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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) July 2004 by Ashok B Sharma
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
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
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
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.?
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