Hailing the private vaccine units for their supply and quality of vaccines for the country’s immunisation programs, the Drugs Controller General of India (DCGI) Dr G N Singh said if the three PSUs – BCG VL Chennai, PII Coonoor and CRI Kasauli—properly comply with the norms of cGMP standards, his office will show green signal to them for starting of commercial production.

While speaking to Pharmabiz, the DCGI said soon after taking over the charge of his office, he paid a visit to all the three units. It was found that the operating conditions of the PSU units were not complying to the standards.

When the ongoing upgradation work in the labs was pointed out, he said “Compliance is the most important part. Once the units are prepared to comply with the standards of international GMP, we will permit them to go ahead with the production. Now the private companies are doing well and following WHO norms. We are concerned about the health of the people, so quality vaccine is very important.”

But Dr GN Singh said he or the union government is not against the public sector units and their operations, but will not compromise in quality aspects.

When contacted the state drugs control director G Selvaraju, said “We have already given licences to the units (BCG VL and PII) for starting production, but it is upto the DCGI to decide whether to start production or not”.

E A Subrahmaniam, general manager (projects) of the Hindustan Lifecare Limited (HLL), the nodal agency carrying out the upgradation work in the three companies, said the construction of the new building at the BCG Vaccine Lab in Chennai will be completed in another 24 months time. Regarding Pasteur Institute, the upgradation work is about to finish in a few months from now. The work in the CRI has already been completed and the building was handed over to the company.

He said the DCGI will conduct an inspection at the Central Research Institute in Kasauli in next week to take stock of the situation.

The future of the Chennai based BCG Vaccine Lab will be in trouble if it does not commence manufacture before December 31 this year as the validity of the manufacturing licence that was renewed by the drug control authorities in October last will expire. The DC department had renewed the licences of BCG along with Pasteur Institute. Both the institutes have not commenced production and supply of vaccines even after the renewal of licences in 2010. Both the units are yet to overcome the technical hurdles, sources in the units said.