The supply had been stopped about the WHO highlighted certain issues with the vaccine and Shantha's non-executive chairman K.I. Varaprasad Reddy revealed that Sanofi had invested over 125 million euros in addressing the issues. Reddy added that the company hopes for annual earnings of Rs 500 crore following the resumption of supplies.
"We received a setback in 2010 due to sedimentation issues with the vaccines and WHO withdrew the prequalification in 2010. Losing the prequalification was indeed a pressure on us but now we have come out of it with a commitment for a better product. We have done the largest clinical trial of the vaccine with 1,100 infants and 11 medical school study centres across India", the CEO of Shantha Biotechnics, Harish Iyer said.