Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report

Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturer. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.

POOJARY Brinda;  VIVIANI Laura;  SENGUPTA Alokparna;  KALAIVANI M;  VERMA Rajeshwar;  TENG Vijay;  MAKHIJA Vijay;  PRAKASH Ram;  BHATIA Nitin;  SINGH S N;  BRUCKNER Lukas;  HALDER Maria Elisabeth;  VREE Jeroen; 

2023-06-14

ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD

JRC129864

1045-1056 (online),   

https://www.sciencedirect.com/science/article/pii/S1045105623000039,    https://publications.jrc.ec.europa.eu/repository/handle/JRC129864,   

10.1016/j.biologicals.2023.101665 (online),