All the three major vaccine units which were closed down by the government in January last year for non-compliance of GMP norms, CRI Kasuli, PII Coonoor and BCG Vaccine Lab Chennai, will be opened soon.
According to sources, the union health ministry has taken an in-principle decision in this regard, reversing its own decision taken last year by the then health minister Dr Anbumani Ramadoss which evoked public outcry against the decision.
In fact, Dr Ramadoss’ decision had put the central government in such a bad light that several NGOs working in the health sector had come together to file a writ petition in the Supreme Court in February this year. The NGOs argued that the closure of these three PSU vaccine units could have been avoided if the government had taken timely action to upgrade the shortfalls in WHO GMP compliance. In any case, compliance with WHO-GMP is mandatory only for exporting vaccines or buying them through the UNICEF vaccine procurement system and not for indigenous manufacture/purchase/immunization.
Besides the NGOs, the parliamentary committee on health and family welfare headed by Amar Singh had also lambasted the Union health ministry for its cavalier fashion with which the ministry has treated the issue of three closed PSU vaccine producing units. It had indicted the ministry for refusing to reopen these units even after these institutes rectifying the major shortcomings pointed out by the WHO inspection team.
The manufacturing licenses of these three institutes were suspended by the DCGI in January 2008, since they were not found in compliance with the GMP as per WHO standards. An expert panel under DCGI Dr Surinder Singh was set up in April, 2008 to study the existing infrastructure/facilities available with these institutes and explore the feasibility of conversion of existing laboratories into testing laboratories, utilisation of the existing facilities for setting up a residential training facility, and having some of the vaccines/anti-sera production at these institutes complying with GMP. The panel recommended for a Rs 500-crore revival plan for these three units.