India has reasserted its leadership in global vaccine supply following the World Health Organization’s (WHO) re-approval of Shanchol, the country’s only WHO-prequalified oral cholera vaccine.
Originally developed by Hyderabad-based Shantha Biotechnics, Shanchol was designed as a cost-effective and accessible solution for nations struggling with recurring cholera outbreaks.
With production now resumed under GCBC Vaccines Pvt. Ltd. (formerly Shantha Biotechnics), the vaccine has regained WHO prequalification, paving the way for its continued global distribution.
The renewed certification enables international agencies such as UNICEF and Gavi to procure Shanchol for cholera prevention and outbreak response in vulnerable countries.
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The move highlights India’s crucial role in ensuring the availability of affordable, high-quality vaccines for global health programmes.
“Shanchol was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of the vaccine carries forward that founding mission,” said K.I. Varaprasad Reddy, Founder of Shantha Biotechnics.
To date, nearly 40 million doses of Shanchol have been distributed worldwide through UNICEF-led immunisation campaigns. After production was temporarily halted under previous ownership, GCBC Vaccines has now resumed manufacturing, following WHO’s on-site inspection and transfer of prequalification.
“As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform global healthcare,”said Ravi Penmetsa, Managing Director of GCBC Vaccines Pvt. Ltd. “By resuming production of Shanchol, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide. “
Executive Director, Vishy Chebrol, added that the milestone “underscores Shantha’s renewed commitment to global health,” reaffirming the company’s goal of delivering vaccines “reliably and affordably” to countries most in need.
Shanchol, a bivalent killed whole-cell oral cholera vaccine, protects against Vibrio cholerae and has been central to global cholera control efforts.
With WHO’s renewed endorsement, India is once again positioned as a key player in maintaining a steady global supply of this essential vaccine.
