According to official sources, the government has granted approval for the export of the BCG vaccine, produced by the Serum Institute of India, to Canada.
The purpose of this export is to utilise the vaccine for immunotherapy in the treatment of bladder cancer.
The permission was sought by Prakash Kumar Singh, the director of the Serum Institute, who reached out to the Drugs Controller of India (DCGI) for the necessary approval.
BCG, in its capacity as an immunotherapy, is a freeze-dried preparation derived from a weakened strain of Mycobacterium bovis, commonly known as Bacillus Calmette Guerin.
The Serum Institute offers this product in two presentations: 40 mg and 80 mg.
The immunotherapy involves intravesical instillation, where the vaccine is administered directly into the bladder using a catheter.
It remains in the bladder lining for a specific duration, effectively targeting cancer cells without causing harm to other parts of the body.
The vaccine is also used to treat tuberculosis in humans. According to the World Health Organisation, it is used in countries with a high prevalence of TB to prevent childhood tuberculous meningitis and miliary disease.
Earlier in April this year, Venus Pharma GmbH, the company's German subsidiary, secured marketing authorisation from the UK for Cisplatin, a chemotherapy drug used as a first-line treatment for advanced ovarian cancer, testicular cancer and bladder carcinoma.
With agency inputs.
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