#India #Hyderabad #Shanchol #Shantha Biotechnics #WHO Prequalification

WHO Grants Prequalification for Shanchol®

In a significant milestone for global health, the World Health Organization (WHO) has granted prequalification to Shanchol®, an oral cholera vaccine originally developed by Shantha Biotechnics. This approval means that international procurement agencies like UNICEF, Gavi, and PAHO can now procure Shanchol® for use in regions where cholera continues to pose a major public health risk.

Dr. K.I. Varaprasad Reddy, the founder of Shantha Biotechnics, emphasized the importance of this achievement, stating, "Shanchol® was designed as an affordable and easily accessible solution for countries grappling with recurring cholera outbreaks. The WHO's prequalification further aligns with our founding mission." Over the years, approximately 40 million doses of Shanchol® have been distributed under various UNICEF-led vaccination campaigns, highlighting the vaccine's crucial role in combating cholera.

The production of Shanchol® had previously been on hold while under past ownership; however, GCBC Vaccines Pvt. Ltd., formerly known as Shantha, has resumed manufacturing with WHO oversight. The significance of Shanchol® being the only WHO-prequalified oral cholera vaccine produced in India underscores India's vital contribution to global health efforts.

Dr. Ravi Penmetsa, Managing Director of GCBC Vaccines Pvt. Ltd., remarked on the re-energized production: "Through our industry’s well-established sterile manufacturing processes, we ensure that this life-saving vaccine remains available globally. This milestone reinforces Shantha's commitment to public health." The goal is to make vaccines like Shanchol® reliably and affordably accessible to the countries most in need.

Furthermore, Dr. Vishy Chebrol, Executive Director of GCBC Vaccines Pvt. Ltd., stated, "We are dedicated to ensuring that vaccines such as Shanchol® reach the regions that need them the most while simultaneously working to develop more innovative and affordable vaccines from our pipeline, continuing Shantha's legacy of increasing access to life-saving immunizations.”

Understanding Shanchol®

Shanchol® is a bivalent and inactivated cholera vaccine that protects against the Vibrio cholerae O1 and O139 strains. It plays a critical role as a cornerstone in the response to cholera outbreaks, as well as in preventive vaccination campaigns, safeguarding millions across the globe. With the recent WHO prequalification, Shanchol® is set to maintain its extensive supply, meeting international demand and vaccination needs at the national level.

Background on the Manufacturer

Shanchol® was initially developed by Shantha Biotechnics, one of India’s pioneering biotech firms established in the 1990s. The company underwent acquisition by Sanofi in 2009, gaining recognition as a reliable vaccine supplier. In 2024, GCBC Vaccines Pvt. Ltd. acquired Shantha's operations, including Shanchol®. The resurgence of the brand aims to uphold its mission of delivering high-quality, affordable vaccines that expand access to life-saving immunizations worldwide. For more information, visit GCBC Vaccines.