Discussion on the motion for consideration of the Regional Centre for Biotechnology Bill, 2016
25/April/2016

I rise to speak in support- but in conditional support-of the Bill that Dr. Harsh Vardhan ji has just introduced before us.

          We all know, as he pointed out, that the growth of technology is revolutionizing the way we all lead our lives. Frankly we are struggling in many ways to adapt to its demands.  So, the Bill  is important.  I was listening attentively to his introduction.  Biotechnology, of course, is not really a new Science, in the sense that in earlier forms it has existed perhaps for centuries.  But, as he rightly said, in its modern manifestation, Biotechnology involves the manipulation of the genetic structure of organisms and introduction of characteristics that can actually bring in specific traits that are helpful to human beings.  This is relatively a new Science and I am very pleased that India is very much in the forefront in Biotechnology. 

          One could argue that the development of the field through, for example, the advent of genetics, has opened really exciting opportunities in this sector.  There are many applications-and he has given some examples, which I would not repeat- but overall they promote the improvement of human health, food production, reduction of environmental or damage.  Insulin and Hepatitis vaccine have already been mentioned.  BT cotton has been a big success story.  We used to be  short of cotton, now we are exporting cotton.  It is one of the great satisfactions of the UPA Government that we did the work on BT cotton. 

          I do want to stress, hon. Chairperson, that in this new era in the history of mankind that we are talking about, biotechnology is going to increase rapidly in India.  There is no question about it.  The applications of modern biotechnology have a great future here, the same for around the world.  It holds great potential to give us new solutions, solutions we cannot perhaps even imagine today, for the health and quality of life of our Indian citizens, plus, of course, the significant improvements in agricultural productivity that he mentioned, more nutritious food as well as sustainable development.  Sustainable development means development where we pay regard to the environment, and that may be easier to do with biotechnology.

          I am increasingly convinced that biotechnology has the potential, Mr. Chairman, to replace information technology as the  main engine  for development of India and, indeed, of the world.  This is why I am quite pleased to welcome the points made here by Dr. Harsh Vardhan. I would add to those, gene therapy, another tool that holds  great potential for hope. Even though we do not know enough about it yet but the prospects are there. Xeno transplantation, which involves transplanting body parts from animals into human beings, is being talked about.  We are not yet there in that area. The Chinese are ahead of us. Nano technology is in a process of transition here. Then, of course,  from a security point of view, the risk of bio-terrorism cannot be  underestimated.  We are facing such serious terrorism threats in our country, and the fact is that there are serious implications if biological agents can be used to harm our people.

          I agree with the hon. Minister that India is poised to emerge as a force, a real force to reckon with, in the biotechnology sector.  We are well on the way to being a  10-billion dollar industry already. That is why the industrial applications are important.  It is a great opportunity for companies in the private sector as well, and they need to work with academic institutions to network and develop ties between universities and industry so that our growth of biotechnology can proceed in both areas. 

This is why, Mr. Chairman, I am so pleased to   welcome the Bill as it has been put forward to us here by the hon. Minister. Nonetheless, there are a few things that I want to bring to his attention as he moves forward with this Bill. That is why I spoke of conditional support.

Firstly, we still need to do a great deal more, Mr. Minister, in improving the quality and quantity of our biotechnology graduates to meet the demands of the biotech industry.   There is an independent report by Ernst & Young, which is actually quite critical both of the   number of biotech graduates that we have -- perhaps because of the paucity of institutions  -- and also of the  quality of many of these graduates. I think, we need to address that.

          Secondly, the Government itself is lagging behind. Dr. Harsh Vardhan said that this has taken a long time. There are other things that have taken a long time. I think that the Indian Government quickly needs to enact regulatory reforms and do much more on the infrastructure front as well, as well as providing more incentives to biotechnology.

          I will   come back to regulation in a minute. But inadequate infrastructure is pointed to by everybody. Even the existing leaders of the biotechnology industry such as the founder chairman of  Biocon, Kiran Mazumdar-Shaw, said in an interview that ‘it is really a crying shame’ what our infrastructure is. And, I am sure that Dr. Harsh Vardhan will want to talk to his colleague, the Finance Minister, about providing some financial incentives to the biotech industry, which  frankly, are simply not present, right now.

          The hon. Minister mentioned that   this Bill will grant the new institution in Faridabad set up in 2009,  the status of an Institution of National Importance. That is very important. I welcome that.  But I do want to point out that in my Constituency, Thiruvananthapuram, the Rajiv Gandhi Centre for Biotechnology, which Dr. Harsh Vardhanji had visited with me a few months ago, was established seven years before the institution in Faridabad, in 2002. I have also been requesting its upgradation to the status of an Institution of National Importance. We know the case for the Faridabad centre is that it would provide them with facilities such as ease of   technology transfer, recognition as a global platform, the right to give degrees, resources for conducting quality research. But in their welcome focus on this new institution, they should not forget the earlier ones, and I am sure that Dr. Harsh Vardhan, who had a very positive visit to the Rajiv Gandhi Institute in Thiruvananthapuram, will agree with me that we do not want to leave a pioneer in this area by the wayside. I really feel that we need to offer this kind of support.

          I want to point if I may, to Wikipedia, which has a ranking of the top 10 schools/universities offering courses in biotechnology in India. Number one is the Institute of Chemical Technology in Mumbai and number two is the Rajiv Gandhi Centre for Biotechnology in Thiruvananthapuram. I am afraid the Faridabad Centre does not get featured in the top 10. So, we have a long way to go. I am not in any way speaking against an institution. I want more institutions in our country and I want them all to be good. But please honour the ones that are doing well; that are working well; and that require support.

I also want to point to one particular point in the Bill that Dr. Harsh Vardhan did not mention in his remarks. He mentioned the various objectives in the Bill and I do not think we have any fundamental problem with them. But one of the functions spelt out in Section 9 is, “to develop and implement a policy for Intellectual Property Rights (IPR) with equitable and just provisions for all stakeholders”. Now, this is a priority function, as you know, Mr. Chairman. The preservation of intellectual property is a broad principle that India is committed to but the Intellectual Property Rights of biotechnology research has been a major concern, partly because of the complexity of provisions in IPR laws around the world, and certainly our own IPR laws have left something to be desired.

 Now, in this context I do want to mention that there are a whole number of issues with regard to TRIPS. Our patent laws do not match the trade related intellectual property laws that we have signed up to as a Government and I would urge the Minister to pay some serious attention to this question of reconciling trade related intellectual property rights to our Indian patent laws, and if necessary, moving to amend our laws as appropriate or  if not, at least then to put conditions on our accession to the TRIPS because this again becomes a significant factor in the growth of the biotechnology industry.

          Mr. Chairman, then, I want to express some concerns. Many of us have some disappointment that this House has not enacted a Bill from the UPA era, the Biotechnology Regulatory Authority of India Bill, 2013. We introduced it in the Lok Sabha in April of 2013. It was referred to a Committee. It never came back to the floor with all the various disruptions of the House and in the end it was not adopted. Of course, the Bill that was introduced in the Lok Sabha lapsed when the previous Lok Sabha got dissolved. I would like to urge my good friend, the hon. Minister to take up this issue.

          The question of regulating biotechnology has to move side by side with all the enthusiasm that he has rightly shown for this creation of the institute in Faridabad. And, in regard to the new Bill, I am all in favour of us cooperating with UNESCO. I have welcomed the fact that we want to be a hub for the other countries of South Asia and South East Asia. All that is fine. But what is the regulatory framework under which our biotechnology work is going? This institute has not been planted out of nowhere. There is a context. The context lies in the laws, rules and regulations of India, which, very frankly in our own estimation as a Government, when we were in Government we felt, were inadequate for the challenges that the country faces, and, we, therefore, produced a draft Bill for regulation.

Now, we are not wedded to one particular Bill or former Bill. But we would urge the Minister to go back to that Bill, resurrect it, taking into account the findings of the Committee that looked into the Bill in 2013, which I believe, has submitted its report and then to see whether we cannot move both side by side. Yes, we can go ahead and adopt this Bill today. But as part of the process, you are creating institutions. You are saying they are of national importance. Let us also, as part of that process, have an adequate regulatory framework. That is also of national importance. This is required by the Convention on Biological Diversity which we are a signatory of. It is also a part of the Cartagena Protocol on Biosafety because after all, regulation is not only about control or command and control. It is about safety as well. I myself am not a great fan of command and control systems. What we are worried about is, under what framework will these institutions grow and how can we ensure that we are also kept safe in the process?

          The purpose of regulation must be the protection of the Indian people just as the purpose of the growth of biotechnology must be the prosperity, the health and the wellbeing of the Indian people. So, I think we cannot disagree with the objectives. We are all of the same view. We do know that some of our friends in the environmental NGOs have a slightly more challenging notion of some of these issues when it comes to us and when it comes to issues of biotechnology.

          I do not want to enter into all those debates here because we will needlessly take up the time of this House. It is certainly worth returning to this debate on a later date because very recently, one of our major media outlets had an interesting column attacking the political establishment for having been so backward in its attitude towards biotechnology in relation to agriculture. I am sure that many would agree that we can be more imaginative in extending the benefits of biotechnology.

          Having said all this, let me once again welcome this Bill and request the hon. Minister to, along with it, look at the Regulatory Authority Bill, to look at the patent structures in the country, to look further at the inadequate infrastructure that is hobbling our biotechnology companies and, finally, to encourage our biotechnology companies and academic institutions to work together. When you have an institution like this one in Faridabad, it would be very helpful if they were encouraged – indeed permitted in the first place – to have a relationship with private sector companies so that they can do collaborative research with industrial applications and marketing potential. Can you imagine a situation where a company goes to this institute and says that ‘we have here ‘X’ number of rupees to offer. If you have the right kind of Ph.D. students, we want you to research this and we will help you. Then, if you actually find a solution, we can patent it together or you can patent it and we can produce it and we can share the profits.’? This kind of thing happens routinely in the Western world. It does not happen enough, if at all, in our country. I urge the hon. Minister, in administering this institution, to ensure that all these possibilities are also included.

          With these words, Mr. Chairman, I would like to express our support for the passage of this Bill and hope that these other ideas will be taken forward in its implementation in the years to come.

          Thank you.



Source: http://164.100.47.194/Loksabha/Members/DebateResults16.aspx?mpno=7048
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