<p>Hyderabad: The oral cholera vaccine Shanchol, originally developed by Hyderabad-based Shantha Biotechnics, has once again received prequalification from the World Health Organization (WHO). </p><p>This recognition allows global procurement agencies such as UNICEF, Gavi, and PAHO to source Shanchol for use in countries where cholera continues to pose a major public health challenge.</p>.Trials of indigenous cholera vaccine successful so far.<p>WHO conducted an on-site inspection before transferring the prequalification to the new entity. Shanchol remains the only oral cholera vaccine manufactured in India with WHO prequalification, reaffirming the country’s vital role in ensuring the continuity of global cholera vaccine supply.</p><p>“Shanchol was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of vaccine carries forward that founding mission,” said Shantha Biotechnics, Founder Dr KI Varaprasad Reddy.<br><br>Over the years, nearly 40 million doses of Shanchol have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines Pvt Ltd (formerly Shantha Biotechnics) has now resumed manufacturing.</p><p><br>“As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform global healthcare. By resuming production of Shanchol, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide,” said GCBC Vaccines Pvt. Ltd, Managing Director, Dr Ravi Penmetsa.<br><br>Shanchol is a bivalent killed whole-cell oral cholera vaccine, effective against Vibrio cholerae O1 and O139. It has been a cornerstone of UNICEF-coordinated outbreak responses and preventive immunization campaigns, protecting millions of people worldwide.<br></p><p>“This milestone underscores Shantha’s renewed commitment to global health. Our focus is on ensuring that vaccines like Shanchol reach the countries that need them most, reliably and affordably. At the same time, we are working to bring other affordable and innovative vaccines from our pipeline to global markets, continuing Shantha’s tradition of expanding access to life-saving immunization,” said GCBC Vaccines Pvt. Ltd, Executive Director, Dr Vishy Chebrol.</p><p><br>With WHO PQ approval, Shanchol will continue to be supplied at scale to international demand and to meet country-level immunization needs.<br><br></p><p>Shanchol was originally developed by Shantha Biotechnics, founded in the 1990s as one of India’s pioneering biotech firms. The company was acquired by Sanofi in 2009, gaining global recognition as a trusted vaccine supplier. In 2024, Shantha’s facilities including Shanchol, were acquired by GCBC Vaccines Pvt Ltd.</p>
<p>Hyderabad: The oral cholera vaccine Shanchol, originally developed by Hyderabad-based Shantha Biotechnics, has once again received prequalification from the World Health Organization (WHO). </p><p>This recognition allows global procurement agencies such as UNICEF, Gavi, and PAHO to source Shanchol for use in countries where cholera continues to pose a major public health challenge.</p>.Trials of indigenous cholera vaccine successful so far.<p>WHO conducted an on-site inspection before transferring the prequalification to the new entity. Shanchol remains the only oral cholera vaccine manufactured in India with WHO prequalification, reaffirming the country’s vital role in ensuring the continuity of global cholera vaccine supply.</p><p>“Shanchol was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of vaccine carries forward that founding mission,” said Shantha Biotechnics, Founder Dr KI Varaprasad Reddy.<br><br>Over the years, nearly 40 million doses of Shanchol have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines Pvt Ltd (formerly Shantha Biotechnics) has now resumed manufacturing.</p><p><br>“As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform global healthcare. By resuming production of Shanchol, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide,” said GCBC Vaccines Pvt. Ltd, Managing Director, Dr Ravi Penmetsa.<br><br>Shanchol is a bivalent killed whole-cell oral cholera vaccine, effective against Vibrio cholerae O1 and O139. It has been a cornerstone of UNICEF-coordinated outbreak responses and preventive immunization campaigns, protecting millions of people worldwide.<br></p><p>“This milestone underscores Shantha’s renewed commitment to global health. Our focus is on ensuring that vaccines like Shanchol reach the countries that need them most, reliably and affordably. At the same time, we are working to bring other affordable and innovative vaccines from our pipeline to global markets, continuing Shantha’s tradition of expanding access to life-saving immunization,” said GCBC Vaccines Pvt. Ltd, Executive Director, Dr Vishy Chebrol.</p><p><br>With WHO PQ approval, Shanchol will continue to be supplied at scale to international demand and to meet country-level immunization needs.<br><br></p><p>Shanchol was originally developed by Shantha Biotechnics, founded in the 1990s as one of India’s pioneering biotech firms. The company was acquired by Sanofi in 2009, gaining global recognition as a trusted vaccine supplier. In 2024, Shantha’s facilities including Shanchol, were acquired by GCBC Vaccines Pvt Ltd.</p>