Abstract
BCG vaccine has been in use globally to control the tuberculosis since the year 1921 and there has been significant achievement to curtail the disease. The important tests as per pharmacopoeial requirements including count of viable units (CVU) and excessive dermal reactivity (EDR) are required to be performed for ensuring the quality of BCG vaccine. In order to see the trend analysis of EDR of BCG vaccine used in India, a study has been carried out using 35 batches of BCG vaccine manufactured by two different manufacturers. The results of EDR of 16 batches of manufacturer-1 and 19 batches from manufacturer-2 ranged from 2.7mm to 3.2mm and1.9mm to 3.9mm respectively and the results are not markedly different from that of reference vaccine. The preliminary observation based on 16 batches suggests that there is some correlation between CVU and EDR of BCG vaccine, however more batches of BCG vaccine need to be tested to draw a clear correlation between these two tests. The critical EDR test is required to be performed regularly till the suitable alternate in vitro method is established. Overall results of the study suggest that BCG vaccine used in India is safe and potent.
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