The Hyderabad-based Indian Immunologicals Limited (IIL) is planning to launch the recombinant human Hepatitis vaccine during 2005. In the 44th meeting of the Genetic Engineering Approval Committee (GEAC), IIL has received the approval for conducting phase III clinical trials of r-human Hepatitis vaccine.
The company has already set up a human vaccines facility and an R & D unit with an investment of Rs 50 crore. The plant has been designed to manufacture various human vaccines such as Recombinant Hepatitis B, Measles, Diphtheria, Pertussis and Tetanus. In addition, the plant has the capability and technology to produce new combination vaccines. This complex houses several plants, which can simultaneously manufacture 200 million doses of each vaccine per annum.
Apart from catering to the national needs, the vaccines produced in this plant will also be exported to meet the growing demand for quality vaccines under UNICEF's vaccine procurement programme.
The R & D centre has been set up with an investment of Rs 8 crore. The centre will develop various animal and human vaccines and biologicals. Indian Immunologicals will undertake research, which will lead to production of not only low cost but also thermostable products.
The research centre will focus not only on developing vaccines based on modern biotechnology, but will also work towards developing therapeutics and diagnostic agents based on molecular biology. An important area of IIL's research will be an area of Hybridoma and Human monoclonal antibodies for therapeutic purposes.
It is significant to note that GEAC has also approved Shantha Biotechnics (Hyderabad) to conduct phase III clinical trials of r-Hepatitis B Combination Vaccine (DTPw). Global Human Vaccine segment is about USD 6 billion (about 2 per cent of Global Pharma market), growing at about 10 per cent per annum and is likely to be USD 10 Billion by the turn of the decade.