The director of BCG Vaccine Lab in Chennai hopes to resume commercial production and supply of the anti-tuberculosis Bacillus Calmette-Guerin (BCG) vaccine from the mid of November this year, on the lines of Pasteur Institute of India, Coonoor, and Central Research Institute, Kasauli.
The Lab is waiting for a positive report of the three batches of samples it sent in June last to the Central Drug Testing Laboratory (CDTL) for testing and approval. Once a favourable report is received, the supply of vaccine can be started with in 15 days, said Dr H G Bramhne, the director of BCG VL, with optimism. Whereas, the PII and the CRI started supply long back.
But, the BCG VL will be in trouble provided it does not commence manufacture before December 31 this year because the validity of the manufacturing licences that were renewed by the drug control authorities in October last will go expired. The DC department had renewed the licences of BCG along with Pasteur Institute which had begun supply of DPT vaccine on June 26.
“We have already started manufacturing and the process is going on. CDL is asking many queries and we are answering them. The old machineries were replaced with modern equipment and new instruments were bought. Now all the problems have been solved and we are waiting for the final report. We expect to supply 14 lakh doses of BCG vaccine per month to the country’s UIP from November 15th this year,” said a director who initiated some rectification work in the lab including problems with the strains.
Earlier he had told Pharmabiz that the company was aggressively working to start supply of vaccine to the Central Vaccine Procurement Cell by the end of this year. But somehow, the CDL is delaying in divulging the test report which is the basic requirement to obtain approval from the authority. Dr Bramhne said he is hopeful that CDL would issue report in another one week.
The drug control department in Chennai renewed the licences upto December 2012 by putting forward some conditions that all the deficiencies cited in the order of suspension of licences dated 16.01.2008, should be rectified before the validity period of the licences ends. But BCG Lab and Pasteur Institute are still not complying WHO cGMP regulations and the work for upgradation has not been fully started in these public sector units.