Nanotechnology Regulation in India: Framework for Exploring Risks and Opportunities

1. Nanotechnology Regulation in India: Framework for Exploring Risks and Opportunities Nupur Chowdhury Regulating Nanotechnology ISA Convention March 2006

2. Format of Presentation • Indian State: Regulatory Impetus for new emerging technologies • Drivers of Research Investment in Nanotechnology: Current Developments • Review of existing legislation and judicial prescriptions: implications for Nanotech Regulation • Some broad conclusions

3. Indian state and emerging technologies • Role of the state has been largely ambivalent - adoption of technological revolutions • Post independence – Cold War geopolitics – transfer of technology – energies focused on indigenisation of technologies acquired • Post Seventies – large scale public investment in capacity building – setting up of premier scientific educational establishments – failure to capitalize – investment unrelated to strategic research for commercialization

4. Regulating ICTs and Biotechnology • Nineties witnessed massive success of the telecom and then information technology – government major player – used entrepreneurial experience – to regulate • Strong regulatory posture missing in other areas – viz. biotechnology – despite govt. notification in 1989 – no practical implementation – unwilling regulator • State – caught between need to regulate investment & ensure public good – and pursuing rapid economic growth through private sector investment

5. Regulating ICTs and Biotechnology • Biotechnology – deliberate go slow – wrong signals to wary investors • Risk discourse within government regulation of emerging technologies – defensive reaction – widespread criticism • Confrontational posturing – zero sum game – government needs to engage with the public – transparency – right to information

6. Regulating nanotechnology • Government several steps to facilitate public sector investment – postponed regulatory initiatives – argument – nanotechnology is still at a nascent stage – stand dissimilar to that vis-à-vis gene technology • Nano science and and Technology Initiative – fundamental research program – focussing primarily on equipments research

7. Research Investment in nano technology • Nano Science and Technology Initiative (NSTI) – launched in Oct’ 2001 national program of Department of Science and Technology – Centers of Excellence • Nano Research – within government – DST, DRDO and the DBT – DST overall responsibility- unclear the reviewing authority of DST.

8. Research Investment in nano technology II • NSTI – four specific areas of research – distinct plan on the part of the government – focus research – areas of significant commercial results – identified areas – nano drug delivery systems – leverage India’s present leadership in drug manufacturing • Overt focus on commercialization – lead to neglect of research on environmental and safety aspects of nanotechnology

9. Research Investment in nano technology III • NSTI – four specific areas of research – distinct plan on the part of the government – focus research – areas of significant commercial results – identified areas – nano drug delivery systems – leverage India’s present leadership in drug manufacturing • Overt focus on commercialization – lead to neglect of research on environmental and safety aspects of nanotechnology

10. Government Initiatives • Currently research funded amounts to US $ 5 million – public – private partnership – few leads – Dr. Reddy’s • Soft loans – TIFAC and Technology board • International Collaborations – ARCI • Indo-US Science and Technology Forum

11. Regulatory Imperatives • Government’s position – guided by developmental impacts of nanotech research • Regulation – potentially problematic – disincentive private sector investment • Govt. – not unaware of moral, ethical and other issues – plan to sets up an expert body to deliberate on such issues • History of state policy committees – bureaucratic – little public participation

12. Regulatory Concerns • Unknown environmental & health impacts – adequate structures of risk assessment • Ensure investments – adequately focused on developing usages that would generate public goods like – clean environment • IPR – another area of regulatory oversight – market for adequately protected from monopolistic impulses

13. Existing Legislations and judicial prescriptions • Three essential touchstones – regulatory framework on nanotechnology: • Information requirements • Liability for environmental hazards – private investment in commercialization – matched by public investment ins studying enviro-health impacts • Transparency and public involvement – right to information – legal obligation

14. Legislative framework • Environment Protection Act 1986 • Hazardous Waste (Management and Handling) Rules 1989 • Manufacture, storage and import of hazardous chemical Rules 1989 • Bio-medical Waste Rules 1998 • Chemical Accidents Rules 1996 • Rules for manufacture, use, export, import, storage of microorganisms and GM organisms 1989

15. Legislative framework II • Water (Prevention and Control of Pollution) Act • Air (Prevention and Control of Pollution) Act • Public Liability Insurance Act 1991 • Food Safety and Standards Bill 2005

16. Judicial Prescriptions • Hazardous Substances: Court has evolved a rule of absolute liability • Precautionary Principle: • Reversal of burden of proof • Technical capacity of appellate tribunals • Appellate body not restricted by Wednesbury limitations – strong presumption administrative decisions challenged on lower standard of unreasonableness – non-application of precautionary principle

17. Few Broad Conclusions • Several developments – NSTI – government spearheading – opportunity to attract investment • Rapid developments within nanotechnology – high chance of filtration – government oversight required - potentially hazardous • Applications of nanotechnology – growing at a phenomenal space – difficult for regulators to keep pace unless work in tandem • Regulatory oversight – necessary – give direction to research efforts

18. Conclusions II • Role of the government as regulator – government needs to play a more proactive role- public research investments in studying effects of nano materials – health and environment • Rationalization of current legislative structure – if we want to make it applicable to nanotechnology • Contribution of present legislation – huge reservoir of regulatory experience • Reiterate transparency and public involvement

19. Possible research areas • Existing regulatory policy as a possible framework for nanotech regulation: • REACH, SPS, TRIPS, ISO, ICC • National legislative framework and potential for developing nano governance structures (comparitive perspective): • Office of Mngt. & budget – cost benefit analysis • Indian – political economy considerations

20. Possible research areas II • Soft Law Approaches: • Private co driven codes of conduct and research standards – e.g. Dupont – also study similar initiatives in other sectors and how far have they shaped hard law or substituted for hard law • International regulatory impetus: • WHO, UNEP, WTO (“collective preference”) • Expert Committees (information requirements) – e.g. IPCC – major differences.

21. Possible research areas III • Agricultural biotechnology and Nanotechnology: Similarities and differences – could shape regulatory structures and consumer perceptions. • Military applications of nanotechnology: • Massive area of investment – will also to an extent shape regulatory structures – secrecy • Regulatory certainty is imperative – huge investment – minimize the risks – could either be soft or hard law

22. Thank You