#India #WHO #Hyderabad #cholera vaccine #Shanchol®

WHO Prequalifies Shanchol® Oral Cholera Vaccine

On October 8, 2025, the World Health Organization (WHO) announced the prequalification of Shanchol®, the oral cholera vaccine originally developed by Shantha Biotechnics. This important milestone allows international procurement agencies like UNICEF, Gavi, and PAHO to acquire Shanchol® for deployment in regions where cholera remains a significant public health challenge.

Dr. K.I. Varaprasad Reddy, founder of Shantha Biotechnics, stated, "Shanchol® was designed as an affordable and accessible solution for countries facing recurrent cholera outbreaks. The WHO's prequalification of Shanchol® propels our foundational mission forward." With nearly 40 million doses of Shanchol® administered globally through vaccination campaigns led by UNICEF, the vaccine has had a profound impact on managing cholera outbreaks.

Following a production interruption under previous ownership, GCBC Vaccines Pvt. Ltd. (formerly Shantha) has resumed the manufacturing of Shanchol® post an on-site inspection by the WHO and the transfer of the prequalification certificate. Remarkably, Shanchol® remains the only WHO prequalified oral cholera vaccine produced in India, highlighting the country's critical role in ensuring the global supply chain’s stability.

Dr. Ravi Penmetsa, CEO of GCBC Vaccines Pvt. Ltd., emphasized, "As part of the founding family of Gland Pharma, I have witnessed how India’s top-tier sterile product manufacturing can revolutionize global healthcare. By resuming Shanchol®'s production, we are committed to maintaining the same rigorous standards to guarantee the vaccine's global availability."

Dr. Vishy Chebrol, CEO of GCBC Vaccines Pvt. Ltd., echoed this sentiment, stating, "This achievement reinforces Shantha’s renewed commitment to global health. We aim to ensure that vaccines like Shanchol® reliably reach countries in greatest need affordably. Additionally, we are working on introducing other affordable and innovative vaccines from our developmental pipeline to global markets, continuing Shantha's legacy by expanding access to vital immunizations."

About Shanchol®

Shanchol® is a bivalent oral cholera vaccine made from killed whole cells, effective against Vibrio cholerae serogroups O1 and O139. It has been a cornerstone in outbreak response and preventive immunization campaigns coordinated by UNICEF, protecting millions of individuals worldwide. With the WHO’s backing, Shanchol® will continue to be distributed on a large scale to meet international demand and immunization needs across countries.

Manufacturer Background

Initially developed by Shantha Biotechnics, a pioneering Indian biotech firm established in the 1990s, Shanchol® gained global recognition after being acquired by Sanofi in 2009 and has since evolved into a reliable vaccine provider. In 2024, the facilities housing Shantha products, including Shanchol®, were acquired by GCBC Vaccines Pvt. Ltd. The legacy of Shantha thrives on through the revitalization of the company and its commitment to deliver high-quality, affordable vaccines that broaden access to essential immunizations globally.

For more information, please visit GCBC Vaccines.