`Our strength lies in our large human resource'

From a traditional biological approach to state-of-the-art biotechnology, India has indeed come a long way in the last two decades, thanks to the wide-ranging initiatives taken by the Department of Biotechnology (DBT). Dr. Manju Sharma, Secretary to the DBT, highlighted the achievements of the department and detailed the new initiatives planned to promote biotechnology for societal improvement, in an interview to B.S. Padmanabhan. Excerpts:

How would you sum up the changes brought about by the National Biotechnology Board (NBTB) and its successor, the Department of Biotechnology, over the past 20 years?

The DBT was established in 1986, prior to which we had the NBTB. Biological research at that time was conducted basically under the auspices of the DST (Department of Science and Technology), the CSIR (Council of Scientific and Industrial Research), the ICMR (Indian Council of Medical Research), the ICAR (Indian Council of Agricultural Research) and some other agencies. In 1982, a large number of experts, under the auspices of the Science Advisory Committee to Cabinet, discussed the developments in modern biology; the world had recognised the significance of biotechnology. It was felt that India must consolidate its efforts and give a new direction to research in modern biology with a new institutional framework. The NBTB began to focus on human resource development, creation of infrastructure and support to some R&D projects. This was done on a very small scale with the association of several scientific agencies. The HRD programme took off well; projects supported under R&D were more oriented towards product and process development. It was felt that it was too small an effort and by 1986 it was recognised that the full potential of biotechnology needed to be realised. The DBT was set up with a specific mandate. India can be proud of the fact that it is the first country to establish an independent department of biotechnology.

The initial three or four years were spent in creating the necessary infrastructure and establishing connectivity through the application of bioinformatics, and support to some R&D projects. The DBT identified the thrust areas in which biotechnological interventions were required. We involved the scientific community with specific expertise in various fields. Taking note of the phenomenal advances in biotechnology the world over, we decided at the very outset that we should take advantage of non-resident Indian scientists. We set up the Standing Advisory Committee-Overseas (SAC-O), consisting of eminent NRI scientists. It was a unique experiment. This committee met once a year and played a significant role, particularly in the development of the HRD programme and in the training of Indian scientists in foreign countries. The DBT has established many institutions. The National Institute of Immunology (NII) was the only one set up by the NBTB but it became fully operational under the DBT. The first vaccine, now an immunomodulator and recognised as "orphan drug", was developed at the NII. Then we set up the National Facility for Animal Cell and Tissue Culture in Pune. This was later designated as the National Centre for Cell Science. Today it is one of the best research centres in cell biology. Then we went ahead with the setting up of the Centre for DNA Fingerprinting and Diagnostics in Hyderabad, the National Brain Research Centre in Gurgaon, the National Centre for Plant Genome Research in New Delhi and the Institute of Bioresources for Sustainable Development in Imphal. Recently, we took over the Institute of Life Sciences in Bhubaneswar. In addition, we supported the New Delhi component of the International Centre for Genetic Engineering and Biotechnology, which has an independent administration governed by United Nations Rules. It has established linkages with national laboratories and has taken up joint projects in a number of areas. Another initiative taken in the public sector was the establishment of the Bharat Immunologicals and Biologicals Corporation.

Initially, while we were creating centres of excellence, we decided to set up major facilities to cater to some of our specific requirements in biotechnological R&D. The plant tissue culture pilot plants at the NCL (National Chemical Laboratory), Pune, and TERI (Tata Energy Research Institute), New Delhi, have been producing more than two million plantlets a year. During the past five years, 51 technologies - ranging from tissue culture plants to biofertilizers, biopesticides, diagnostics and therapeutic products - have been transferred for commercial use. One of them worth mentioning, which has captured 90 per cent of the market, is the Western Blot HIV (human immunodeficiency virus) detection kit. The kit was developed under a small project at the Cancer Research Institute, Mumbai. There are a number of such success stories. One is the development of anti-leprosy immunomodulator, which is being exported and is recognised by the United States Food and Drug Administration as the first Indian "orphan" drug. Very soon you will see other important uses of this product.

In the field of basic research we have done very well. The Indian Institute of Science, Bangalore, under programme support, has more than 200 publications in national and international journals, having a significant impact factor. Our scientists are regarded on a par with global experts in some areas and are even members of international advisory committees.

Keeping pace with international research on transgenics, a number of crops have been taken up for improvement with this technology. The work on GM (genetically modified) potato is significant. We try and take the research leads to their logical conclusion and the result is increased hybrid vigour in potato with improved protein content. Owing to increased productivity in yield, it is expected that once the variety is cleared for use, farmers will have more income. The field trials were done in close collaboration with the ICAR, and the Central Potato Research Institute in Shimla is conducting the trials. There is also a need to improve the quality of pulses. We have started work on chickpea. The projects on rice and wheat have progressed well. In the agricultural area we have been very selective. We have identified rice, wheat, mustard and pulses as priority crops for research. Tissue culture has really got a boost from DBT-supported programmes. In order to tap the export potential of tissue culture, we have decided to set up a national consortium of tissue culture plant producers. The Agriculture Ministry has now agreed to all terms and conditions to issue certificates to growers that the material is virus-free so that it will facilitate export. A national virus-testing facility has been established.

Our achievement in rice genome sequencing has brought India into the international field in this area. We expect a major initiative in the functional genomics of rice. One more initiative we have taken is in the area of bioprospecting for new molecules. This is a joint project with the Department of Space. A database called BIOSPEC has been released and has got an international prize.

Our programmes for societal development have benefited about 60,000 families and the 16 genetic counselling units have benefited 19,000 tribal families. The DBT programmes have helped in environmental improvement, especially reclamation of mine spoil dumps and use of oil-zapper for the treatment of oil spill. We have taken up a number of new initiatives to develop various vaccines.

Despite the DBT's commitment and the progress made so far, there is a feeling that the biotech industry, which is in its nascent stage, requires more initiatives on the part of the government to enable India to join the elite club of bio-cluster countries. What in your opinion are our strengths and weaknesses in this area?

If you look at the ASEAN (Association of South East Asian Nations) countries, India is progressing very well. Our infrastructure and R&D are regarded as our strength. It is for that reason that we have been identified to organise the Biotechnology Network for the ASEAN region.

About the weaknesses, I feel we have to bring in a lot more of private investment. Government investment in the Ninth Plan in this sector was Rs.622 crores and this has been more than doubled to Rs.1,450 crores in the Tenth Plan. In the U.S., private investment accounts for 80 per cent and the government contributes only 20 per cent. In India if private investment is increased to at least 50 to 60 per cent, it will transform the entire sector. The consumption of biotechnology products in India in 1999 was worth $1.78 billion. By 2010 this is projected to increase to $4.27 billion. The number of biotech companies has risen from two to 35 over the past five years, especially in the rDNA biopharmaceutical products. In addition, we have around 10 companies in agricultural biotechnology. There are at least 45 companies engaged in modern biotechnology. More than 900 companies are involved in traditional biotech products.

The multiplicity of regulators is cited by the industry as a hurdle. What is your comment on this?

Every country has more than one regulatory agency covering biotech products. The biotech sector consists of several areas and one body cannot clear everything. Luckily under the Environment Protection Act we can look at all the aspects. Thanks to the efforts made by the DBT, there is now an advisory committee for the Drug Controller of India for recombinant products. This has facilitated approvals for drug products and reduced the time taken for approvals. Evolving biosafety protocols is a continuous process. We have mechanisms for speeding up clearances, especially for foreign direct investment involving Rs.100 crores or more as per FIIA guidelines.

What about the concern over International Patent Rights issues?

It is a national policy issue. There is no point in my saying anything. The nodal Ministry for IPR is the Department of Industrial Policy and Promotion in the Commerce and Industry Ministry. As far as biotechnology is concerned, we have given all our inputs in terms of what can be done, like how to define microbiology, how to define microbial processes, whether we should go in for patenting of genes or life forms and so on. For the first time in the country the DBT has introduced a course on IPR in Biotechnology at the National Law School University, Bangalore. It has been well received.

There is a feeling that the lack of a national policy is a constraint to faster development of this sector. What is your view?

We now have a Science and Technology Policy and it covers everything, including biotechnology. We are very well covered and there is no need for a separate policy for biotechnology. The Department of Space does not have a separate policy. We all work under the framework of the National S&T Policy. But on certain specific aspects there is a need to have a separate framework as in the case of transgenics. We are in the process of finalising a policy paper on GM food. Another major policy initiative is to become a signatory to the Budapest Treaty. We have started an International Depository Authority in Chandigarh, open to all countries. By becoming a member of the Budapest Treaty we now have access to materials from other countries.

The industry-institution linkage is said to be weak and this is cited as one of the hurdles faced in the promotion of this sector. What is your comment?

We are trying our best to improve the linkage. As you know we have set up the BCIL (Biotech Consortium India Limited) olonly for this. It is a gradual process. But I would say that our department has a significant interaction with academia and industry in terms of scientists-to-scientists and scientists-industry interaction. We have introduced industrial training programmes in IIT-Delhi and UDCT (University Department of Chmeical Technology), Mumbai. These have been producing a large number of students every year and most of them have jobs ready for them. Our own HRD programme has been a great success in developing the biotechnology sector. Sixty-eight teaching courses are being run and a strong post-doctoral programme has been supported. We have opened a course on environmental biotechnology. We are introducing Ph.D. fellowships too. I want to get more and more Ph.Ds in biotechnology. We want to introduce more fellowship programmes. The number of student fellowships has increased from 10 to 25 and we want to raise it to 50 during the 10th Plan period. Biotechnology-based programmes for society are going to get high priority. The Budget allocation has been doubled for this.

How do you visualise the future of this sector?

The global estimate is that biotech revenues will increase by 15 per cent and R&D will increase by 34 per cent by 2010. We expect that in India the biotech situation in the next five years will change significantly. The FDI in this sector during 1999-2002 amounted to Rs.147.75 crores. It is a substantial increase compared to previous years. Last year it was the highest in Uttar Pradesh. We have a Fast Track Committee to clear FDI proposals so that more industries can come up. I visualise that in the next five years while the government will continue to support research, many research leads will get into product mode. The biotech industry will witness significant, if not phenomenal, progress in the next five years following the world trend. India is also moving fast towards becoming a major player in the field of biotechnology. The number of international agreements has risen from two in 1986 to about 25 at present. Biotechnology holds enormous potential for national development, especially towards an environmentally sustainable approach.