to stamping out Hib meningitis'

New method 'prevents spread of GM plants'

Social factors 'help women with post-tsunami stress'

Women scientists celebrated in new charter

Sub-Saharan Africa news in brief: 13–25 March

Brazil creates US$18 million fund for young scientists

Health weeks 'powerful tools' for deworming children

Rotavirus vaccine, not treatment, 'cheaper for Panama'