The Department of Biotechnology (DBT), under the Ministry of Science and Technology, is in the process of preparing a vision document for Indian biotech sector. The “Biotech Policy” is to give a road map for this promising sector in the coming years. The DBT is busy holding consultations, interactions with all stakeholders to finalize the priorities that need to be considered for the larger good of the society. The department is also working out a major framework where the private sector can directly partner with the DBT in the latter’s attempt to make biotech drugs both preventive as well as curative available and affordable.

In an exclusive interview, Dr Maharaj Kisan Bhan, secretary, DBT, spoke at length to Joe C Mathew of Pharmabiz.com about the policy that's in the making. Dr Bhan, himself a scientist of international repute is the guiding force behind India's success in rota virus vaccine research. With over 190 international and national research publications to his credit, Dr Bhan has been part of numerous policy-framing committees of the government of India and international agencies in the past. A recipient of the Shanti Swarup Bhatnagar Award, for medical sciences, Dr Bhan has taken charge as DBT secretary with a mission to channelise Indian biotech research sector and put in place appropriate regulatory framework for the industry. Excerpts:

Indian biotech industry has been clamouring for relaxation and streamlining of current regulations and rules for facilitating growth. What changes would you propose in the present regulatory structure to help the growth of biotech industry?

Indian biotech drug industry will have all its problems solved within a couple of months. The expert committee headed by Dr R A Mashelkar that looked into biotech regulatory issues has addressed most of the industry issues with regard to pharma regulation. The report of the committee, which is almost finalized, would be announced soon. Since it is a report prepared by a joint team representing the ministries of Health, Science and Technology and Environment, the conclusions are going to be a consensus document. Due to the same reason, its recommendations will be implemented without delay. Simple procedural changes issued at the department level can solve these problems.

The GEAC will confine its regulatory role in terms of product approvals only if the products are Living Modified Organisms (LMOs). GEAC will be responsible to evaluate the environmental impact caused by handling and use of LMOs, assess environmental risks within certain pre-determined limit and estimate the benefits that are likely to accrue to society. All recombinant products whose end results are proteins will not go to GEAC. DCGI will be the final authority in all these cases. This means that 90% of the pharma cases that are presenting reaching GEAC for clearance today, can be cleared at DCGI level itself.

The recommendations will be implemented within a month of its finalisation as it is not the decision of the Environment Ministry, but a collective decision of all regulatory agencies functioning under various ministries. We should appreciate this cooperation from all the ministries. From my point of view, the issues of the pharmaceutical industry have been taken care of.

The biotech drug industry has been demanding the setting up of an autonomous “Biotech Regulatory Authority” which can take care of the entire regulatory needs of the sector. Is it going to happen?

A single regulatory authority cannot be considered as an immediate solution. It may take several years for this to be a reality. It needs lot of good will from all quarters to make it possible. We need to create sufficient human resources. Officers may have to be shifted from all related departments to the new regulatory body. There is a need for professional officers. We have addressed all these issues in the Mashelkar committee.

It is known that a Biotech Policy is in the making. With the government of India already having an S & T Policy, how different would be this new policy statement?

My idea is to prepare a 10-year vision document for biotech sector through Biotech Policy. We have called for a dozen brainstorming sessions to identify the problems and prospects of each sector that comes under biotech umbrella. Thus, a series of meetings are to be held on sectors like diagnostics, nanotechnology, bioinformatics, environment, plant-based medicines etc. Experts from industry, academia and government will be invited to express their views in these meetings. We expect to complete the first round of meetings by December 2004. The sector-wise meetings will give an idea about what the government has to do the next 10 years. The policy will clearly talk about the government’s priorities and how it plans to invest its energies and resources in the next decade for the benefit of the industry. We need to make full use of the resources we have. The policy will be ready in six months from now.

What are the fiscal incentives, infrastructure facilities you would recommend for biotech sector?

We are working on several incentives for the industry. The finance minister has been briefed of the needs of the industry. All biotech parks in the country have been cleared from duties in the recent Foreign Trade Policy. They are now to enjoy all the facilities that are offered to EOUs. This itself is a major success. We had asked for other concessions as well. Given the short period within which the entire budgetary exercise was done it was difficult to package everything. We expect more in the next budget. Setting up Biotech development Fund is one of the major demands of the industry. We are working on that. We would like to see public-private involvement in the creation of such a fund. We will be seeking necessary approvals soon.

We have decided to support biotech parks in the country. Our responsibility would be to see that the kind of biotech parks that come up in different parts of the country are not mere duplication of efforts. With an idea to optimize our results, we will provide necessary guidance to see that every biotech park has an identity of its own. The policy will lay down clear-cut directives in this regard.

DBT should move aggressively towards building up private-public partnerships for raising sufficient funds for biotech R & D. It should be able to attract people with original ideas and develop these new ideas into valid research programmes. Setting up adequate infrastructure for carrying out the research would be the next step.

We have already discussed number of projects with the industry. For example, our discussions with Serum Institute of India for developing pneumococci vaccine are in an advanced stage. We have already identified areas. The bigger responsibility is to see how we can intensity the development of products at a faster pace than we do. You need to choose appropriate technologies with a very sense of market potential. Post 2005 you will have to sweat out to create new products if you want to be in the race. Next year our budgetary allocation will certainly be more. But we will intensity our focus on joint ventures. DBT has overcome all its teething troubles. Now it needs to position itself in such a way that it helps researchers and the industry to develop leads that can be translated into commercially viable new products.

What are the areas in biotechnology research that needs urgent attention?

Strengthening of our clinical trial capabilities is one important area where we should focus on. For this to happen, the DBT and ICMR should be looked at as sister organizations. Fortunately, a firm partnership is in the offing where both the organizations are working together towards fulfilling national interest. Representatives from both ICMR and DBT are part of every major committee set up by these institutions. This has led to a situation where the decisions and recommendations made are not of one particular agency, but a combined decision.

The key is partnership and there are several areas including AIDS / HIV where such partnerships are already in place. Leveraging on the strong consensus built in between ICMR and DBT we hope to bring in much improvement in the clinical research area. Model clinical trial centers should be set up for the benefit of the private sector. Such centers should be linked to actual work and core support should be given from all sides. We need to have constant and repeated interactions with small focused group of industries to identify our priorities.

Diagnostics is an area where DBT needs to concentrate. We need to develop indigenous diagnostic tools that are reliable, simple and affordable. Development of vaccines for diseases affecting developing world is another challenge.