With overall global supplies of anti-hepatitis B (HB) vaccine to World Health Organisation are far exceeding the demand, some of the traditional suppliers of this vaccine including Serum Institute of India are getting hit. According to an estimate, about 39 crore doses is the current demand from WHO on an annual basis. As more new players are getting added to the list of bulk HB vaccine suppliers to WHO, the overall supplies are exceeding the demand.

"As more quality players of late from Korea, Europe, South America and South East Asia are showing interest towards supplying vaccines to WHO, the emerging competition is hitting Indian supply of vaccines to WHO," said Dr. Suresh S. Jadhav, Executive Director, Serum Institute of India.

In March senior officials of the company had told Pharmabiz.com about inspection from WHO authorities at the company's sites. They were also confident about beginning exports to WHO from August 2003. However, the company somehow missed the contract. The WHO has already booked its suppliers for the years 2004, 2005 and 2006. Nevertheless, Serum's name is not included in the list, said sources.

The current domestic market for HB vaccines is seven crore doses and the global of 39 crore doses. Citing a huge demand from overseas, the company has already set up a manufacturing facility of 15 crore doses (38 per cent of the current global capacity).

However, on account of the reduced demand the company is now clearly underutilizing its capacity.

Despite all this, the export chances of the company have not been totally underplayed as it has started HB vaccine exports to several countries on an individual basis, said Dr. Jadhav. He however refused to disclose the names of these countries.

Serum Institute manufactures its HBV at its Pune-based plant. It 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.

Currently only few companies like Wockhardt, Shantha Biotech, Bharat Biotech, Panacea Biotech and Zydus Cadila manufacture HBV in the country. On account of stiff competition the margins from the sale of a vaccine is nearly flat. This has made a company like Pfizer to pull out of marketing tie up with Shantha Biotech for the latter's HB vaccine Shanvac-B.