Comments on DBT's Biotech Policy:
Dr. M K Bhan,
The Secretary,
Department of Biotechnology,
Ministry of Science and Technology,
Government of India,
Block-2, CGO Complex, Lodhi Road,
New Delhi 110 003,
India
Dear Dr Bhan:
The Foundation for Biotechnology Awareness and Education (www.fbae.org), Bangalore, deeply appreciates the release of the Draft of the National Biotechnology Development Strategy (NBDS), and more so for inviting in puts from the public. Such a policy document is long overdue and hopefully this would become the Government’s biotechnology policy for the ensuing decade.
The FBAE submits the following inputs for your consideration while finalizing the NBDS:
1. We understand that the Task Force (TF) constituted to draft the policy met just twice and that too not in full complement. More meetings would have provided an opportunity for a detailed discussion of the Draft and a consensus. The public criticism of the Draft by Dr Suman Sahai, Gene Campaign, a
member of the Task Force, sends wrong signals on the issue of consensus, as already brought to your notice by FBAE, by an e-mail, on May 10, 2005.
2. There is considerable dissatisfaction that the TF did not have adequate representation of all the stakeholders. There was only one NGO, the Gene Campaign, though some other NGOs (including the FBAE) participated in the meeting of the Subcommittee on Public Trust Chaired by Dr M S Swaminathan.
3. Adequate time should be now taken to seriously consider this Draft, along with the inputs received by the DBT. The release of the NBDS should not be hurried to meet with an arbitrary deadline or as political expediency.
4. The DBT must adopt a policy of transparency and post all inputs on its website. Our experience with the Government departments both at the Centre and the States is a little demeaning. We send lot of material and write letters, which are not even acknowledged. We understand the amount of work involved in responding to all the letter and material the departments receive, but we are only trying to help the Government. For example, the promised minutes of the meeting of the Subcommittee on Public Trust were not received by the participants.
5. ‘Vision’ and ‘Mission’ should not be clubbed together as they are two different perspectives.
6. Any policy needs clearly stated strategy of phases and a time frame of implementation of the phases. This is largely unclear in the Draft. Without a committed time frame for the deliverables, next ten years will come and go in a wink and there will be nothing to show for all the effort. Unless responsibilities are fixed and DBT personnel are made accountable for action and lapses, nothing beneficial would come out of the policy.
7. It is as important as the Policy, to identify and allocate adequate financial resources to implement the policy. This aspect was not seriously considered in the Draft.
8. The confidence to create one million jobs by 2010 is an unrealistic projection. It is this kind of hype that has thrown biotechnology into disrepute. What category of jobs are they and can we train so many people to handle the responsibilities in the coming five years?
9. Creating biotech leadership is different from creating a large work force. Offering a meager 200 Ph.D., fellowships, for a populous country like India, is like a drop in the ocean. At the bare minimum, it should start with 500 fellowships that can be increased to about 5000 in the next 10 years depending upon the track record.
10. What is the point in instituting fellowships at the Ph.D., level without creating facilities for the proper utilization of these fellowships? For this you should ensure that adequate and appropriate facilities for graduate and postgraduate education and training are in place, which would demand heavy financial inputs.
11. Biotechnology is not a single subject; it is a conglomerate of several areas of biology, chemistry, physics, mathematics and information science. The DBT, in association with bodies like the UGC and CSIR, should first institute 1000 All-India Postgraduate Merit Scholarships in all relevant subject areas and not just biotechnology courses, so that adequately qualified people would be available to compete for the Ph.D., fellowships. Candidates for both the PG and Ph.D., fellowships should be selected in open competition, exclusively based on merit, subject only to the national statutory reservations.
12. In India, the current state of biotechnology education is pathetic. There are thousands of institutions pretending to be serving the cause of biotechnology handing out only hype. There is no competent and appropriately qualified staff in adequate numbers, and no infrastructure but the costs of this ridiculous sham are enormous, cheating the parents and shattering the hopes of the young aspirants. There are no facilities to impart hands on training in the degree and PG courses in biotechnology. People who have been in conventional subjects overnight have become biotechnologists. There must be a policy guidance to streamline biotechnology education in the country.
13. Teacher training programs are essential and should cover all relevant areas of biology and chemistry. But imparting teacher training at regional teacher training centers is coming back like a bad penny. Even the refresher courses have not been very effective, as teachers attend these programmes for the sake of certificates. This kind of outdated approach is wasteful. Biotechnology and the relevant areas are dynamic, whose teaching needs cannot be according to a fixed formula, that has been the main failing of all Indian educational establishments. Biotechnology must be taught and learnt at Biotech Training Centers and not at teaching centers managed by those who have never done biotechnology. The DBT should establish at least one such center in each State.
14. Currently there are several different streams of biotechnology education: a) DBT sponsored courses, b) UGC sponsored courses, c) AITCE sponsored courses in engineering colleges, d) courses run by the Universities and in colleges affiliated to them and e) private operators mostly in bioinformatics. There are also institutions that promise hands on training in various aspects of biotechnology. Many of the private operators confer Diplomas and not certificates. We believe that while any institution may give a certificate, only statutory institutions should offer a Diploma, an equivalent to a degree. What is urgently needed is an autonomous body that will provide guidelines, basic curricula, rules and regulations on minimum infra-structural and faculty requirements, for various aspects of education and training and to recognize institutions with adequate facilities. More importantly, this body should have the teeth to discipline and to de- recognize institutions, if necessary. This body may be called the Biotechnology Council of India on lines similar to the Medical Council of India, Pharmacy Council of India, Bar Council of India and such other autonomous statutory institutions.
15. Barring the functions of the Biotechnology Council of India, biotechnology education, training and research should be under the control of the DBT. Now almost every funding agency claims a piece of the cake.
16. As it would take time for the Biotechnology Council of India to be in place, the DBT in the meanwhile should generate a document-stipulating minimum infrastructural and faculty requirements for degree and PG courses, for a specified intake. The provisions of this document must be fulfilled before an institution gets provisional recognition to run courses in biotechnology.
17. There are no appropriate and adequate laboratory facilities for training and conducting research in the country. It is both unnecessary and wasteful to create instrumentation and other facilities in every one of the several thousand institutions. The DBT should consider establishing Biotechnology Service Laboratories in different states and in important locations in districts, where students can do some project work and researchers can use a facility like PCR or HPLC or NMR, on payment of reasonable costs. Such laboratories can be associated with Biotechnology Training Centers.
18. The Draft rightfully recognizes India’s need for an army of highly competent microbiologists. The policy should make provision to support education, training and research in microbiology in all its ramifications.
19. Biosafety and Environmental safety are distinct from each other and so are risk assessment, mitigation and management. It should be emphasized that all these are matters of science to be entrusted to adequately and appropriately qualified scientific bodies. Regulation of biotechnology products is an administrative issue. There is no room for appeasement of pressure groups in any of these.
20. The proposal to institute a DBT sponsored biotechnology management course to include regulatory affairs, IPR and bio-enterprise management is a laudable idea that requires financial provisions made in the policy. A separate Task Force needs to be established to develop an action plant for implementing this idea.
21. The Draft mentions that of the five billion dollar global market opportunity, five million dollars would be the share of the agricultural biotechnology sector for India. Considering that current world market of agbiotech products is no more than 400 million dollars, it is hard to imagine that India’s share alone will be 500 million dollars within the next decade. India’s agricultural biotechnology has just taken a baby step and has a long way to go before it can become a mature industry. We have faltered so much in handling just one worm and one plant. You should make realistic projections devoid of hype.
22. There must be a single common basic national biotechnology policy managed by the DBT. The ICMR and ICAR can have their own policy addressing the areas relevant to each, but within the framework of the national policy. Presently the ICMR and the ICAR sing different tunes.
23. It should not be made mandatory for small entrepreneurs to partner with a public institution for obtaining soft loans. The public institutions will largely exploit them, unless sufficient safeguards are included. The only criterion should be that the entrepreneur has a real good idea with a potential to succeed.
24. Biotechnology parks can thrive only when they are closely associated with first class academic and research institutions, both in the private and the public sectors. Now political correctness and expediency dictate the announcement, and not necessarily establishment, of Biotech Parks in all sorts of places and contexts.
25. Regarding strategic actions governing regulatory oversight mechanisms, you seem to excessively depend on Dr. MS Swaminathan Task Force report on agricultural biotechnology, which may not be a good idea in all respects.
26. The idea of placing an independent or autonomous regulatory authority in the Ministry of Agriculture is not a sound idea, as that would compromise the independence of the body. It should be a stand-alone regulatory authority with its own scientific staff, housed on its own premises.
27. The proposals of ICMR, ICAR and the current draft regarding an apex regulatory body, in place of the current GEAC, either overlap or are in conflict. There must be only one regulatory authority, whatever nomenclature is applied to it. Such a body (the new GEAC?) should be entrusted with regulating all categories of biotech products, whether agricultural, industrial or medical, basing on inputs and recommendations from the concerned evaluating body, such as the RCGM. The apex body should be autonomous and not under the control of any Ministry. When one compares Mashelkar’s and Swaminathan’s reports and the present proposals of the DBT, it seems necessary that the question of the regulatory body is separately discussed in depth and a consensus is reached before the new apex regulatory body is statutorily constituted. Dispute resolution should be an important function of the apex body itself. There is no need for or point in having someone else to hear disputes and rule on the decisions of the apex body.
28. There seems to be a misunderstanding, of the term ‘transgenic event’ (page 18, under Strategic Actions, item ii). The ‘transgene’ in question, such as Bt-Cry 1Ac may be clear, but a transgenic event is that transgenic line of a transformed tissue that was developed into the transgenic variety. For example, it should be adequate if a Bt-Cry 1Ac gene that has already been evaluated in one variety of cotton to be deployed into another variety of cotton without too elaborate testing, but it is not acceptable to approve the same evaluated Bt Cry 1Ac gene deployed in corn or soybean or rice, etc., without full scale regulatory review and testing. Otherwise, this would violate the basic principle of risk assessment that calls for evaluating the interactions of each transgenic organism with the environment into which it is being introduced.
29. The proposals for public awareness and communication are sound. You would need a national level body to develop and implement an active program, which again requires huge financial resources. The industry should actually contribute to this effort and actively take part in the programmes.
30. Bioresources program should be taken care of by the newly proposed National Science Foundation and DBT must stay out of it.
31. Animal and plant resources must be the purview of the Zoological Survey of India and the Botanical Survey of India, respectively. DBT would do well to stay out of it, as it has no expertise or knowledge of these two resources.
32. No thought seems to have been given to the issue of bioethics, which should be an item of top priority for the DBT, ICMR and ICAR. Also consider the fate of the existing National Bioethics Commission, if DBT becomes the chief operator, under the new policy.
33. Industrial biotechnology is no longer a new wave. DBT’s role in the development of industrial biotechnology should only be in formulating a robust policy for corporate social responsibility, in addition to providing guidelines on what types of technology should be addressed by the industry and its regulation in terms of biosecurity. You have rightly recognized the need for capital investment so that private entrepreneurs will take the lead. Government agencies are especially bad in dealing with industrial growth. Policy and resources for venture capitals is all that you need to take care of and the rest will follow.
34. The proposal to ban development of transgenic crops and commodities where international trade may be affected is disturbing. This idea was apparently borrowed from Swaminathan Committee’s report, where the proposal found place more on account pressure from the anti-GM lobby, rather than sound science. The question should be whether a particular crop requires to be improved and for what traits. The second question should be if that improvement is possible by conventional means. Most conventional crop plant improvement programmes have virtually failed, leaving the only option of genetic engineering. The key factor in adopting or not adopting genetic engineering should be based on crop reproductive biology and the distribution of wild relatives, which vary from crop to crop. The issues should be decided basing on also the genetic trait to be deployed and the crop in question, with adequate concern for biosecurity and trade issues. While questions of Centers of Origin and Diversity are important, they cannot be the sole deciding factor, as emotion and not sound reason, is the driving force behind these issues. One should keep in mind the progress China has made in genetically engineered rice and that Pakistan has been producing genetically engineered Basmati. There may be a NGO flutter but that did not affect the market potential. The market would favour a quality product and not an emotional tag. The policy document should leave this issue to be resolved, considering crop-by-crop and trait-by-trait, when a situation arises. For example for rice, we need varieties resistant to diseases, pests and abiotic stress. If a ban is envisaged in the policy document itself, it would be used to block all biotechnological improvement of crops in India. Hence, a blanket policy ban, as vociferously advocated by one member of the Task Force, is ill advised. This is an area where appeasement should not be even the last criterion. India is actually in a position to lead the rest of Asia in genetically engineered crops but would soon loose the advantage to other Asian countries, if not vigilant.
35. The DBT must not be tempted to start new institutions unless absolutely needed. Existing relevant institutions should be suitably mandated and upgraded in terms of finances and manpower to take up new responsibilities. Mandate transgressions should be controlled. Instead of new autonomous institutes for marine biotechnology and herbal medicine, the responsibilities should be given to NIO and the CIMAP, respectively. Similarly, there is no need for another autonomous institute for national biotechnology and/or food biotechnology. We already have two reputed institutions, the NIN and the CFTRI, which can handle the relevant issues. A national center for food safety should be housed in CFTRI, an organization with international reputation, instead of creating new infrastructure. It is not necessary to have a new gene bank to store all genes, which will remain an empty bank, as no private institution would deposit the genes it has developed, more particularly because of IPR. The NBPGR is competent enough to store publicly accessible genes. A Centre for Translational Research is unnecessary as there are several institutions that can take up this work.
36. A lot of money and time have been spent on biofertilizers and biopesticides in the past three decades or so, with very little to show for it. Funding these projects any more than has already been done is ill advised. These technologies have reached a point beyond which they are incapable of growing. No industry based on these two technologies has ever really taken off or remained afloat, even if it did. These
areas need not be abandoned but should not be prioritized either, without a change of direction. A more recent and promising area is development of transgenic crops with genes mostly from legumes, for insecticidal lectins, inhibitors of polygalacturonases and inhibitors of proteases. Some work is going on in India too and such efforts to develop more efficient biopesticides should be encouraged.
37. Biofuels should actually be the concern of the Ministry of non-conventional sources of energy and DBT would do well to stay out of it. Expecting biofuels to fulfill the oil energy demand in the country is a pipe dream.
38. Environmental biotechnology is on the weakest footing in the Draft. It is necessary to constitute an Environmental Biotechnology Task Force, as was done for agriculture and medicine, to examine all relevant issues and concerns and chalk out a quality program for implementation.
39. Biotech policy should make a provision to conduct public hearings, inviting different stakeholders, before taking decisions on basic and important issues. Stakeholders located in Delhi enjoy an advantage over others who are outside Delhi and who cannot finance the visits to the national capital. It would be better if public hearings and meetings were held in the State capitals too. Financial provision should be made to support participation of all relevant stakeholders and organizations in public hearings or meetings at Delhi or in State capitals.
40. The DBT must improve on its communication front. Currently, even minimum courtesies are not shown to people who are trying to help the Government.
Thanking you,
Yours faithfully
C Kameswara Rao
Executive Secretary, FBAE
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