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Expert panel to conduct study of 3 vaccine PSUs from June 30

Our Bureau, ChennaiTuesday, June 10, 2008, 08:00 Hrs  [IST]

The Expert Committee appointed by the Union Health Ministry to inspect the three Public Sector Vaccine Units, whose licenses were suspended for non-compliance with GMP norms from January 15 this year, will conduct an on the spot study visit to take stock of the situation of the PSUs from June 30 to July 12. The Health Ministry has decided to convert these institutes into Testing Laboratories and Training Centres for Vaccine and Sera. The expert committee headed by the DCGI will assess the existing infrastructure facilities available with these units and explore feasibilities of conversion of them into testing and training units. The panel will visit the Central Research Institute, Kasauli on 30th of this Month and continue the inspection there until July 2. On July 9 and 10 they will call at the BCG Vaccine Lab in Chennai, and 10 and 12 are the dates scheduled for inspecting the Pasteur Institute at Coonoor. The Expert Panel, after a thorough inspection, will submit its recommendations with guidelines with in three months to the Ministry of Health. In this regard, the DCGI has already issued circulars to the directors of the three units and the copies were served on to the panel members also. Apart from the DCGI, the chairman of the team, Dr Sokhey, advisor to CDSCO, Dr J Deshpande, director -ERC, ICMR, Mumbai, Dr Sunil Gupta, JD, NICD, Arvind Kukrety, Dr V G Somani, ADCs, Dr Anil Chawla, vice president-Panacea Biotech, Delhi and Dr Sunil Gairola, director, Serum Institute of India, Pune are the members of the panel. The ministry had cancelled the licenses for vaccine production after the World Health Organisation found the units to be not compliant with GMP standards. The Health Minister, Dr Ambumonyb Ramdoss had earlier justified that the WHO would de-recognize India's National Regulatory Authority (NRA) if the licenses were not cancelled. BCG Vaccine Lab, Chennai - BCG, PII, Coonoor were manufacturing DPT, DT, TT and TCARV vaccines, and CRI, Kasauli was producing DPT, DT, TT, JE, Anti Rabies Serum, CAVS, Diagnostic Antigen, NHS, and ATS ,the essential vaccines that are needed for the national immunization program of the country. Last Month, the Union Health Minister in Chennai said that if the team's findings are suitable for a possible restructuring, its recommendations would be implemented in favour of revival of vaccine production in the particular units. But now, according to the sources, his office has decided to convert these century old units into testing labs.

 
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