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Renewal of licences of BCG VL, PIIC may not ensure supply of vaccine to NIP for 2012

Peethaambaran Kunnathoor, Chennai
Monday, October 17, 2011, 08:00 Hrs  [IST]

The renewal of manufacturing licences of BCG VL Chennai and Pasteur Institute of India, Coonoor may not fetch any desired result for the country’s national immunisation programme for the year 2012 despite immense pressure from the union health ministry, as the units are not in a fit condition to manufacture even a drop of vaccine because of technical hurdles, according to sources in the units.

It is alleged that the poor manufacturing condition of the companies may help the private players take advantage of the situation by enabling them to supply the total quota of all vaccines for one more year. Moreover, these institutes have not participated in the tender procedure for the year 2010-2011 issued by the Ministry of Health & FW. It is alleged that the units are now unfit for production of large  quantities of vaccines due to their poor facilities.

The licences were renewed only last month because of union health ministry’s incessant pressure. Even before that these two public sector players were allowed to manufacture vaccines and they even made attempts to supply their stock vaccines which were later found substandard and time barred. The union health ministry had asked these institutes how much doses of BCG and DPT vaccines they could supply for 2011 period when they had no licences.

There are so many technical hurdles prevailing in both the institutes to start the production. The central and state inspection teams have found deficiencies in the GMP facilities of both the units which have to be rectified before resuming production. The HLL Lifecare Ltd was engaged to construct new facilities in the premises, but it is moving at a snail’s pace.

The Effluent Treatment Plants (ETP) in the institutes are not in working conditions. Water for Injection (WFI) Plants have to be installed and commissioned at both the centres after having validated as per cGMP norms. Further environmental clearance has to be obtained from the Ministry of Environment on the usage of biological materials and genetically modified organisms to manufacture vaccines.

One of the reasons for the closure was lack of adequate staff in these institutes and this shortage also has to be addressed before starting production.

Even without renewing the manufacturing licence, the directors of these institutes informed the Vaccine Procurement Cell last year that they would provide 340 lakhs doses of DPT to immunisation program by the end of 2010. Later they have desisted from the attempt because of continuing failures.

 

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