Pest Management Regulatory Agency not accepting pesticide registration data from non-compliant laboratory
This information is no longer up-to-date and the Pest Management Regulatory Agency is now accepting data from Palamur generated after 1 October 2024.
13 June 2024
Health Canada’s Pest Management Regulatory Agency (PMRA) is not accepting studies generated by Palamur Biosciences Lab (Palamur) in Telangana, India, due to the possible falsification of data following an inspection by the Indian National Good Laboratory Practice Compliance Monitoring Authority (NGCMA). Applicants and registrants should not submit any new data from this lab until further notified by PMRA.
In July 2023, NGCMA conducted an inspection of Palamur and audited 58 product chemistry and acute toxicity studies conducted between January 2020 and July 2023. The audit found that data were falsified for most of those 58 studies and NGCMA issued a ‘Not in Compliance’ status for the laboratory. These results of this Good Laboratory Practice (GLP) audit were subsequently communicated more broadly via the Organization for Economic Co-operation and Development’s GLP workgroup and Mutual Acceptance of Data Program.
Currently, PMRA is not accepting any data generated by Palamur and advises applicants and registrants not to submit any new data from this laboratory. PMRA has identified two pending registration applications and two currently registered end-use products that rely on Palamur-generated product chemistry or acute toxicity data. PMRA has contacted these registrants and informed them that they will need to replace the Palamur-conducted studies in order to meet the relevant data requirement(s) for registration. PMRA will work with each affected registrant to obtain appropriate replacement data or take other appropriate action, which may include cancellation.
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