Pune-based Serum Institute will commence exports of its Hepatitis B vaccine {HBV} by August after getting the approval from WHO. The approval is expected any time from now. "We have filed the relevant applications with the WHO. The WHO team has already inspected and is satisfied with our plant. Ideally from August onwards, we should begin our first batch of exports," said Masud Ahmed, Marketing Director, Serum Institute.

The company is also in the process of awaiting export approvals for HBV from other institutions like Unicef and Gavi.

The WHO will be awarding annual tenders to Serum Institute, which could be renewed at the end of a year. Serum Institute already has a wide network of distribution and marketing agencies across Africa, Middle East, South East Asia, Europe, and South America.

Serum Institute manufactures its HBV at its Pune-based plant with a capacity to manufacture 100 million doses. Only a part of the current capacity is utilized for the manufacture of the vaccine, which is then domestically distributed. "The current capacity will be sufficient to meet the demand from exports. However, in future we consider to expand the capacity," said Ahmed. Serum Institute sells the least expensive HBV in the country today. Domestically a 10 ml vial of Serum's HBV Genevac-B costs Rs 875, while the pediatric single dose of 0.5 ml costs Rs 55.

Serum Institute manufactures HBV at its Pune plant by recombinant process from the yeast Hansenula polymorpha. Germany's Rhein Biotech has licensed the technology to the company.

The HBV market in the country is estimated at Rs. 300 crore. "HBV overseas should be controlling a market of more than Rs 10 billion," said a pharma analyst at a Mumbai-based equity research outfit.

Currently only few companies like Wockhardt, Shantha Biotech, Bharat Biotech, Panacea Biotech and Zydus Cadila manufacture HBV in the country. Most of these companies already export these vaccines. However, these exports are predominantly to the under developed and the developing regions of the world on institutional basis.