The Hyderabad-based public sector pharmaceutical company Indian Immunologicals Ltd (IIL) will soon introduce indigenously manufactured anti-rabies DNA vaccine in the country. The IIL is waiting for the green signal from the Indian drug regulator Drug Controller General of India (DCGI) to whom the company had filed the product dossier including clinical trial reports and other data.

IIL, the wholly owned subsidiary of National Dairy Development Board, is the first firm in India, either from public or private sector, to produce and market DNA rabies vaccine in the country, Dr G S Reddy, chief general manger of the company told Pharmabiz. Once the license is received, the company will foray into domestic marketing.

In the initial stage, the vaccine will be used for animals only. The major advantage of the vaccine is the prolonged duration of immunity so that it would be able to replace the conventional cell culture rabies vaccine. This development is the result of a collaborative effort of Indian Institute of Science, Bangalore, National Institute of Nutrition, Hyderabad and Indian Immunologicals, Dr Reddy added.

Regarding another advantage of the new product, Dr Reddy said DNA rabies vaccine could withstand accidental exposure to higher temperatures or cold chain failure in the field conditions. To a query he said the price of the medicine would be marginally lower when compared to traditional vaccines as it can be produced at less cost. It was only a decade ago that scientists of the Institute found that bare strips of DNA could act as a vaccine.

Plasmid DNA coding for the Glycoprotein fragment of rabies virus is purified from E.coli and used as an active ingredient in formulating DNA rabies vaccine. The R&D work was performed in the Indian Institute of Science, Bangalore and the Pre-clinical toxicology testing was done at the National Institute of Nutrition, Hyderabad, he said.

For the time being, the company will market the product only in India, but possibilities for exports will be explored in future, he added.

In India, according to some statistical data, about 30,000 people die of rabies each year while another 500,000 take preventive injections.