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.

 

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