The BCG laboratory, established in 1948, producing anti-tuberculosis Bacillus Calmette-Guerin Vaccine has an installed capacity of 80 million doses of vaccine a year. A subordinate office under the DGHS, the laboratory initially produced liquid BCG vaccine and Tuberculins with the help of the Statens Serum Institute, Copenhagen, Denmark, through the WHO. The strain used for the vaccine was DANISH–1331. As the liquid BCG vaccine was found to have a short shelf-life, the laboratory started manufacturing freeze-dried vaccine. When difficulties arose in obtaining the Danish seed, the factory started to make its own lot. The laboratory is the sole contributor of BCG vaccines to the Central government’s Expanded Programme of Immunisation (EPI). Seen in the background of the success and impact of the immunisation programmes, the role played by the Chennai laboratory in controlling the spread of tuberculosis, particularly in respect of childhood TB and tuberculosis meningitis in children, is commendable. At the time of suspension of production, the laboratory was engaged in producing freeze-dried BCG vaccine (20 doses) for the control of childhood TB and TB meningitis in children, and to meet the needs of the EPI; freeze-dried BCG therapeutic vaccine (40 mg) for cancer chemotherapy, particularly carcinoma of urinary bladder; and purified protein derivative RT-23 (Mantoux reagent) for diagnosis. It also served as the National Quality Control Laboratory for the BCG vaccine, and provided training facilities. Given that the laboratory has been meeting the entire BCG vaccine needs of the country, the stoppage of production could throw the immunisation programme out of gear. The shortcomings found by the WHO team cannot be ignored, though. |