Dr R A Mashelkar, director-general of Council of Scientific & Indus-trial Research, is a scientist with rare leadership ualities. He has had a major role in attuning India''s publicly fun-ded research & development (R&D) institutes to the demands of globalization. Mashelkar believes in changing his priorities in order to promote economic growth of the country. Thanks to a transformation of culture due to him, the CSIR laboratories are no longer apologetic of stating their commercial goals. Being the secretary, department of scientific & industrial research, Mashelkar is in a position to decide his policies too. In an interview with K G Narendranath of Chronicle Pharmabiz, Dr. Mashelkar avers his commitment to the entrepreneur. Excerpts:

The decoding of the human genome has provided the global scientific community with valuable information. How poised are Indian institutes and industry to pick up the threads and do subsequent research on genes?
With the unfurling of the human genome, India is uniquely placed to take up further studies that would ultimately lead to gene-based drugs. With its abundant genetic diversity (1,000 million people, 3,000 communities, 80,000 units of identity and 28,000 endogenous groups), India has a vast genotyped clinical base that would facilitate understanding of genes. The identification of disease-predisposing genes is an important area in the work towards gene-based medicines.

On genomics, CSIR''s action plan includes entering to alliances with leading pharmaceutical companies in specific areas of research, in a way that the exclusivity of one project would not overlap with another. The alliance between the Centre for Biochemical Technology and Nicholas Piramal India Ltd --- Genomed - is the first major venture in this regard. The project is unique in the sense that here you see the government supporting the industry with the initial infrastructure and a facility being set up in the government with the support of the industry.

The department of biotechnology and the CBT gives initial infrastructure support for Genomed. NPIL has already invested Rs 8 crore in the project, which aims to develop gene-based drugs for schizophrenia, asthma and diabetes. Other initiatives on genomics and related areas include the joint project between Centre for Cellular & Molecular Biology (CCMB), Hyderabad and Biological Evans. Besides, CCMB has a project in bio-informatics with Satyam Computers.

Apart from the vast genotyped clinical base, which even the multinational companies are keen to use, information technology (IT) skills and biosciences expertise will facilitate India''s way in the post-genome coding research.

The genome projects being planned by CSIR in this background will therefore aim to develop genomic medicines for cancer, diabetes, arthritis and cardiovascular disorder. There will also be action in the area of molecular diagnosis of common genetic disorders.

Biotechnology, with its tools like the recombinant technology, has emerged as a path-breaking domain in new drug research with its capability to produce highly effective, non-toxic therapeutic proteins to treat diseases like cancer. Has CSIR got any concrete plan in this field?
We are already into biotechnology and recombinant technology with many of the laboratories working in diverse areas of biotechnology and its applications. We collaborate with the department of biotechnology for specific projects. I''m happy to inform you that an r-DNA product from CSIR is already in phase2 clinical trials in the country. This, a potential cholera vaccine, is being jointly developed by three institutes-the Institute of Microbial Technology, Chandigarh, the IICB and the National Institute of Enteric & Communicable Diseases, Calcutta.

What are the possibilities you see in India regarding industry-government collaborative functions in biotechnology research? Comment on the prospect of Indian biotech companies engaged in new drug research?
It is heartening to note that a buzz of activity is now seen in the biotechnology sector in the country thanks to a group of entrepreneurs with technological background.There are a few domestic companies quite enthusiastic about doing genuine technological research. I would laud the efforts of companies like Shantha Biotechnics, Bharat Biotech, Biological Evans, and Biocon etc. who are leading a biotech revolution in the area of drug discovery. Entrepreneurs who have technological backgrounds manage these companies. I would want a hundred more such "technopreneurs" to come up in the country in the nest few years to make the biotech revolution a distinct possibility. The government has a commitment to support them with technological inputs and by providing infrastructure.

The Biotechnology Parks being planned in many states are expected to provide a hassle-free environment for entrepreneurs in biotech sector. The ICICI Knowledge Park in Hyderabad is pioneering accomplishment on this front. More such parks are in the process of being set up in the e country with many state governments showing active interest in these projects. Biotechnology Parks are being built in states like Madhya Pradesh, Maharashtra, Gujarat, Andhra Pradesh, Tamil Nadu, Kerala and Orissa. I now see the chief ministers of these states acting as CEOs with each state trying to market its niche capability and healthy inter-state competition emerging. These units in these parks should be given concessions on fiscal front and the governments could assist them to obtain the lands.

With globalization of R&D, adherence to Good Laboratory Practices (GLP) has become a must. What are the steps taken to upgrade the quality and procedural correctness of various CSIR laboratories?
We have invested Rs 250 crore in the last four years to modernize the laboratories in accordance with the GLP guidelines. Sophisticated equipment for rapid throughput screening, combinatorial chemistry and bio-informatics has been installed in many laboratories. The process of modernization is on.Herbal therapeutics is one-area CSIR laboratories have already delivered some final products. Comment on the progress made in this segment. On the herbal segment, we have another major project that mobilizes the strengths of 19 CSIR laboratories in different areas of herbal drug development.

The project involves a networked endeavour to utilize and enhance the skills, knowledge and expertise of various laboratories in areas such as collection of plants, isolation of active compounds, elucidation of their structures, formulation, toxicology, animal tests and clinical trials.

The finance ministry has already made an outlay of Rs. 47 crore for the project. Besides isolation of bioactive compounds from plant extracts, the project will also try to discover new therapeutic applications of known preparations.

The project gives thrust on development and validation of drugs for 20 diseases that are important in Indian context including diabetes, ulcer, asthma and TB.Already, 17 patent applications have been filed on bioactive leads developed under the project.