Hyderabad: Bharat Biotech International Ltd, Hyderabad, which launched rDNA based Hepatitis vaccine with indigenous technology in January 1999, sold around one million doses of the vaccine worth around Rs 3.8 crore in the first three months of this year. In June alone the company sold five lakh doses of the vaccine and recorded a growth rate of 40 per cent in sales. It made a net profit of around Rs 75 lakh.

The Rs 15 crore modern vaccine plant, which is located at Turkapalli in Ranga Reddy district, has a capacity to produce 75 million doses per annum. The company at present is producing a capacity utilisation of nine million doses per annum, says Dr Krishna M Ella, chairman and managing director of Bharat Biotech.

Speaking to Express Pharma Pulse, Dr Krishna said the company was directly dealing with doctors for promoting the sales of the vaccine. It has entered into a tie-up with Intas Ltd for marketing the vaccine in northern and other parts of India, including Kerala. In the sates of Tamil Nadu, Andhra Pradesh and Karnataka, the company itself has undertaken the task of marketing the product. "In Tamil Nadu and Bangalore we are most respected as an ethical firm," he said.

He said the commitment to ethics was behind Bharat Biotech's distinction as the only company in India and the fourth in the world to use the technology approved by the US FDA for the production of Hepatitis B vaccine under the brand Revac-B.

Dr Krishna said the company's advanced research and manufacturing facility, equipment, procedures and practices met the requirements laid down by the US FDA, UK MCA and WHO. "Ours is the only firm to get three major R&D grants amounting to Rs 4.2 crore," he said.

It may be recalled that the company has understanding with two reowned scientific institutions - the Indian Institute of Science, Bangalore for joint research programme and the University of Wisconsin Madison, USA, for ratifying the quality of the products developed through numerous testing methodologies and certifying the results.

Dr Krishna said, "In biotechnology we have to go slow because of the involvement of quality. Quality has to be built into the product at every stage. There is no way it can be added at the end. Nearly 35 per cent of the company's production cost goes for quality control."

The company is planning to export its vaccine to the Middle East, Sri Lanka and Bangladesh by end 1999.

On future plans, Dr Krishna said the company had developed streptokinase, a drug to treat heart ailment, and the product at present was undergoing animal trials in a research institute. After clinical trials, this product which is at present imported is expected to be launched in January 2000. The company is also working on producing human insulin with the indigenous technology. "We want to take this project as a technology challenge," he said. All the new products will undergo the same rigorous quality, efficacy and safety testing methodologies at Bharat Biotech's available scientific facilities.

On the entry of new players like Cadila and Wockhardt into the Hepatitis-B market, the chairman and managing director of the company said, "Competition will only benefit the consumers and improve the quality of the product. We welcome healthy competition and the market will expand."