On 13 November 2024, the U.S. Environmental Protection Agency (EPA) announced the resumption of accepting pesticide registration studies from Palamur Biosciences Pvt. Ltd., Telangana, India. This decision comes after Palamur implemented stringent internal controls and regained Good Laboratory Practice (GLP) certification.
Background: Why the Ban Was Enforced
In May 2024, the EPA suspended the acceptance of studies from Palamur due to confirmed falsification of data in 58 studies conducted between January 2020 and July 2023. The suspension followed an investigation by India’s National Good Laboratory Practice Compliance Monitoring Authority (NGCMA), which issued a ‘Not in Compliance’ status for these studies.
Steps Taken to Regain EPA’s Trust
Palamur’s reinstatement is based on a comprehensive overhaul of its practices, including:
- Implementation of third-party audits.
- Establishment of a whistleblower policy.
- Regular internal audits and inspections.
- Formation of an ethics oversight committee.
Additionally, all study directors involved in the falsified studies have been removed from the organisation.
Scope of Reinstatement
The EPA will now accept:
- Studies initiated on or after 1 October 2024.
- Large animal studies initiated after 27 July 2023, provided they concluded on or after 1 October 2024.
Data from studies conducted between January 2020 and September 2024 remain inadmissible. All accepted studies will undergo stringent review by the EPA’s Office of Pesticide Programs to ensure compliance with GLP standards.
Palamur’s renewed compliance, supported by its updated OECD GLP certification, underscores the EPA’s commitment to ensuring data integrity in pesticide safety evaluations.
