The oral cholera vaccine, Shanchol, proudly developed in Hyderabad, has achieved a significant milestone by receiving prequalification from the World Health Organization (WHO). This vaccine, initially created by Shantha Biotechnics, recently recommenced production under new leadership, marking a new chapter in its global impact.
This prequalification is a game-changer for international procurement bodies like UNICEF, Gavi, and PAHO, as it allows them to readily acquire Shanchol for distribution in regions severely affected by cholera. GCBC Vaccines, a division of Gland Family Office, announced the approval. Notably, GCBC Vaccines took over Shantha’s manufacturing sites in Medchal and Muppireddypally, near Hyderabad, from Sanofi in April 2024, subsequently restarting vaccine production. Shantha Biotechnics, the original developer of the vaccine, was founded in the 1990s and later acquired by Sanofi in 2009.
Rigorous Inspection and Seamless Transfer
Ravi Penmetsa, Managing Director of GCBC Vaccines, emphasized their commitment: “By resuming production of Shanchol, we are reinstating the same high standards of rigor and reliability to ensure this vital vaccine is accessible globally.” Historically, nearly 40 million doses of Shanchol have been distributed worldwide through UNICEF-managed vaccination programs. After a period of inactivity under its previous owners, GCBC Vaccines (formerly Shantha) restarted manufacturing. The WHO conducted a thorough on-site inspection before officially transferring the prequalification, affirming the vaccine’s continued quality and safety.
According to a company statement released on Tuesday (October 7, 2025), Shanchol holds the distinction of being the only oral cholera vaccine produced in India to receive WHO prequalification. This achievement highlights India’s indispensable contribution to maintaining a consistent global supply of essential medicines.
K.I. Varaprasad Reddy, founder of Shantha Biotechnics, expressed his satisfaction, stating that “Shanchol was originally envisioned as an affordable and readily available solution for nations grappling with recurrent cholera epidemics. This WHO prequalification ensures that this foundational mission continues to be upheld.”
Future Innovations in the Pipeline
Vishy Chebrol, Executive Director of GCBC Vaccines, affirmed their dedication to global health: “Our primary goal is to guarantee that crucial vaccines are delivered reliably and affordably to the communities that need them most.” He added, “Concurrently, we are developing other cost-effective and groundbreaking vaccines from our research pipeline for international markets, thereby extending Shantha’s legacy of broadening access to vital immunization.”
With the stamp of WHO prequalification, Shanchol—a bivalent killed whole-cell oral cholera vaccine proven effective against both Vibrio cholerae O1 and O139 strains—is now poised for large-scale distribution. This will help meet international demand and fulfill immunization requirements at a country level, further solidifying its role in combating cholera globally.