The U.S. Environmental Protection Agency (EPA) announced on November 13, 2024, that it will resume accepting studies for pesticide registration from Palamur Biosciences Pvt. Ltd., a Telangana, India-based lab. This decision applies to studies initiated on or after October 1, 2024, following the EPA’s verification of enhanced internal controls implemented by Palamur.

Background

In 2023, the EPA identified data falsification in studies from Palamur. An audit conducted by the Indian National GLP Compliance Monitoring Authority (NGCMA) confirmed non-compliance for 58 studies conducted between January 2020 and July 2023, prompting the EPA to halt data acceptance.

Palamur’s Corrective Measures

To address these issues, Palamur introduced:

• Third-party audits
• Whistleblower policies
• Regular internal inspections
• An ethics oversight committee

The lab also replaced implicated staff and renewed its OECD GLP certification, leading to the EPA’s reacceptance of data.

EPA’s New Guidelines

EPA will now review:

• Studies initiated on or after October 1, 2024
• Specific large-animal studies initiated after July 27, 2023, and completed on or after October 1, 2024

Studies conducted between January 1, 2020, and September 30, 2024, remain ineligible.

How REACH24H Can Help

Navigating complex regulatory landscapes like EPA pesticide registration is challenging. REACH24H offers:

• Expert guidance on EPA and global pesticide regulations
• Support in preparing GLP-compliant studies
• Strategies to ensure data acceptance and streamline submissions

Why Trust REACH24H?

• Proven Expertise: Decades of experience in regulatory compliance and pesticide registration.
• Global Reach: A strong network to navigate regional and international regulations effectively.
• Client-Focused Solutions: Tailored services to meet the unique needs of our clients.