US FDA issues warning letter to Telangana animal testing lab for 'serious violations'

Hyderabad: The US Food and Drug Administration (FDA) has issued a warning letter to Palamur Biosciences Private Limited (PBS), a Telangana-based beagle breeder and animal testing lab, citing serious violations of regulations.

FDA investigators from the Office of Bioresearch Monitoring Inspectorate (OBMI) Foreign Inspection Cadre inspected the facility from January 20 to 27, 2025.

The visit followed a People for the Ethical Treatment of Animals (PETA) India whistleblower exposé revealing alleged abuse of dogs, rhesus macaques, and minipigs. The lab, which conducts drug, pesticide, and medical device tests often for foreign clients faces accusations of breaching animal welfare protocols.

Although issued last week in December, the public warning surfaced recently after PETA urged the Prime Minister's Office (PMO) to act. PETA highlighted serious violations of Good Laboratory Practice (GLP) regulations and systemic oversight failures that undermine the quality and integrity of safety data generated at the facility.

In its letter to the PMO, PETA noted that US FDA's findings echo animal welfare concerns it raised seven months ago. These align with a detailed inspection report submitted to the Committee for the Control and Supervision of Experiments on Animals (CCSEA) on June 17, 2025, by a government-appointed multidisciplinary committee yet to prompt action. Palamur Biosciences houses over 1,200 animals, including beagles, monkeys, cows, pigs, and other species, used for experiments or, in the case of dogs, bred and sold to other labs.

PETA has also written to the Union Minister of Fisheries, Animal Husbandry and Dairying, urging immediate intervention. It called for addressing not only Palamur's entrenched non-compliance but also the compromised functioning of the CCSEA a statutory regulator whose Core Committee largely comprises animal experimenters, despite its mandate to prevent unnecessary pain or suffering.

The FDA warning follows the January 2025 inspection and review of Palamur's inadequate written responses. The agency concluded that the facility committed "serious violations of Title 21, Code of Federal Regulations (CFR) Part 58," stemming from systemic failures in study director oversight that question the reliability of safety data.

PETA cited FDA's letter that key deficiencies included poor or absent veterinary records; lack of documented health exams before invasive procedures; inhumane euthanasia methods; unsanitary conditions with animal droppings and pest harborage; unapproved protocol deviations; and failures by the Quality Assurance Unit to detect issues. The FDA deemed Palamur's explanations insufficient, warning that unreliable data could endanger public health and safety.

"Another major international regulator has now confirmed, in unmistakable terms, what whistleblowers and government inspectors in India have documented: the animal welfare and other failures at Palamur Biosciences are systemic, entrenched, and dangerous," said Dr. Anjana Aggarwal, Scientist and Research Policy Advisor at PETA India.