Nearly two years after it recalled its five-in-one pentavalent vaccine following concerns raised by the World Health Organisation (WHO) over its safety, the Sanofi-Aventis owned Shantha Biotech is hoping to re-introduce the vaccine by 2013 after going through a fresh WHO audit.
Shantha Bio is in the process of making some changes to the manufacturing process so as to raise the quality standards of the vaccine to get WHO's approval.
The company recalled the vaccine from the market after WHO detected some white sediment, raising concerns over its safety in 2010. The vaccine is considered a critical one, as it is meant to protect babies from five illnesses—diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae.
“We have analysed the root cause and identified the component that needed some changes. We are investing significantly in upgrading our equipment and improving our quality standards of vaccines to clear audits faster in the future,” Mr Harish Iyer, Managing Director and CEO, told media persons on the sidelines of the Bio-Asia meet here.
Pipeline
The company has in the pipeline three more vaccines — the six-way hexavalent, rota that protects infants from rotaviruses leading to severe diarrhoea and HPV (human papilloma virus associated with prevention of cervical cancer) vaccines. “All of these will go through WHO audit before we hit the market,” Mr Iyer said.
The global requirement of pentavalent and hexavalent vaccines is estimated at about 250 million doses annually. “We have to see how much of these we are allotted (through the tendering process). Depending on this, we will upgrade our manufacturing facilities here,” Mr Iyer said.
The company is also mulling bringing measles vaccines to India through its parent company, Sanofi. India needs to expand its portfolio of vaccines, he pointed out.
“We will be investing about $300 million to set up a manufacturing facility near Hyderabad,” he said.