Plant Transformation

Regulatory Sciences

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Services > Regulatory Sciences

Plant biotechnology research and business in India is regulated by the Government of India through various Government committees and departments. The experiments, depending on the extent of exposure to the environment require various degrees of approvals from these committees. Currently a three tier regulatory system is in place in India which consists of the following committees

Institutional Bio-Safety Committee (IBSC) for experiments conducted within approved laboratories and contained greenhouses.



Regulatory Sciences
Review Committee for Genetic Manipulation (RCGM) for experiments involving import of transgenic material (tissue, DNA, seeds, any other plant parts), limited field trials, biosafety and toxicity studies.

Genetic Engineering Approval Committee (GEAC) for large scale field trials, commercial approval for transgenic crops.

Metahelix has strong experience in conducting regulated and approved plant biotechnology related projects for various customers. All these approvals require a detailed understanding of the applicable regulatory regime, calling for timely meetings of the IBSC, approvals from RCGM and GEAC as the case may be.

Metahelix provides the following types of services
   
Import and Export of Biological materials.
Molecular analysis of transgenic plants
 
  Southern Analysis for gene integration and molecular characterization of event
  Northern Analysis and Western Analysis
Gene Efficacy
 
  Insect Bioassays
  Expression Levels,
  Limited field trials for transgenic plants
Event Specific PCRs for transgenic events
 
  Zygosity testing for transgenic events
  Tests for transgenic contamination with a Limit of Detection (LOD) of 0.01% in most crops.

Metahelix has an experienced regulatory science team that will co-ordinate with various Government agencies and departments to obtain approvals for the entire project and will execute the project at its facilities/research site as required by the customer. For more information please contact regulatory@meta-helix.com

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