Even after the Union Health Ministry has confirmed its stand of reopening the closed three vaccine manufacturing units three months ago, the Chennai-based BCG Vaccine Lab could not file a structured project report to the central ministry in respect of its upgradation, it is learnt.

Out of the three decades old public sector vaccine production units, PII Coonoor and CRI Kasauli have already initiated into renovation of their existing units and submitted projects for establishing WHO GMP facilities. The Union Health Ministry had expressed its willingness to reopen all the three units as soon as the present government has come into power, and asked them to submit the project reports for verification and follow up action.

According to sources from the BCG Vaccine Lab, the reason cited for not drafting a roadmap in establishing GMP facilities and other physical development is because of the delay in the arrival of the Core Committee team constituted by the Health Ministry and led by DCGI to the institute to inspect the facility and assess the situation for future plans. The same team had visited CRI more than three times and two times to PII. Following these visits, Rs 22 crore have been released to the Kasauli Unit for purchase of machinery as part of renovation purpose. The renovation project involving Rs 280 crore submitted by PII is under consideration of the Health Ministry.

When contacted the newly appointed director at the BCG, Dr Usha Soren Singh, said " We are waiting the arrival of the DCGI and his team. They will inspect the site and assess the situation. According to their assessment, they will decide what to do and when to do something. But we hope that we will be able to resume production along with other two units." However, she said the unit expects the team's visit may take place by the end of this Month.

To a question what is the status of the 280 lakh doses of BCG vaccine that were lying in the cold storages of the Lab, the director said she could not get enough time to look into this matter. Entire stock of the BCG vaccine which was due for expiry in July was in the BCG Lab ever since the unit was shut down in January, 2008.

In 2007, prior to the issuance of suspension order to the unit, the then health ministry appointed inspection team had detected some major deficiencies with regard to documentation, infrastructure and quality assurance (GMP compliance). The building, which is housing the Institute including the laboratory and the office complex, is more than one hundred years' old. The unit has been manufacturing anti-tuberculosis Bacillus Calmette-Guerin vaccine (BCG Vaccine) for the last sixty years,

The decision to cancel the license 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.