Shanchol®, the oral cholera vaccine originally developed by Shantha Biotechnics, has received prequalification from the World Health Organization (WHO). This important milestone allows global procurement agencies such as UNICEF, Gavi, and PAHO to source Shanchol® for use in countries where cholera continues to pose a significant public health challenge.
“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 Dr. K.I. Varaprasad Reddy, Founder of Shantha Biotechnics.
To date, nearly 40 million doses of Shanchol® have been distributed worldwide through UNICEF-led vaccination campaigns. After a temporary halt in production under its previous ownership, GCBC Vaccines Pvt. Ltd. (formerly Shantha) has resumed manufacturing. The WHO conducted an on-site inspection and successfully transferred the prequalification to the new production facility.
Shanchol® remains the only oral cholera vaccine manufactured in India with WHO prequalification, highlighting the country’s vital contribution to maintaining a reliable global supply.
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“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 Dr. Ravi Penmetsa, Managing Director, GCBC Vaccines Pvt. Ltd.
“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 Dr. Vishy Chebrol, Executive Director, GCBC Vaccines Pvt. Ltd.