The Central Government has taken an in-principle decision to earmark Rs 150 crore as budgetary allocation every year to the Pharmaceutical Research and Development Support Fund (PRDSF) for promoting drugs R&D. The allocation would see an end to the current practice of having Rs 150 crore as corpus amount, the interest of which (to the tune of Rs 25 crore) can only be really made available for research development purposes.
Announcing this at a press conference, Kapil Sibal, Minister of Science and Technology said that the changes would be reflected in the Union Budget 2005-'06. The minister also informed that the United Progressive Government has decided to simplify the rules for import of laboratory animals meant carrying out clinical trials. "A Group has been formed to look into the matter and the problems faced by the research organizations in animal experimentation would be solved very soon," he said. "India is to be the clinical hub of future. The import of large animals for drug research will never be a problem," he assured.
The press conference was organized to announce the scientific breakthrough achieved by Indian scientists in developing a highly potential anti-TB drug candidate that is likely to reduce the duration of the treatment by one forth. The drug candidate which has cleared the animal trials and is about to enter Phase I clinical trials soon is expected to address the problems of multi drug resistance and latent tuberculosis infection.
Announcing the scientific breakthrough, the minister felt that the enhancement of PRDSF would certainly help the cause of drug R & D for diseases of the developing world.
The discovery was made possible through the New Millennium Indian Technology Leadership Initiative (NMITLI) project launched by the Council of Industrial and Scientific Research (CSIR). The industrial partner of the project is Lupin Limited.
According to Dr R A Mashelkar, director general CSIR, this is the first success achieved in developing a new therapeutic molecule for TB since the last discovery of rifampicin in 1963. The molecule works through combination therapy (compatible with the present drugs), is less toxic and is believed to prevent re-occurrence of the disease. Lupin has filed an Investigational New Drug Application with the Drugs Controller General of India (DCGI) on August 13, 2004 and is getting ready to start clinical trials post DCGI approval.
A network of 11 leading research institutions that comes under the CSIR stable and Lupin had joined together in "Public Private Partnership" mode to achieve the objectives of the project.
D B Gupta, chairman, Lupin, Yogeshwar Rao, Director CSIR and S K Arora, president, Lupin Research Lab were also present at the press conference.