Cross Talk

Kapil Sibal readily agreed to an interactive session, Cross Talk, to field questions from a group of CEOs. The Talk, which lasted for about 30 minutes, saw a host of questions about the industry being answered deftly and crisply by the erudite minister. It was anchored by BioSpectrum publisher, Pradeep Gupta. Excerpts from the Cross Talk.

Pradeep Gupta, managing director, CyberMedia (India) Ltd

You have said in your interview with BioSpectrum that 'Biotech is the best batsman in your S&T team'. How do we make the best batsman into a master blaster? Also, as every team has a best batsman, how do we make it the best team in the world?

When I said biotech is the best batsman in my team, I assume biotech as just one entity. There are 10 others players who will also have to make biotech work. For the team to succeed and the best batsman to be a master blaster, we need all those 10 players to contribute. Those 10 players include the government's tax policies, the procedural things that need to be put in place, GEAC, etc. Unless all that happens, the master blaster will get a tendon injury. What we need is people working together. And that is why I have spelled out the road map that is needed to make the Indian biotech successful. We need the environment, the funding, a Bayh-Dole kind of legislation, tax concessions, biotech parks, access to cell lines and biological material. Besides we need start-up companies to invest more in R&D. If all that works, biotech will be the best batsman in my team.

Varaprasad Reddy, managing director, Shantha Biotechnics

You clarified that the streamlined regulatory system will be in place by November. But like the entrepreneurs who are accountable to the financial institutions and stakeholders on timelines, will the regulatory institutions also be made accountable?

There are four kinds of biological material-no risk, low risk, medium risk, and high risk-handled by the industry. As far as the "no risk" to "medium risk" categories are concerned, there will be no problem after the recommendations of the Mashelkar Committee come into place. And the Department of Biotechnology (DBT) is going to handle it. So as and when the request is received, clearance is given. 'If the request is today, it should have been cleared yesterday.' That is the way in which we have to function, if we as a nation have to move forward. We (the government) must function more like the corporate sector and you (industry) must have the concerns of the public in mind just as we do. Unless that marriage takes place, nothing is going to move forward. So if your request comes, we need to move forward and once you have the material, you must use that ethically in the public interest and do all the things that are right in order to contribute to the well being of the nation. I can promise you that from my department. I cannot talk about anybody else. There is no question of timelines. It will happen immediately.

As far as the "high risk" stuff is concerned, we have to go through certain approvals and that has to be done. Agreed timelines will be followed.

Will your ministry take steps to get various biotech drugs and vaccines included in the universal immunization program?

The universal immunization program in the country is being conducted for vaccine preventable diseases. Drugs are not included in this program. The Ministry of Health and Family Welfare considers inclusion or exclusion of different vaccines through a special mechanism of consultations with various stakeholders. I am willing to help you in the process by requesting the health minister to consider your demand. But from my side I am willing to help you in every way.

KO Isaac, CMD, ABL Biotechnologies, Chennai

You have answered several questions related to the diagnostics sector. Cost is something that we are concerned with. Can something be worked out to manufacture diagnostic kits within the country in an affordable way?

I support you in that effort. I want to help you. The issue of making duty free import of reagents and components in preparation of various diagnostic kits within the country has been debated in various forums. The Ministry of Science and Technology, in general, and the Department of Biotechnology, in particular, have been recommending duty free import of diagnostic reagents to the Department of Revenue from time to time. However, any structural changes in duty rates for specific commodities require all the relevant information from the industry. You have to come and give me specifics. 'The industry also needs to be a little more proactive, every time you expect the government to be proactive.'

Subash Lingareddy, president, Ocimum Biosolutions, Hyderabad

Is there any plan to develop specific capability clusters in India? For example Bangalore could be the 'Proteomics cluster' and Hyderabad could be the 'Genomics cluster'.

The secretary of DBT has talked to me about this and he wants to emphasize on proteomics and that discussion can be carried forward. It is a welcome step.

Paresh Verma, director, research, BioSeed Research India, Hyderabad

What are the steps being taken by the government to accelerate the availability of approved technology in new generic background? I am talking about the technology that has already been assessed for biosafety risk and approved as safe.

With the new procedures that are going to be put in place, all that is going to be streamlined. You should not have a problem on that. The government has approved 20 Bt cotton hybrids for north, central and south zones of the country, with diverse genetic backgrounds. This approved technology is being sub licensed to more than 20 seed companies and all of them are in the process of evaluating their best Bt cotton hybrids suitable for different agro-climatic zones. Further several hybrids with two new Bt cotton technologies are also under large-scale evaluation. In coming years, more and more Bt cotton hybrids with diverse genetic backgrounds would be available to farmers. It must be remembered that this is nascent industry and in couple of years, things will be further streamlined.

The concern of the industry in general is that we are looking at a particular variety or hybrid as a biotech product, rather than biotech trait as a biotech product. Can we do something?

I cannot answer that because it has biosafety implications and I am not qualified to answer that as I do not know if the trait by itself is enough to take care of the biosafety considerations or not. I will go by the experts' opinion.

Do we have the necessary framework to handle the GM food crop production in downstream applications?

As on date, no GM food or GM food crop has been approved for commercial purpose by the government. No GM food has been permitted for marketing also in this country. However, Bt brinjal is undergoing food, feed and environmental biosafety evaluation. Apart from brinjal, cereals and other food crops like rice, pigeon pea, tomato, brassica, cauliflower, cabbage and okra are in various stages of biosafety evaluation. The major issues involved with the GM crops are to address human and animal health safety apart from environmental safety.

As regards to the regulatory process for downstream food crops, meet me and suggest what should be put in place. We will do the necessary spadework within the government to ensure that that is done.