Takshashila Policy Advisory – Comments on the National Guidelines for Gene Therapy Product Development and Clinical Trials

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This policy advisory contains recommendations and comments in response to the draft National Guidelines for Gene Therapy Product Development and Clinical Trials released by the Indian Council of Medical Research (ICMR) in consultation with the Department of Biotechnology (DBT) and Central Drug Standards Control Organisation (CDSCO) in July 2019.

We note that some aspects of the guidelines require further conversation. Our comments to the guidelines focus on four distinct areas, with the following recommendations.

Applicability of the Guidelines. We recommend that the definition of “therapy” and “disease” be expressly stated. The guidelines should also clarify whether they are applicable to genetic enhancement therapies. We recommend that the guidelines not ban germline gene editing applications. Instead, they should specify standards that could be used to assess the acceptability of germline gene editing.

The Guiding Principles. We recommend a revision of the guiding principles and inclusion of the following tenets:

  • Scientific research must not be unnecessarily inhibited by regulations.
  • Regulation is better than outright prohibition.
  • A technology and its applications must be viewed separately.
  • Global and national interests must be balanced.
  • Policymaking must be scientific and inclusive.

Implementation challenges for the Guidelines. We recommend that instead of forming another committee in addition to the existing RCGM and CDSCO to approve applications, the proposed Gene Therapy Advisory and Evaluation Committee (GTAEC) be tasked with laying out guidelines for individual diseases. In addition, we suggest that some of its functions be outsourced to independent accreditors approved by, and responsible to, the GTAEC. These accreditors can provide certificates of clearance to institutions after following the protocols laid down by the GTAEC.

Capacity Building for gene editing research and translation. We recommend that grants to laboratories include costs for raising awareness about gene editing. Further, the guidelines should also include a section on patient counselling and capacity building around services for gene editing advocacy and outreach.


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