General Guidelines regarding the Registration of EDVs under Section 23 of PPV&FR Act, 2001 read with Rule 35 of PPV&FR Rules, 2003
The PPV&FR Authority in its 23rd Authority Meeting has approved the following guidelines for registration of EDVs and the same are provided hereunder:-
- Candidate varieties of EDVs would need to be tested for one year at two locations for the group of traits not affected by the trait of derivation that is, insect resistance under protected and natural conditions along with their respective IVs.
- For EDV of which IV is in public domain, the variety being considered for registration shall be IV for another variety derived from that variety. Application and prior registration of an IV is a pre-requisite for any variety to be considered of its EDV or otherwise it can be considered as a new/extant variety normally.
The application should contain following-
- Confirmation of the Event and gene protein expression data.
- No objection Certificate (NOC) for using the event from the concerned Technology Provider.
- The comparative data on bio efficacy, agronomic and pest infestation (both under protected and unprotected environments if the transgene imparts resistance to diseases/pest resistance) along with the respective IV as a comparator, generated preferably by the public sector.
- Comparative photographs of IV and EDV on the same scale and stage showing distinctness between IV and EDV. However, when the derived trait causes an effect that may cascade into major differences between the IV and EDV under natural conditions where the derived trait is expressing, photographs to ascertain their similarity in other traits need to be provided under controlled conditions such that the derived trait expression is not apparent between IV and EDV (in a trial for a trait that is stress resistance related, the trial should be protected from the concerned stress to establish the similarity between IV and EDV as in the case of a disease, pest, abiotic stress resistant EDV derived from a susceptible IV).
- An affidavit from the applicant that the data submitted by the applicant are correct and reliable.
- GEAC permission for commercial release of the hybrid/variety.
- Comparative statement of EDV and IV as per DUS test specific guidelines (under protected and unprotected environments if transgene impart disease/pest resistance).