NEWS FROM INDIA
1.'Genetic contamination' raises an alarm
2.Farmers and experts called for moratorium on GM crops
3.'State should lead the fight against GM food'
4.Bayer threatens affordable drugs in India

EXTRACTS: Suman Sahai, convenor of Gene Campaign, says that "even the fact that GM rice could get out of their trial site is damning for Mahyco. Nor is it clear if the GM rice introduced by Mahyco is safe for human consumption. It isn't known how far it has spread but the contamination has surely begun." This violation, she adds, is all the more serious because India is the centre of origin of rice with immense genetic diversity. (item 1)

Both Dr Bhargava and Dr Chaudhury charged that there was a dangerous nexus between regulatory authorities, bureaucrats, politicians and multinational corporations which can utterly compromise the health of Indian people. (item 2)
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1.SCIENCE: GM RICE 
It's Gene Rummy 
'Genetic contamination' raises an alarm
Outlook, February 2 2009   
http://www.outlookindia.com/full.asp?fodname=20090202&fname=ZGM+Rrice&sid=1
 
Genotypical Risk
*Genetic contamination of surrounding fields from unsafe trials could pollute natural crops.
*Not certain if GM food safe for human consumption.
*EU, Japan banned US rice in 2006 on discovery of genetic contamination.
*Alleged contamination of rice fields in Jharkhand needs investigation.

What was long feared may finally turn out to be true. Genetic contamination of natural crop strains because of unsafe field trials of GM crops has reportedly begun in Jharkhand, if Gene Campaign, a Delhi-based research group, is to be believed. It alleges that seed company Mahyco was careless in its field trials of GM rice in Saparong village, Ranchi district. This, Gene Campaign says, led to a second generation of illegal GM rice in and around the trial fields.
To back its claims, Gene Campaign cites a report by Gene Scan - a German laboratory””that confirms the presence of the Cry1Ac gene (isolated from a bacillus and introduced in Mahyco's GM rice to create resistance to borers) in the samples of rice grain and leaf that were sent to them for analysis by the group.

These samples, it says, were sourced in September '08, after the trials were over from second-generation rice plants that had come up in and around the trial site. It is mandatory that test sites are isolated to avoid any contamination and trial crops burnt to avoid any GM regrowth. The group says Mahyco did not follow these rules.

Suman Sahai, convenor of Gene Campaign, says that "even the fact that GM rice could get out of their trial site is damning for Mahyco. Nor is it clear if the GM rice introduced by Mahyco is safe for human consumption. It isn't known how far it has spread but the contamination has surely begun." This violation, she adds, is all the more serious because India is the centre of origin of rice with immense genetic diversity.

A Genetic Engineering Approval Committee (GEAC) official says that the committee had not been sent an official complaint of contamination yet to warrant investigation. Mahyco, on the other hand, insists the trial field was "burnt on August 15" and the required 200 metre isolation maintained. There is no evidence, it added, to back the claim that the samples were sourced from spots anywhere outside the trial location. However Gene Campaign says that the GM crops were not burnt and the stalks remained.

Critics of GM technology in the country have repeatedly questioned the strength of our regulatory mechanism. Supreme Court-appointed GEAC special invitee P.M. Bhargava feels that "for all practical purposes there is none at all". "First of all, only 10 per cent of the tests that ought to be done are done. And even those 10 per cent are done either by the company (seeking to promote the genetically engineered substance) or on samples provided by the company," he says.

If GM contamination is detected in India, it will impact the country’s rice exports to Japan and the west, especially Japan and the EU, where governments are cautious on GM technology, given the widespread uneasiness their citizens have for GM crops and food. India, the second-largest rice producer in the world, exports more than four million tonnes of rice a year.

R.S. Seshadri, member of the All-India Rice Exporters Association and director of Tilda Ricelands, says the government needs to step in immediately to establish for sure if contamination has occurred. He says, "If yes, the law must be taken to its logical conclusion and the safeguards further tightened. If the government doesn't do it quickly enough, it will then need a clean-up operation like in the US, which had to spend millions of dollars after genetic contamination in rice was detected in 2006."
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2.Farmers and experts called for moratorium on GM crops
Economic Times (ET), 24 Jan 2009
http://economictimes.indiatimes.com/Markets/Commodities/Farmers_and_experts_called_for_moratorium_on_GM_crops/articleshow/4024347.cms
 
NEW DELHI: Farmers and experts have called for a moratorium on genetically modified (GM) crops in the country in view of established related health 
and environmental hazards. Charging the key regulatory body of "compromising" its fundamental brief of securing public health and safety in the context of GM crops, they have called for a stop on the introduction of both GM Brinjal and GM rice.

Criticizing the lack of appropriate regulations and the haste to release GM crops in the environment, the founder-director of the Hyderabad-based Centre for Cellular and Molecular Biology and the Supreme Court's nominee in the Genetic Engineering Approval Committee GEAC), Dr Pushpa M Bhargava told presspersons here that the GEAC was not sufficiently enabled to oversee/regulate approvals and ensure health and environmental safety.

Dr Bhargava charged the GEAC has allowed field trials and release of GMOs without any proper biosafety measures. Noted farmer leader and the President of Bharatiya Krishak Samaj, Dr Krishan Bir Chaudhary, also at the meeting, alleged that the government has allowed and encouraged the seed companies and multinationals like Monsanto to take over seeds, thus negating the farmers' sovereign rights over seeds. Such a situation would lead to food security problem and endanger the livelihood of farmers, he said.

He said that farmers have suffered heavy losses due to failure of Bt cotton in many parts of the country. The incidence of mealy bug and other pests on Bt cotton had exploded the hollow claims of GM technology, he maintained, adding that Bt cotton has resulted in low yields and led to largescale sheep mortality in cotton fields. The incidence of sheep mortality had shown that any food crop containing Bt gene can cause health hazards, he said, urging the government to stop release of Bt brinjal. Introduction of Bt rice would damage country's export prospects, particularly that of Basmati rice he said.

Jeffrey Smith, author of the best selling "Genetic Roulette and Seeds of Deception" supported Dr P M Bhargava's contention that regulatory oversight has been compromised. He added that even Food and Drug Administration [FDA] in the USA is also responsible for lack of oversight.

Both Dr Bhargava and Dr Chaudhury charged that there was a dangerous nexus between regulatory authorities, bureaucrats, politicians and multinational corporations which can utterly compromise the health of Indian people.
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3.'State should lead the fight against GM food'
Express News Service, 21 Jan 2009
http://tinyurl.com/bpzkrj

ISTTHIRUVANANTHAPURAM: "India should be declared a GM-free country,’’ said Agriculture Minister Mullakkara Ratnakaran here today. He was inaugurating the workshop on ‘Impact of Genetically Modified (GM) Food and Crops on health and biodiversity’ organised by the Kerala State Biodiversity Board.

The Minister said that Kerala had already been declared a GM-free State and we should lead the fight in defending the country against GM foods. ‘’We should abide by nature and defend ourselves from being laboratories of genetically-modified foods,’’ he said.

"The experiments on the consequences of consuming genetically-modified foods are still in the cradle and we don’t have to mortgage our freedom to decide our food to Monsanto or any other multinational company. We don’t want them to take away our right to decide our food or the pesticide to be used in our fields,’’ the Minister said. ‘’The corporates make GM food not in the interest of the humanity, but to further their business interests,’’ he added.

A book titled ‘Genetic Roulette’ by Jeffrey M.Smith was released by Ratnakaran on the occasion by giving a copy to V.S.Vijayan, chairman of Kerala State Biodiversity Board. Jeffrey is the executive director of the Institute for Responsible Technology, USA.

Jeffrey, in his lecture, said that any flexibility shown by the Government in the matter of GM food would be dangerous. ‘’Allowing it will be an irreversible decision. Genes that we introduce would cross-pollinate, self-propagate and the outcome can be much more overwhelming than the global warming phenomenon,’’ he said.  The unpredictable changes that a genetically-modified food can cause is the transfer of gene from food to our body cells or the bacteria that live inside us. The GM protein produced by the gene may have effects that were not intended, including toxic ones. Similar effects may also be caused if the inserted genes change its order.

"Worldwide, we should be campaigning for an immediate moratorium on GM trials. The Governments are not even conducting any clinical trials for GM foods or safety evaluation studies,’’ said Jeffrey, while listing the toxic effects of GM cotton, GM corn, GM soy, GM potato and GM tomato across the world. The GM products could introduce new allergens, toxins, disruptive chemicals, soil-polluting ingredients, mutated species, and unknown protein combinations into our bodies and into the whole environment,he said. "Here in India, labourers in cotton field have reported allergic reactions such as itching, skin eruption and discolouration after picking cotton. The cattle which fed on the plants after harvest also had severe problems like frothy salivation, nasal discharge, bulging head, fever and death. Buffaloes in Warangal that fed on GM crops had reproductory problems, abortions, reduction in milk yield and skin problems,’’ said Jeffrey.

Jeffrey said that researches across the world had shown that genetically-modified food can cause liver problems, reproductive problems, sterility, infant mortality, diseases and death in mice. "There is also a possibility that the toxin can affect the bacteria inside the rumen of the animals as post-mortem results showed that a lot of undigested GM cotton was found inside the rumen of buffaloes,’’ he said.
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4.Bayer threatens affordable drugs in India
Press Release, January 27, 2009
Health Action International Asia Pacific (HAIAP) 
Peoples Health Movement - India
Coalition against Bayer Dangers (Germany)
Health groups: Defend affordable drug treatment in India

Bayer sues Indian Government to retain monopoly rights / International coalition demands protection of generic pharmaceuticals

Health groups call on German drugmaker Bayer to cancel the suit against the Indian government and domestic drug company Cipla in order to protect affordable drug treatment. The organizations fear that the fate of generics in India may hinge on this case and that thousands of Indians will die without affordable pharmaceuticals.

Last year Bayer sued the Indian government in the Delhi High Court for giving marketing approval to Cipla for Bayer's patented cancer drug Sorafenib. At present, the Indian drug regulator DCGI can give a marketing approval to a generic drug even if the medicine is patented in India. Public health experts point out that marketing approval for a drug is not an infringement of a patent, and the generic company can be challenged once it launches the drug.

Amit Sen Gupta from the Indian Peoples Health Movement says: “The Bayer case has implications for drug access, not just for patients in India, but for poor people in large parts of the world. It would mean giving sanctity to higher standards of patent protection than what is required even by the TRIPS agreement. Bayer not only seeks to safeguard its own monopoly right, the company also wants to set a precedent that other corporations can benefit from. In essence it would mean that the entry of generic versions of life saving drugs would be delayed.”

Philipp Mimkes from the Coalition against Bayer Dangers, an international network based in Germany, adds: “The interest of patients is at risk if marketing approvals are linked with patents. Countries like India must have the possibility to issue compulsory licenses to generic companies or to impose price controls in order to make available affordable drugs. We demand that Bayer quits this suit! Safeguarding public health must take precedence over patents and monopoly profits of drug companies!”

The case seeks to link the patent status of a drug with the procedures related to the drug’s marketing approval. Across the globe, such linkage is the exception rather than the rule. That is so because the body responsible for granting patent applications is distinct from the one that grants approval for marketing. To ask drug regulators to do the job of the Patent office is incorrect because they don´t have the expertise to decide on patent related issues.

The Indian law has a provision for post-grant opposition, i.e. the grant of a patent can be challenged on several grounds after it is granted. A blanket bar on granting marketing approval to drugs which have been granted patents would mean that this provision becomes ineffective the generic company would not be able to make use of this provision immediately even if a patent grant is overturned.

Moreover, both the TRIPS agreement and the Indian law allow medicines to be legally registered even when the drug is under patent protection. It can be allowed so that the generic version of the medicine can be made immediately available as soon as the patent term of a medicine expires or as soon as a compulsory license is issued to a generic company. It can also be allowed in situations where the medicine is used for research purposes. This provision is an important health safeguard because it allows generic manufacturers to conduct tests on its generic version, so that it is ready for marketing as soon as it is legally possible. In the case of life saving drugs, even a delay of a few months in the introduction of cheaper generics can mean hundreds or thousands of deaths among patients who would die, not because there is no treatment, but because the treatment with a patented medicine is too expensive.

If Bayer's plea is upheld, it would be in violation of the Indian Patent Act. This would be extremely unfortunate, as it would mean overturning some of the health safeguards that the Indian Parliament had put in place when the Indian Act was amended in 2005 to make it TRIPS compliant. It may be recalled that the Indian Parliament, while putting in place these safeguards had taken into account the very large mobilisation of people in India as well as across the globe - demanding that India continue to function as a source for affordable generic medicines. 

See also The Times of India: “Fate of generics hinges on Bayer case” http://timesofindia.indiatimes.com/Fate_of_generics_hinges_on_Bayer_case/rssarticleshow/3998349.cms

contact:

*      Dr K Balasubramaniam, HAI Asia Pacific, Tel: +94 112 554353, This email address is being protected from spambots. You need JavaScript enabled to view it., www.haiap.org

*      Amit Sen Gupta, Peoples Health Movement India, This email address is being protected from spambots. You need JavaScript enabled to view it., http://phm-india.org

*      Philipp Mimkes, Coalition against Bayer Dangers, This email address is being protected from spambots. You need JavaScript enabled to view it., www.cbgnetwork.org