Coalition’s Comments on draft “Genome Edited Organisms: Regulatory Framework & Guidelines for Risk Assessment”

From: GM Free India <>
Date: Fri, 21 Feb 2020 at 09:22
Subject: Comments on draft “Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment”
To: <>, <>
Cc: <>, <>, <>, <>, <>, <>, <>


Chairperson/Member Secretary,

Review Committee on Genetic Manipulation (RCGM),

RCGM Secretariat,

Department of Biotechnology,

Ministry of Science and Technology

Block 2, CGO Complex, Lodhi Road,
New Delhi – 110003


Dear Sir/Madam,

Sub: Submission of comments on draft document on Genome Edited Organisms: Regulatory Framework and Guidelines for Risk Assessment

Greetings! This is to respond to your “Draft document on Genome EditedOrganisms: Regulatory Framework and Guidelines for Risk Assessment”.

We had in the past written to the Genetic Engineering Appraisal Committee at least twice (here and here) asking for genome editing to be regulated in India, and it is indeed high time that India finalised regulatory norms and guidelines for the same before un-regulated experiments are undertaken by various entities. We however do not understand why the same department which promotes and funds biotechnology projects in India, is also playing the role of regulation or drafting of this regulatory framework.  The job of drafting regulatory framework and guidelines for risk assessment as well as executing the same should rest with a body which does not have any conflict of interest.

The key points we would like to make with regard to the draft framework are the following:

  • Genome Edited products are not the same as chemical or radiation-induced mutagenesis or conventional breeding products, and regulatory approaches must not go with such comparative assumptions and go wrong in regulation itself;
  • Categorisation of genome-edited products by risk categorization of the end product is a wrong approach. It is contradictory to the legal definition of Genetic Engineering and Gene Technology as given in the EPA 1989 Rules and also defies scientific knowledge about process-related risks;
  • Enforcing compliance is not an issue as S&T around genome editing is evolving rapidly and therefore, the bar of regulation cannot be pegged lower than it ought to be, compromising on the very objective of regulation, which is to protect human health and environment from biosafety-related risks of modern biotechnology;
  • We believe that unless serious shortcomings in the current regulatory regime are addressed urgently, the fate of regulation of gene-edited organisms and products will also be in the same pathetic state as other genetic engineering techniques, and this would be unacceptable.

Whilst we are providing an initial response to the draft regulatory framework with a summary here and a point-by-point response in the attached document, we demand an additional 3 months for a full response given the scope of the document and its potential ramifications, and to enable more citizens and citizens’ groups to participate in this consultation process.


Coalition for a GM-Free India


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