FOCUS ON ASIA

Yesterday we noted how as part of the biotech industry's campaign to weaken India's Genetic Engineering Approval Committee and fast track approval of GMOs, the Federation of Indian Chambers of Commerce and Industry (FICCI), in concert with others in the biotech lobby, was planning a big GM promotional as part of 'deliberations' on reforming India's regulatory system India - an 'International Conference on Agricultural Biotechnology' entitled 'Ushering in the Second Green Revolution'.

The second item below gives an example on how FICCI is after "curtailing Genetic Engineering Approval Committee's (GEAC) powers by seeking changes in rules relating to production and handling of micro-organisms, cells and genetically modified organisms (GMOs)." (Biotech Sector Wants GEAC Wings Clipped)

The first item reflects the biotech lobby's concern over what they see as stagnation in the GM crop sector in India. Shantu Shantaram spells it out very clearly with his complaint in the article that, "all we have is one stupid Bt cotton to talk about." India's prominence within the developing world makes what they perceive as a slow introduction of GM crops there all the more frustrating for the biotech lobby.

The article introduces Shantaram simply as "Dr Shantu Shantaram, Biologistics International USA". This is understandable as this is how Dr Shantaram likes to present himself. What this self-presentation omits, however, is that Shantaram is an employee of GM giant Syngenta.

At Syngenta, Shantaram developed the corporation's PR strategies for biotech projects, including Golden Rice. Prior to Syngenta, he was employed by the US Department of Agriculture. Biologistics International is Shantaram's 'consulting firm' on biosafety. No doubt Dr Shantaram will be putting that expertise to good use to help India usher in its 'Second Green Revolution'.

Much of the drive to reform India's regulatory system has its roots in a forum on regulatory development set up by Syngenta, in which MS Swaminathan took a prominent part. It was Syngenta's forum which established many of the principles behind the proposals for regulatory reform now being brought forward.

The aim seems clear: to weaken India's regulatory system and then use it as a blueprint to sell to other Asian countries - very much in the manner ijn which South Africa's fast-track system is now being promoted as a model throughout Africa.

1.Agri-biotech stuck in groove: expert
2.Biotech Sector Wants GEAC Wings Clipped
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1.Agri-biotech stuck in groove: expert
Financial Express, July 19, 2004
http://www.financialexpress.com/fe_full_story.php?content_id=63899

Is the agri-biotech industry in India stuck in the same place or is it moving forward?

"I have been watching the biotech in agriculture scene since 1985 and lately, it seems to me it is stuck. We are not making any progress," noted Dr Shantu Shantaram, Biologistics International USA. He placed partial blame for this on the lack of knowledge about the subject, which in turn came from a lack of communication from the stakeholders. According to him the entire genetically modified foods debate was a "collosal failure of communication."

Common people have been fed unscientific information on biotechnology and this has led to a fear and therefore outright rejection of biotech - at least as far as food is concerned, he pointed out. While there is a lot of excitement over pharma biotech - (which is more attractive even from the investment point of view) - when it comes to agri biotech, "all we have is one stupid Bt cotton to talk about," Dr Shantaram complained.

This is at a time when scientists like Dr Gurudev S Khush, known for his pioneering work on rice which revolutionised rice cultivation, are talking of biotech as an 'imperative'. The Dr Khush warned that the world's current production of 2.16 billion tonnes of foodgrain will need to reach 3.11 billion tonnes by 2025. Moreover the challenge would be to achieve this with even more scarce resources less water, less land (which is being taken away by buildings), less labour and less chemicals than now. The only way to increase yield, and the quantity and quality of food produced is through biotechnology, he stressed. Quoting the Nuffield report on Bioethics he said "(we) do not see any other route unless we destroy our forests." While the scientific world was working on vitamin A enriched rice, as well as strains of crops that could withstand abiotic stresses such as salinity, drought conditions, floods and so on, there was still the matter of convincing the public of the need for biotechnology.

Communication of this was important and the "media needs to report science accurately," he said. Protests across the world were slowing down growth of biotechnology, again a function of communication, or miscommunication. Quoting a 2003-04 FAO report he said that the FAO "urges the poor countries to realise the potential of biotech. Developed countries, especially Europe need to realise that their opposition is harming the developing world.'' But a 'propaganda of fear' had been built around biotech. "Leave alone the common man, even politicians, and the media are very confused about agri biotech," Dr Shantaram said. The problem was that the anti biotech lobby was stronger; they went out to "camp among people and tell them" while "we scientists are just convincing each other," he said. This has also led to regulations for agri biotech being more stringent than that for pharma biotechnology.

Despite the 'overwhelming evidence' of safety, governments still shy away from biotechnology. Public sector investment in the area is also low. Investment today will see returns only 15 years and the delay of each day is pushing that date further, warned Dr Shantaram.

© 2004 Indian Express Newspapers (Bombay) Ltd.
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2.Biotech Sector Wants GEAC Wings Clipped
The Financial Express, India
by Ashok B. Sharma
http://www.financialexpress.com/fe_full_story.php?content_id=63660
16 Jul 2004

NEW DELHI: The biotech industry has favoured curtailing Genetic Engineering Approval Committee's (GEAC) powers by seeking changes in rules relating to production and handling of micro-organisms, cells and genetically modified organisms (GMOs).

They have alleged that the 'rules for manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells, 1989' (EPA-Rules 1989), framed under the Environment Protection Act, 1986, have given unnecessary powers to GEAC to intervene, which is hindering the growth of the biotech industry.

Apart from the rules being "protectionist in nature," it prima facia "wrongly" reflects that any micro-organism, whether naturally occuring or genetically modified, is risky and hazardous. The industry has suggested that EPA-Rules 1989 can be amended by a government notification instead of seeking ratification by the Parliament.

In a memorandum to the union environment ministry and the RA Mashelkar panel on recombinant pharma sector, the biotech division of the Federation of Indian Chambers of Commerce and Industry (Ficci) has suggested that micro-organisms listed in risk category-1 under EPA-Rules 1989 should be exempted from regulations. Biosafety and risk assessments of micro-organisms, GMOs and biologicals should be done as per guidelines issued by WHO and US Food and Drug Agency (FDA).

All drugs, whether recombinant or not, should be treated under Indian Pharmacopia.

Calling for a change in the approval regime for imports of micro-organisms and GMOs, the memorandum suggested that academic institutions and the biotech industry should be permitted to import less risk organisms with the approval of their in-house institutional biosafety committee (IBSC) and after intimation to the union environment ministry, department of biotechnology (DBT), Indian Council of Medical Research (ICMR) and Indian Council of Agricultural Research (ICAR). It also said that the import licence should be given by the Drugs Controller General of India (DCGI). However, high-risk organisms should be imported with a short approval process by the enivornment ministry and not by the GEAC.

The research and development (R&D) labs approved by the Council for Scientific and Industrial Research (CSIR), should be allowed to import biologicals with the approval of their in-house bioethics committee and through a system of self-regulation. There should be a common approval for export, import and transportation of GMOs.

Ficci’s biotech division has alleged that GEAC is not the competent authority for assessing clinical trials involving both humans and animal studies. It says that the approval for clinical trials should be given by DCGI, while GEAC can only fix specific timeframes for inspections and approvals. In case of new applicants seeking approval for the already approved products, the process of approval should be simplified.

The memorandum also said that the use of products derived from GMOs and micro-organisms should be exempted from regulations, while the GMOs used as a product may be covered under the regulations. Instead of case by case approval, a positive list of GM ingredients for foods should be evolved, based on scientific method with discussions with stakeholders.

The grant of approvals under rules 8 to 11 under the existing EPA-Rules 1989 should be extended for a period of 7 to 10 years, in lieu of the existing 2 year period.

The memorandum said that the definition of micro-organism should be made consistent with that adopted under Drugs and Cosmetics Act, Indian Patents Act and the Plant Quarantine (Regulation of Import into India) Order, 2004. Micro-organism cultures used as references while testing food or samples for environment safety in labs should not be covered under regulations.

The memorandum also called for intellectual property protection, simple benefit sharing model for use of community-owned bioresources, standardisation of protocols, simple mechanism for transfer of agricultural biotechnology from public sector R&D institutes to the industry, and acceptance of credible regulatory data from US and other countries on biomedical research.

It said that the industry should not be made accountable for its financial disclosures to the GEAC, and there should be clarity in "what consitutes a violation of the rule and nature of penalties."

The Rules-1989 should also unveil the details of the Appellate Authority.