Had shut down vaccine production after FDA served notice on poor infrastructure
After a three-year lull,the state-run Institute of Veterinary Biological Products in Pune,is looking for a new start through public private partnership.
The institute,under the Department of Animal Husbandry,was engaged in production of bacterial and viral vaccines. It had stopped production after a show-cause notice was issued by the Food and Drug Administration (FDA) three years ago citing poor infrastructure.
The closure of the institute,that manufactured 25 products with an average manufacturing of 400 lakh doses,had forced the department to procure vaccines from other companies.
We have put forth a proposal under the Rashtriya Krishi Vikas Yojana (RKVY) to appoint a consultant to study the private-public partnership model for this institute, animal husbandry commissioner D S Zagade told The Indian Express. Zagade said the RKVY had sanctioned Rs 25,000 crore for the country and the animal husbandry department has submitted its proposal to the state government last week.
He said this was the only way to get the institute re-started as the FDA had taken objection to the poor infrastructure for vaccines production.
The animal husbandry department is the most neglected department. We never have enough funds. The state government gets only Rs 400 crore for the animal husbandry department,of this Rs 300 crore is spend on salaries of the employees and only Rs 100 crore is dedicated for development work of the department,” said Zagade.
The institute,housed on 25 hectares of land in Aundh,was issued several notices by the FDA since 2003. It had also issued them a show-cause notice in 2007 for not complying to its norms.
Three years ago,the institute was forced to stop all kinds of vaccine production. Joint Commissioner of FDA (drugs) Sanjay Patil said the institute was repeatedly told to comply to norms. “The institute building was constructed in 1959. They had been following old methods of production. We objected to this and told them to construct new laboratories accordingly. However,their non-compliance forced us issue them show-cause notice,” said Patil.
At present,the institute procures vaccines from private companies and supplies it to the state. While they have ensured that there was no shortage,Zagade said,they can meet the FDA requirements only if they get enough funds.
The institute,started as the Serum and Vaccine Institute in Mumbai in 1947,used to produce only three products haemorrhagic septicaemia,black quarter and goat blood rinderpest disease vaccines. It was shifted to Pune in 1959 and the Ranikhed disease vaccine was produced in the specially established unit in Pune.