Shantha Biotech's 5-in-1 vaccine up for WHO review

For Shantha Biotech, choppy waters may calm down soon. It's been three years since Shan-5, its 5-in-1 vaccine, was disqualified by the WHO on quality concerns, but the vaccine is now up for reassesment. CNBC-TV18’s Archana Shukla reports.

Also read: DIPP to send proposal to PMO on review of pharma FDI policy A single vaccine to protect infants against five diseases -- diptheria, pertusis, Hep-B, tetanus, and a bacterium causing pnemonia and meningitis -- was a major factor in Sanofi buying Shantha Biotech for USD 800 million in 2009. But the vaccine was disqualified by the WHO, and Sanofi's big plans came to naught. But now, there is a glimmer of hope, with the World Health Organisation preparing for a re-inspection of Shantha's facilities that manufacture the vaccine. Nata Menabde, India representative, WHO says “We are preparing for a re-inspection along with some other international regulators.” But the three-year ban on the vaccine, which came after the WHO found white sediments sticking to the vaccine's glass vials, has cost Shantha a pretty penny. The first to go was the USD 340 million supply contract with the WHO. This led to the removal of the drug from the global markets, causing Shantha's annual sales of nearly Rs 500 crore to fall to Rs 100 crore. The disqualification meant Shantha had to revamp its management cadre and go back to the drawing board. With the drug in redevelopment, Shantha also missed out on participating in the 2013-15 UNICEF contract. But now, Shantha says the redeveloped vaccine has completed Phase-3 clinical trials, and is ready for safety studies. Sanofi also has a lot riding on this reassessment starting with its plans to make Shantha its vaccine hub for emerging markets. But the French drugmaker is confident that Shan5 will return, bringing with it a significant contribution to the company's Hepatitis-B coverage, and becoming the stepping stone to the next version - Shan6.