Question : National Institute of Animal Health (NIAH)

(a) whether the Government has established the National Institute of Animal Health (NIAH) as a national facility for quality assessment of veterinary vaccines and diagnostics to be used in India;
(b) if so, the details thereof along with the progress made since its inception ;
(c) whether the NIAH has successfully created the central database of veterinary biological to form a repository of all veterinary vaccines being produced or imported and used in India;
(d) if so, the details thereof;
(e) whether the NIAH has developed a network of expert labs for testing as a large number of veterinary vaccines available in India;
(f) if so the details thereof; and
(g) the other major advancements of the NIAH during the last 5 years?

ANSWER
MINISTER OF STATE FOR FISHERIES, ANIMAL HUSBANDRY AND DAIRYING
(DR. SANJEEV KUMAR BALYAN)
(a) and (b): Yes Sir. The erstwhile Department of Animal Husbandry, Dairying and Fisheries, Ministry of Agriculture, GOI (now Department of Animal Husbandry & Dairying) has established National Institute of Animal Health with the following mandate:
1. To act as a nodal institute to recommend licensing of veterinary vaccines in the country
2. To make available facilities for quality control of veterinary vaccines and diagnostics
3. To make available standards for veterinary biologicals and diagnostics
This facility was inaugurated on 1st September, 2010 and thereafter general microbiological work and testing was initiated with collection of sera samples from various states of the country under Foot and Mouth Disease Control Programme (FMD-CP). The Institute got itself registered with statutory bodies like Committee for the Purpose of Control and Supervision of Experiments in Animals (CPCSEA), Institutional Animal Ethics Committee (IAEC), Registration and consent renewal with UP Pollution Control Board, and Institutional Bio-Safety Committee (IBSC). This was followed by in-house standardization of quality control testing of veterinary biologicals of Haemorrhagic Septicaemia, Ranikhet Disease, Black Quarter, Infectious Bursal Disease, Goat Pox, Sheep Pox, Peste de Petits Ruminant (PPR) and Enterotoxaemia Vaccine manufactured by state veterinary biological production units in the country
To initiate its regulatory function, the Institute developed its systems for undertaking quality control testing of veterinary biological Government of India, and it was recognized as Central Drugs Laboratory by the Ministry of Health and Family Welfare, Government of India for undertaking Quality Control Testing of veterinary biologicals, on two diseases namely Haemorrhagic Septicaemia (HS) and Ranikhet Disease (RD) vide Gazette notification no. G.S.R. 213(E), dated 11.3.2019. NIAH has since obtained ISO 9001:2015 certification (2016) for quality control of veterinary vaccines
(c) and (d): Yes Sir. The database for veterinary biological produced in the country has been created and is annexed at Annexure-I
(e) and (f): No Sir.
(g): Major advancements of NIAH during the last five years include:
• Reviewing and documentation quality testing of vaccines to be included in changes as per Indian Pharmacopia 2018 monographs, including protocols for bio-safety and bio-security
• MoUs with State Veterinary Universities including RAJUVAS Rajasthan, DUVASU Mathura, CCS University Meerut, NDRI Karnal and LUVAS Hisar for refining of SOPs and Quality Control testing
• Validating target studies on buffalo calves in the Animal House Facility of CCSNIAH with ICAR - IVRI for safety and potency testing of vaccine developed under the project “Development of a genetically engineered live vaccine for Brucellosis for animals”