The immunization programme in the country may come to a total halt soon with the cancellation of the production licenses of the three vaccine manufacturing institutes under the Union Health ministry prior to the setting up of a centralized vaccine manufacturing unit near here, it is learnt.

The BCG Vaccine Laboratory in Chennai, the Pasteur Institute of India (PII) in Coonoor in the Nilgiris, and the Central Research Institute (CRI) at Kasauli in Himachal Pradesh have been served with orders to cease their production till further notice. These are the three oldest government vaccine manufacturing units in the country.

Except the BCG Lab of Chennai, the Pasteur Institute and the CRI are of more than a century old establishments whereas BCG Lab has a history of six decades of existence. Now the BCG Lab and the other two Institutes have already stopped their production.

However, the director of the BCG Lab in Chennai is hoping that they may able to resume the production before long as the irregularities found by the inspection team are being rectified on a war footing by the Institute so that the authorities may revoke the cancellation order, which is effective since January 15 this year.

The BCG Lab has been manufacturing anti-tuberculosis Bacillus Calmette-Guerin vaccine (BCG Vaccine) for the last sixty years, where as the Pasteur Institute of India (PII) in Coonoor were producing DTP vaccines, Vero-cell-derived rabies vaccine and Tissue culture anti-rabies vaccines.

The Central Research Institute (CRI) at Kasauli was the main contributor of the DPT group of vaccines to the Immunisation Program, according to medical experts in the field.

Dr Elangeswaran, director of the BCG Lab (who is also the director of PII, Coonoor) told Pharmabiz that the inspection team's findings in respect of the deficiencies and irregularities were true to an extent and had to be rectified. So far 75 per cent of them have been corrected and the remaining will be completed in a fortnight's time.

The major deficiencies that the inspection team detected were with regard to documentation, infrastructure and quality assurance (GMP compliance).

Dr Elangeswaran said, " In the case of documentation we have corrected everything. As far as the Staff and Infrastructure facilities are concerned 75 per cent of the deficiencies have been cleared. As per WHO and GMP norms, training has been given to the staff. After their re-inspection, I hope the authorities may re-invoke the suspended licence of the Institute".

He added that since the building, which is housing the Institute including the laboratory and the office complex, is more than one hundred years' old, it requires renovation to which nothing can be done presently.

A total of 122 employees are working in the BCG Lab. Out of this, 90 per cent are going to be retired from service in a couple of years.

The decision to cancel the licence was as a result of two rounds of inspections at the Institute, one in August 2007 and the second in January 7, 2008 by a GMP assessment committee constituted by the health ministry. In December last year the Institute was served a show-cause notice as to why its licence should not be suspended.

Along with the suspension orders, the DCGI has also directed all the three units not to supply the stocks they hold and to stop procurement of raw materials.

Meanwhile a proposal to set up a centralized Vaccine Park has been put forward Dr Elangeswaran to the government. As per the plan, the park would be constructed as per global standards at a cost of approximately Rs 200 crore.