Under the New Millennium Indian Technology Leadership Initiative (NMITLI) project launched by CSIR, Mumbai-based Lupin laboratories Ltd, partnering with four institutions, has discovered a new anti-tubercular molecule for the treatment of tuberculosis. This is the first success achieved in developing a new therapeutic molecule for tuberculosis since the last discovery of rifampicin in 1963.
The molecule, works through combination therapy (compatible with the present drugs), is less toxic and further there is no recurrence of disease observed. It fits well into the present four-drug therapy by replacing one or two drugs from the (present) cocktail.
Regulatory studies on new pharmacophore have been completed and an Investigational New Drug (IND) application has been filed. Once the IND is cleared by the Drugs Controller General of India (DCGI), the molecule will undergo phase I, II and III clinical trials in human subjects. These trials are expected to take about 4 to 5 years, and if they are successful, the new drug will be introduced into the market.
CSIR, through the New Millennium Indian Technology Leadership Initiative (NMITLI) scheme, supported a project entitled "Latent M. tuberculosis: New targets, drug delivery systems and bio-enhancers and therapeutics" in the year 2001. The objectives of the project are to improve current treatment by shortening total duration of treatment and address the problems of Multi Drug Resistance (MDR) and latent tuberculosis infection.
In order to achieve these objectives, a three-pronged strategy was employed viz. development of new drugs including identification of new targets, new drug delivery systems and application of bio-enhancers as an adjunct to chemotherapy. A network of 11 leading research institutions and Lupin as industrial partner in 'Public-Private Partnership' mode was put in place to achieve the objectives of the project.
The institutional partners are International Centre for Genetic Engineering and Biotecnology (ICGEB), New Delhi; Bose Institute (BI), Kolkata; Central Drug Research Institute (CDRI), Lucknow; Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad; Indian Institute of Chemical Technology (IICT), Hyderabad; Indian Institute of Science (IISc), Bangalore; Institute of Genomics and Integrative Biology (IGIB), New Delhi; National Chemical Laboratory (NCL), Pune; National Institute of Immunology (NII), New Delhi; and Regional Research Laboratory (RRL), Jammu; University of Hyderabad, Hyderabad.
As per the WHO (2000) report, two billion people are infected with tuberculosis worldwide. Nearly, 8 million new cases are added annually and the biggest burden is in South East Asia. Around 3 million deaths due to tuberculosis are reported every year and India accounts for around 0.5 million deaths. With the rampant Human Immunodeficiency Virus (HIV), TB disease has acquired the severity of epidemic proportions.
Current market for anti TB drugs is estimated at $ 600 million per year. Tuberculosis is said to be a poor man's disease with low per capita income. Low returns is said to be the reason behind multi national drug companies' luke warm attitude in tuberculosis research.