IIL Gets Govt Nod For Clinical Trials On Hepatitis-B Vaccine

Hyderabad | Updated: Jul 28 2004, 04:35am hrs
Indian Immunologicals Ltd (IIL), a wholly-owned subsidiary of the National Dairy Development Board (NDDB), is upbeat on recombinant vaccine products. The company has received an approval from the Genetic Engineering Approval Committee (GEAC) for conducting phase-3 clinical trials for human recombinant Hepatitis-B vaccine.

IIL chief executive officer KV Balasubramaniam said, Having received the approval, we will be launching the recombinant human Hepatitis vaccine sometime during the first-half of 2005. Further, we are also planning to release the doses for Hepatitis-A during the year 2006, he added.

As part of this effort, we have already set up a human vaccines plant and an R&D centre at a cost of Rs 50 crore in Hyderabad, Mr Balasubra-maniam told eFE. The proposed new plant has been designed to manufacture various vaccines such as recombinant Hepatitis-B, Hepatitis-A, measles, diphtheria, pertussis and tetanus besides making combination vaccines in future. The plant, to be set up with an investment of Rs 42 crores, has a capacity to produce about 200 million doses per annum of each vaccine.

The remaining Rs 8 crore is being invested for the R&D centre to develop various animal and human vaccines and biologicals, besides engaging in development of various recombinant products using prokaryotic and eukaryotic vectors.

Meanwhile, IIL is also developing the first indigenously DNA-based vaccines for rabies. The company proposes to launch these veterinary vaccines during the next year. The project is being developed in association with the Indian Institute of Science, Bangalore and the governments department of biotechnology (DBT).

For the first time in the country, a thermostable vaccine is indigeneously manufactured and will be made available in the country, he said. On the need for these kind of vaccines, Mr Balasubramaniam said that they are relatively cheaper than the existing cell-cultured vaccines and the cost is about half of the existing vaccines.

According to estimates, the current size of the global human vaccine market is about $6 billion and is growing at about nine per cent annually. This is expected to touch $10 billion by 2010, with a possibility of going up further.

The company is strengthening its R&D efforts for recombinant vaccines and hopes to have at least two per cent market share for veterinary and combination vaccines in the global market.