WHO Prequalifies Shanchol®, Securing Global Supply of India’s Oral Cholera Vaccine
Hyderabad-based GCBC Vaccines revives production of Shanchol® to strengthen global cholera prevention efforts.
The World Health Organization (WHO) has officially prequalified Shanchol, the oral cholera vaccine originally developed by Shantha Biotechnics, ensuring renewed access to this life-saving immunization worldwide.
The WHO prequalification enables international procurement agencies including UNICEF, Gavi, and the Pan American Health Organization (PAHO) to source Shanchol for use in countries where cholera remains a serious public health challenge. The vaccine continues to play a key role in outbreak response and preventive immunization campaigns across cholera-endemic regions.
Reviving a Global Health Essential
Following a pause in production under previous ownership, GCBC Vaccines Pvt. Ltd. (formerly Shantha Biotechnics) has resumed manufacturing of Shanchol. WHO conducted an on-site inspection and transferred prequalification, confirming that the vaccine meets global standards for quality, safety, and efficacy.
To date, nearly 40 million doses of Shanchol have been supplied worldwide through UNICEF-led vaccination campaigns. With prequalification reinstated, supply continuity is ensured at a time when cholera outbreaks are increasing globally.
“Shanchol was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of Shanchol carries forward that founding mission,” said Dr. K. I. Varaprasad Reddy, Founder of Shantha Biotechnics.
India’s Role in Global Vaccine Supply
Shanchol is currently the only WHO-prequalified oral cholera vaccine manufactured in India, underscoring the country’s leadership in global vaccine supply and access.
“As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform healthcare. By resuming production of Shanchol, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide,” said Dr. Ravi Penmetsa, Managing Director, GCBC Vaccines Pvt. Ltd.
“This milestone underscores Shantha’s renewed commitment to global health. Our goal is to make sure Shanchol and other affordable vaccines from our pipeline reach the countries that need them most,” said Dr. Vishy Chebrol, Executive Director, GCBC Vaccines Pvt. Ltd.
About Shanchol
Shanchol is a bivalent killed whole-cell oral cholera vaccine effective against Vibrio cholerae O1 and O139. It has been central to UNICEF-coordinated outbreak responses and preventive immunization campaigns, protecting millions of people across Asia and Africa.
With WHO prequalification approval, Shanchol will continue to be supplied at scale to meet international demand and national immunization program needs, reinforcing India’s contribution to global health security.
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BioFocus Newsroom