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Shantha
gets WHO approval for Shanvac B vaccine
EPP
News Bureau - Hyderabad
Shantha
Biotechnics Private Ltd here, which was first to launch the indigenously
developed hepatitis-B vaccine in the country, has secured the WHO
certification for its product ‘Shanvac B’. Shantha is
the only company in India to get this certification for hepatitis-B
vaccine. The company’s product will be added to the WHO list
of prequalified vaccines.
Company
executive director, Khalil Ahmed told Express Pharma Pulse that
the WHO process took two years, involving random testing of vaccine
lots for quality and consistency, including verification of good
manufacturing practices and stringent auditing of the plant. He
said for the first time an Indian vaccine producing company would
be eligible for supply to all United Nations agencies for their
global Hepatitis-immunisation programmes. He disclosed that UNICEF
had issued a letter of intent to purchase 8.5 million doses of Shanvac
B vaccine during 2002-2003. The order is worth around US $5 million.
Shantha
becomes the seventh company in the world to get the WHO certification
for hepatitis-B vaccine, he said.
Under
a two-year pilot programme, the Global Alliance for Vaccine Initiative
(GAVI) will be procuring 2 million doses of hepatitis-B vaccine
of WHO certification for its immunisation programme in India. The
WHO certification for Shantha has come at an appropriate time, Khalil
said. He recalled that when Andhra Pradesh’s hepatitis-B immunisation
programme, funded by the Bill and Melinda Gates Foundation, was
initiated in six districts of the state last year, the Foundation
was forced to import the vaccines from South Korea by paying heavy
customs duty because no Indian company had WHO certification then.
He
said the response to the company’s Alpha Interferon was good.
Shantha has launched this anti-cancer drug in select markets in
India. It will soon be available in all parts of the country, he
said. Shantha will be launching Streptokinase in another four months.
At present it is undergoing clinical trials at Hyderabad, Mumbai,
Chandigarh and two other places. Human insulin would be launched
in the last quarter of this financial year, the executive director
of the company added.
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