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Nanotechnology Regulation in India: Framework for Exploring Risks and Opportunities. Nupur Chowdhury Regulating Nanotechnology ISA Convention March 2006. Format of Presentation. Indian State: Regulatory Impetus for new emerging technologies

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nanotechnology regulation in india framework for exploring risks and opportunities

Nanotechnology Regulation in India: Framework for Exploring Risks and Opportunities

Nupur Chowdhury

Regulating Nanotechnology

ISA Convention March 2006

format of presentation
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
indian state and emerging technologies
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
regulating icts and biotechnology
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
regulating icts and biotechnology5
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
regulating nanotechnology
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
research investment in nano technology
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.
research investment in nano technology ii
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
research investment in nano technology iii
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
government initiatives
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
regulatory imperatives
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
regulatory concerns
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
existing legislations and judicial prescriptions
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
legislative framework
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
legislative framework ii
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
judicial prescriptions
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
few broad conclusions
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
conclusions ii
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
possible research areas
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
possible research areas ii
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.
possible research areas iii
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