says DBT secretary Dr Manju Sharma in an exclusive interview with N Suresh, Biospectrum. Excerpts:

Q. Which are the thrust areas of research in biotechnology in India supported/ encouraged by DBT? Why ?

A. The Department of Biotechnology is supporting R&D activities in the areas of agriculture, healthcare, environment and industry. Basic research in new biology and biotechnology, genomics-structural and functional, drug designing, drug targeting, vaccine development, bioresource utilization and development and bioprocess development are some of the major thrust areas. The areas identified for support are based on the national leads and keeping in view the vast bioresources available in the country. Biotechnology programs for societal benefit have also been supported targeting the population in the rural areas particularly the women, SC/ST and weaker sections. 

Q. How many gene based vaccines are now ready for use by people in India ?

A. Under a Jai Vigyan National Mission program, studies have been taken up for generation of vaccines for six major diseases -- Rabies, Cholera, HIV/AIDS, Malaria, Tuberculosis, JEV. The status of the vaccines is as follows :

Rabies--Ready for commercial use in animals; approvals awaited.

Cholera --Phase-IIA Clinical trials.

HIV, Malaria, Tuberculosis, JEV - Pre-clinical evaluation for toxicity and immunogenicity.

Q. India is now looked upon a major area of activity by the global biotechnology segment? Which areas would governments encourage foreign collaborations in both scientific and industrial segments ?

A. There is a major thrust on both bilateral and multi collaborations with countries across the world and special cooperation programs have been initiated for countries of the South East Region, ASEAN, SAARC, G-15 etc. Programs in the areas of plants and agriculture, genomics, vaccine research, bioinformatics, process engineering etc., have been given high priority. Human resource development, capacity building and training of young scientists in the advanced areas of biotechnological research is also a priority. Joint Centres for Biotechnology have been supported under the Indo-Russian and Indo-ASEAN programme. Collaborations with US in the area of vaccine and contraception research have been very successful. 

Q Has DBT fulfilled the mandate for which it was set up in 1986? What strategic and tactical changes have been made to respond to the fast changing developments in Biotechnology ?

A. The Department of Biotechnology was set up in 1986 with a mandate to support research and development, technology demonstration and validation, establishing Centres of Excellence, capacity building and also to address important Policy issues related to biosafety, IPR etc. The department has been successful in fulfilling these objectives and with 15 years of support nearly 50 technologies have been transferred to the industry for commercialization in the areas of agriculture, healthcare and environment. 

A large number of diagnostic kits have been transferred to the industry and a number of gene based vaccines are now in the final stage of development. In the area of agriculture, transgenic crop production, high quality planting material through tissue culture and important herbal products are some of the major achievements. Products of biofertilizer, mycorrhizae etc., are also today being widely used across the country and their benefits in the farmers field are visible.

A very good regulatory and biosafety system is in place. Recombinant DNA and Biosafety guidelines formulated by the department have been widely distributed and are today adopted by the whole country. Guidelines for Clinical trials, Ethical guidelines for Human Genetics have also been formulated and have now been adopted. The department has played an important role in promoting the industrialization of biotechnology and in an effort in this direction the procedures have been simplified and a single window clearance is now provided. World over there is now a recognition that developing countries will increasingly depend more and more on Biotech research and its application. India is well poised for this.

Q. The Human Resources Development program with the common entrance tests and stringent admission criteria has been a great success. Are more such programs in the pipeline to cater to the growing need for biotech professionals in the research and industry ?

A. The Human Resources Development programme has been expanded exponentially and more than 64 universities have now been supported. A large number of specialized M.Sc. programs in the areas of agriculture, nuero sciences etc., have been supported. There is also a thrust on industrial training which is provided to post M.Sc. students. The post doctorate programme has been restructured and 150 scholarships are provided. Specialized training programs are also being supported.

Q. The private sector is now emerging in biotechnology in both research and commercialization sector. What is the government policy to encourage the greater involvement and emergence of a vibrant industry similar to the software industry ? 

A. The policy of the government with regard to research and technology development for commercialization and incentives for the industry have also been indicated under Point No:4.

Q. There is a big competition between various states in announcing a Biotechnology Policy and also in attracting investors with fiscal and other concessions. Do these efforts mesh into the national framework of biotech policy ? 

A. A ‘Biotechnology Vision document’ giving a Ten Year Perspective is available. This document was released by the Hon’ble Prime Minister and has thereafter been circulated by the Minister for S&T to the Chief Minister’s of all states and union territories. The response has been very positive and each state has developed or is in the process of developing its own Biotechnology Action Plan. The framework of activities has already been announced by few states like Tamil Nadu, Andhra, West Bengal, Haryana, Himachal Pradesh, Kerala etc. Other states like Rajasthan, Orissa, Madhya Pradesh, Gujrat etc., are in the process of developing their own framework. 

The State Action Plans have been prepared in close consultation with the department and are in line with the National Biotechnology Vision formulated by DBT. The programmes have been formulated in a need based manner depending up on the priorities of the State. The emphasis is mostly on setting up of a biotechnology bark or a rural biotechnology village as the case may be, mainly for taking up the biotechnology leads for benefit of the society through both industrial and ground level activities.

Q. There is a clamor among the biotech community that this is the right time to evolve a National Biotech Policy similar to the national policies on defence, atomic energy, space and telecommunications so that a consensus exists on various issues. Also they feel this will help the industry get on with the work on hand and avoid some of the delays in the regulatory process. Is there a need for such a national biotechnology policy now ? Is there a plan to announce a separate Bioinformatics Policy to leverage India’s expertise in computer software segment ?

A. The Biotechnology Vision document conveys the importance of the department for National Biotechnology Program. This fits into the over all Science & Technology Policy released by the Prime Minister on 3 January 2003. There is no requirement for a separate Biotech Policy. However issues such as ethical, biosafety, monitoring, societal aspects etc., have been addressed.

The department has a very strong Bioinformatics Network programme in the country with 60 Centres. A Virtual Private Network (VPN) is also established to link some of the major institutes. Under a Jai Vigyan Mission programme Mirror sites for database were supported in four institutes. A specialized diploma in bioinformatics has also supported in some universities. This vast network is being widely used by the scientific and research community in the country. Details of the programmes and future priorities form a part of the Biotechnology Vision document.

Q. How is the regulatory process in India compared to that in many developed and developing countries? Are there any gaps in the regulatory process related to biotechnology. If yes, are they going to be filled up soon ?

As mentioned in Point No: 4 the department has formulated exhaustive guidelines for biotechnology research in the areas of biosafety, clinical trials and human genetics. For the transgenic and recombinant research there is a well structured regulatory framework which is a three-tier structure. Institutional Biosafety Committee (IBSC), Review Committee for Genetic Modification (RCGM) and the Genetically Engineered Approval Committee (GEAC). For any transgenic product to be cleared, it is mandatory to go through this entire procedure which clears the product only after obtaining exhaustive data collected from multi-locational demonstration sites. Similarly in the area of drug development also, after completing the procedures the necessary clearance is required from the drug controller before the product can be released. As mentioned the regulatory procedure is in place. These guidelines have been very well appreciated by many countries.

Q. The biotechnology entrepreneurs of Indian origin feel that venture funds are not easy to come by. Is this correct? There is also a feeling in the industry that it is easier for foreign companies to come and set up shop here than domestic companies. How will DBT allay such fears of the biotech industry ?

A. The industrialization of biotechnology is strongly promoted and encouraged by the department specially for developing joint R&D programs etc. A special biotechnology venture fund has also being proposed along with certain venture capital companies. This is under consideration.

Q. Is the DBT planning to evolve a national consensus on the introduction of genetically modified organisms and foods in the country ?

A. Yes, the regulatory procedures required for introduction of genetically modified organisms in the country have already been outlined in Point No:9. The department is making a conscious effort to create public awareness and a large number of roving seminars are conducted across the country to promote this and bring before the public the scientific data, proving the benefits of this important technology.
 
Q. How has the Indian participation in the rice genome and human genome project helped the national and international efforts. Is there a plan to participate in the international project to map the Wheat genome and other such important crops?

The participation of India in the rice genome has been widely acclaimed at the global level. The achievements of India in the rice genome programme have been remarkable and the scientists have been able to exceed their targets of sequencing 10 Mb of chromosome level and on date nearly 15.6 Mb of sequence data has been announced. 

Although India did not participate in the human genome sequencing project initially, however, major Indian initiatives were launched since Ninties. India is working on many projects in post genomic activities. Functional genomics, gene identification, isolation and related research, stem cell biology and bioinformatics are supported in a big way.

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