Oral cholera vaccine Shanchol gets WHO prequalification

Made in Hyderabad oral cholera vaccine Shanchol, originally developed by Shantha Biotechnics and whose production resumed recently under a new management, has received World Health Organization (WHO) prequalification.

For global procurement agencies such as UNICEF, Gavi and PAHO, the prequalification will be an enabling provision to source Shanchol for use in countries where cholera remains a major public health challenge, said GCBC Vaccines, which is a part of Gland Family Office that in April 2024 acquired manufacturing facilities of Shantha in Medchal and Muppireddypally, near Hyderabad, from Sanofi. Founded in the 1990s, Shantha Biotechnics was acquired by Sanofi in 2009.

Inspection and transfer

“By resuming production of Shanchol, we are bringing the same rigour and reliability to ensure this life-saving vaccine remains available worldwide,” GCBC Vaccines managing director, Ravi Penmetsa said. Over the years, close to 40 million doses of the vaccine have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines (formerly Shantha) resumed manufacturing, with WHO conducting an on-site inspection and transferring the prequalification.

It is the only oral cholera vaccine manufactured in India with WHO prequalification, underscoring India’s critical role in ensuring continuity of global supply, the company said in a release on Tuesday (October 7, 2025).

Shantha Biotechnics founder K.I. Varaprasad Reddy said “Shanchol was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of vaccine carries forward that founding mission.”

More on cards

The focus is on ensuring such vaccines reach the countries that need them most, reliably and affordably, GCBC Vaccines executive director Vishy Chebrol said. “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.”

With the WHO prequalification approval, Shanchol — which is a bivalent killed whole-cell oral cholera vaccine effective against Vibrio cholerae O1 and O139 — will continue to be supplied at scale to international demand and to meet country-level immunisation needs, the company said.