The Chennai based public sector vaccine manufacturing unit, BCG VL, will be self sufficient for production and supply of the anti-TB Bacillus Calmette-Guerin (BCG) vaccine for India’s National Immunisation Programme in another 15 months.
The unit will also be ready for export of the vaccine to other countries by the same period, according to sources from the union health ministry.
Currently the production in the old facility is only 10 lakh doses and it will go up to 80 million doses from February 2015. The unit will start large scale commercial production and supply of BCG vaccine in the same year, said the source. The company had resumed manufacturing of vaccine in December last year.
“The construction of the WHO cGMP facility building in the premises of the unit is nearing completion and orders for state-of-the-art equipment were given. All the civil work and erection of equipments and other systems will be completed in next three months. We are ready to hand over the working plant in full swing in August 2014, and hope that they can start the trial run in September. The unit will be ready to enter into commercial production by February 2015,” said Dr E A Subrahmaniam, project director, Hindustan Lifecare Limited (HLL), the nodal agency engaged in the construction of the new plants.
He said the total project cost is Rs.55 crore and the production capacity of the new facility is 80 million doses. The work for the new plant was started in September 2012. According to him the delay happened in completing the work was due to the long period required for getting approval from the Chennai Municipal Development Authority, and also a long time was spent for receiving approval from the pollution control board.
Regarding construction of plants at Pasteur Institute, Coonoor, Dr Subrahmaniam said since the unit is situated in a hill area, approvals from three authorities are needed and they are all in the waiting list. All the bottlenecks will be cleared in next 12 months. The civil work will be over in next three years. However, he expressed the hope that by August 2015, the new working plant will be ready for hand over.
PII is presently manufacturing DTP vaccine in the old facility for national immunisation programme.
Central Research Institute (CRI) in Kasauli started commercial production of DPT vaccine in the new WHO cGMP facility constructed by HLL in 2012.
HLL was assigned by the union health ministry to construct the plants on international standards at the three units after they were closed down by the ministry on 16.01.2008 citing failure of compliance to WHO GMP standards.