Naveed Uddin Khan Uzair
Palamur Biosciences Private Ltd (PBPL), a pre-clinical contract research organisation (CRO), has come in for scrutiny involving its lab animal practices, with animal welfare representatives alleging violations of the Prevention of Cruelty to Animals (PCA 1960) Act – something the company has refuted.
In a recent letter to the Union Minister of Fisheries, Animal Husbandry and Dairying – the head of Humane World For Animals India Foundation (HWFAIF) Alokparna Sengupta expressed concern over the delay in acting on a report that listed alleged violations of the PCA Act, following an inspection earlier this month at the company’s facility. In her capacity as one of the inspectors of the multi-disciplinary team that visited the facility, Sengupta wrote, “a week since submission of the (inspection) report, and a meeting of the Committee, there appears to be no indication of action under Section 19 of the Act or Rule 14 of the 1998 Rules.” The report had called for urgent “removal and rehabilitation of the animals to prevent further pain, distress or suffering.”
The inspection team included members from the apex ministry’s Committee for the Purpose of Control And Supervision of Experiments on Animals (CCSEA), the Animal Welfare Board of India and the Institutional Animal Ethics Committee, besides HWFAIF. “A comprehensive report, documenting egregious animal welfare concerns and multiple serious lapses in legal compliance at Palamur, was submitted to the Committee 17.6.2025,” the letter said.
Sengupta told businessline, CROs should adhere to CCSEA protocols when undertaking such studies. CROs undertake research for academic institutions and pharmaceutical companies, and regulatory agencies including the United States Food and Drug Administration have been putting a fine point on data integrity and the quality of management procedures from CROs. The letter, also addressed to Secretary – Department of Animal Husbandry and Dairying, besides Chairperson -CCSEA – called for “suspension and review of PBPL’s registration and breeding licence and direct seizure and rehabilitation of animals in their custody, to prevent further unnecessary suffering.”
PBPL refuted the allegations, calling it “baseless and misleading.” In an emailed response to the correspondent, PBPL’s Dr Ramamoorthy said, “a micro-audit by CCSEA will be conducted at our facility on 28th and 29th of June 2025….Once the official report is finalized, we will make it available to the public. We are confident that the findings will reaffirm our commitment to ethical research and compliance.”
Whistle-blower complaint
The alleged violations were earlier flagged by a whistle-blower-led complaint by People for the Ethical Treatment of Animals (PETA India), on apparent violations of GLP (Good Laboratory Practices) norms, and the Drugs and Cosmetics Rules, 1945, among other things – according to separate letters from Dr Anjana Aggarwal, Peta India’s Scientist and Research Policy Advisor, to the Union Minister of Fisheries, Animal Husbandry and Dairying; the Drug Controller General of India; and the National GLP Compliance Monitoring Authority.
She said, the inspection report detailed “extensive and serious violations of CCSEA guidelines”, “including poor-record keeping, improper euthanasia methods, a lack of pain-relief even during invasive procedures, ….more than the number of approved animals…” Over 1,200 animals are kept poorly, she alleged.
GLP certified
The Hyderabad-based CRO, countered, it was GLP- certified and CPCSEA-registered outfit, complying with global regulatory standards. PBPL operated “India’s only large animal research facility, capable of conducting validated, regulated studies using …Beagle dogs, farm pigs, miniature pigs, and non-human primates,” Ramamoorthy said, and they had Southeast Asia’s most advanced medical device testing facility, crucial for the evaluation of life-saving medical technologies.” He also shared a CCSEA public notice, asking establishments to “disregard” communication from Peta India. “The CCSEA remains committed to addressing violations within its jurisdiction and will ensure that appropriate actions are executed in compliance with the applicable laws and guidelines,” the notice said.
Published on June 29, 2025
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