The BCG Vaccine Lab in Chennai has initiated steps for pilot production of Bacillus Calmette-Guerin vaccine, after a period of thirty months. On July 25, the scientists in the Lab have opened the seed lot system which was kept in the cold storage of the unit after its closure in January, 2008.
The seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus or bacteria. The seed-lot must be tested for its safety by preparing a batch of vaccine from it.
Sharing the details of the development, Dr Usha Soren Singh, the director of the unit said the pilot vaccine production will require a period of 14 weeks. "We are starting the pilot production. We have to make three consecutive batches of the vaccine which will be then sent to the National Control Lab for testing. After getting their okay, we will go for commercial production," the director said. The authorities hope that the unit can start the routine production in December this year.
The BCG lab was closed in January 2008 along with other two public sector vaccine manufacturing units for not complying WHO GMP norms. The Chennai vaccine unit is the last one to enter into production after the present Union Health Ministry gave permission to the closed units to resume their work in the same facilities they have. The ministry has also given an order to the units to equip their labs with modern facilities in three years.
CRI Kasauli and PII Coonoor have started production of various vaccines four months ago. They have also completed the renovation work of the existing labs and constructing new GMP facilities. The BCG Lab in Chennai could not start the work along with them due to technical reasons.
When contacted, some employees in the Lab said that the production commenced at the same facility of the old building for which no renovation was done. They asked if the unit can start manufacture of vaccines in the same facilities why the former Union Health Minister had closed this unit.
The BCG Vaccine produced in 10 dose vials is being supplied to the country's Expanded Programme of Immunization. It is also supplied to private medical institutes and Hospitals on prescription. The vaccine is used for the control of Childhood Tuberculosis and Tuberculous Meningitis in children.
The unit also manufactures BCG Therapeutic (40mg) for cancer Chemotherapy, especially Carcinoma of Urinary Bladder. The Lab of the unit acts as National Quality Control Laboratory for BCG Vaccine.