Serum Institute to launch BCG vaccine shortly

Ananth Iyer - Mumbai

Serum Institute of India is in the process of launching the Bacillus Calmette-Guerin (BCG) vaccine in India. The BCG vaccine is in severe short supply as the lone manufacturer of the vaccine in India - the Chennai-based BCG Vaccine Laboratory at Guindy - is unable to meet the requirements, a senior Serum Institute official told Express Pharma Pulse.

Though the date of the launch is yet to be finalized, company sources say the first five batches of BCG vaccine has been cleared by Central Research Institute, Kasauli. The large-scale manufacturing of the BCG vaccine will be done at the company’s newly built unit at Hadapsar, near Pune. This facility, admeasuring 200,000 sq ft, will also be utilized for the manufacture of Rabies and hepatitis B+DPT combination vaccine, company officials say.

India requires approximately 25 million doses of BCG vaccine. As against this, the government-owned BCG Laboratory produces a maximum of two million doses. Industry sources say that in order to meet the shortfall to an extent, the Government imports around 10-12 million doses from Unicef annually. However, the bigger problem, say Serum officials, is the availability of the vaccine. Since the BCG vaccine falls under the extended immunization programme and not under the universal immunization programme, the distribution of this vaccine is not an equal priority for the government, company officials add. ‘‘More than half the eligible population in the country do not have access to BCG vaccine. We have the capacity to produce 70-80 million doses and we are hopeful of meeting the entire requirement of India,’’ says Masood Ahmed, marketing manager, Serum Institute.

BCG is a strain of Mycobacterium bovis - the organism that causes TB in cattle. The vaccine was first prepared by the Pasteur Institute in France. Studies in the UK have shown the vaccine to give substantial (70-80 per cent) protection in both school children and neonates for up to 15 years. WHO does not recommend re-immunisation as it is of unproven benefit and may possibly cause more severe local reactions.

However, in India, the BCG vaccine has received a lot of flak after a study published in ICMR Journal in August 1999 noted ‘‘the overall protection by BCG, for all ages, against pulmonary tuberculosis was seen to be nil’’. The large-scale study tracked the health status of 2,81, 161 persons of 3.66 lakh population in Chingleput district of Tamil Nadu over a period of 15 years. The study was organized by the Tuberculosis Research Centre in co-operation with the WHO. Earlier, a Swedish epidemiologist, J Frimodt Moller, in the sixties, conducted a study in Nandanpalli district of Andhra Pradesh. The study, which had far too small sample size, showed a protection level of 31 per cent.

Despite the study, the ICMR advised the government to continue with the extended immunisation programme for tuberculosis, since the ICMR experts then felt that the study did not consider tuberculous meningitis or miliary tuberculosis. Although no large scale study on these two forms of tuberculosis has been conducted in India, a case control studies carried out at the Kalawati Saran Children’s Hospital in New Delhi reported an 84 per cent success from using BCG; the Government Medical College, Nagpur recorded 86.54 per cent; while the Institute of Child Health, Chennai showed 77 per cent success. A UK study in 1993 (published in the International Journal of Epidemiology) maintained that ‘‘the protective effect against meningeal and miliary TB was more homogenous and summary protective effect was high’’.