The Review Committee on Genetic Manipulation (RCGM) housed in the Department of Biotechnology (DBT) recently released draft guidelines for the regulation of genetically edited organisms (plants, animals and humans) in India for public consultation. More than 90 responses were submitted in response. After curation, RCGM invited select responders, including Takshashila Institution’s Shambhavi Naik, to a stakeholder discussion at DBT.
The draft guidelines are a good starting point for regulating genetically edited organisms, but Shambhavi pointed to three areas of improvement in the draft:
a) Inclusion of benefits of applications and subsequent consideration of applications based on a benefit:risk ratio: The current draft assesses applications only on risk. Such an approach will deter the fast-tracking of approaches beneficial to India. Instead a benefit:risk assessment would help prioritise applications for quick approvals as well as public funding.
b) Consideration of ethical risks of the applications: The draft guidelines do not consider ethical issues in their risk assessment. Consequently it is unclear who will make the decisions on the ethical acceptability of applications.
c) Parallel processes for startups: The procedure set up in the draft guidelines for getting approval for using gene editing technologies is cumbersome and not conducive to startup growth. An alternate process for facilitating start ups to gain approval was suggested.
A revised draft guideline is expected within a few weeks time.