SII manufactured BCG vaccine gets export nod to treat bladder cancer

The government has approved the export of BCG vaccine manufactured by the Serum Institute of India to Canada for immunotherapy to treat bladder cancer, official sources said on Monday.The permission was granted after Prakash Kumar Singh, director, Serum Institute, wrote to the Drugs Controller of India (DCGI) seeking approval to export BCG for immunotherapy to Canada, they said.

BCG as immunotherapy is a live freeze-dried preparation derived from attenuated strain of Mycobacterium bovis (Bacillus Calmette Guerin).

The product is for intravesical instillation and is available from the Serum Institute in 40 mg and 80 mg presentations, the sources said.


As part of the therapy, the vaccine is administered into the bladder through a catheter where it stays in the lining of the bladder for a specific duration affecting the cells and fighting cancer without impacting other body parts.