BMS - Vakgroep PA (EN)

List of Publications

•Publications in refereed journals: (Completed: 11; Under Review: 3)

1.Multiplicity of Regulatory Pathways and Legal Certainty - A Qualitative assessment of manufacturer perceptions of the marketing authorization of pharmaceuticals in Europe – Under review.

2.Pursuing legal certainty within multilevel regulation: A Qualitative study of stakeholder perception of the marketing authorization of medical devices in Europe – Under review.

3.Expectations from Technology and the Indian State: Comparing Interventions by the Executive and the Judiciary – Under review.

4.Common Market but divergent regulatory practices : Exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products – Forthcoming in Journal of European Integration.

5.Conceptualising Multilevel Regulation in the EU: A Legal Translation of Multilevel Governance?; (2012) Co-authored with Ramses Wessel. European Law Journal, Vol. 18, No. 3, May 2012, pp. 335–357.

6.Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines? (2011) Co-authored with Barbel Dorbeck-Jung. Law and Policy, 33(2) 276-303.

7.Patenting of Micro-organisms in the TRIPS regime: India’s Regulatory Options and the Negotiating Mandate within TRIPS Agreement (2010). GNLU Journal of Law, Development and Politics, 2(1) 58-81.

8.Decision on Bt-Brinjal: Issues of Legal Certainty (2010) Co-authored with Nidhi Srivastava. Economic & Political Weekly, 45(15) 18-22.

9.Regulation of nanomedicines in the EU: distilling lessons from the paediatric and the advanced therapy medicinal product approaches (2010) Nanomedicine, 5(1) 135-142.

10.Regulation of Health Related Nano Applications in India: Exploring the Limitations of the Current Regulatory Design (2009) Co-authored with Nidhi Srivastava. Notizie di Politeia, 25(94) 58-74.

11.Technical Capacity, Policymaking and Food Standards: An Overview of Indian Experience” (2008) Co-authored with Sanjay Kumar. Asian Biotechnology and Development Review, 11(1) 21-41.

12.The legal regime for application of the precautionary principle in India: future directions for the GM regulatory regime” (2007) Co-authored with Santanu Sabhapandit. International Environmental Agreements: Politics, Law and Economics, 7(3) 281-300.

13.Regulatory Supervision of Emerging Technologies: A Case for Nanotechnology in India (2006) Economic & Political Weekly, 41(46) 4730-4732.

14.Unraveling Legal Issues in CDM Implementation in India (2005) Co-authored with Vivek Kumar, Oil, Gas and Energy Law Intelligence, 3(3).

15.Patents Bill: Protecting Indigenous Knowledge (2004), Economic and Political Weekly, 39(46-47) 4984-4986.

•Publications in proceedings of seminars/conferences (Completed: 3 Under Review: 1)

16.Pursuing legal certainty within multilevel regulation: An empirical investigation of manufacturer perceptions of medical device regulation in Europe – paper to be presented in the panel on Health in EU law, policy and governance: uncertainties and hybridity, UACES 42nd Annual Conference, Passau, 3rd – 5th September 2012.

17. European Member States have common objectives in health policy, but there are 27 models”: Exploring Europeanization and regulatory uncertainty in the marketing authorization of medical products. – Paper selected for presentation at the International Seminar on European Regulatory Governance: Developments and Change – to be held on October 27th and 28th, 2011, at Copenhagen Business School. *

18.On India's plunge into Nanotechnology: What are good ways to catch-up? - Co-authored with Shyama Ramani, Roger Coronini, and Susan Reid. Paper presented at the 8th Globelics Conference at Kuala Lumpur, Malaysia, between 1-3 November 2010. **

19.Regulatory lessons from nanomedical regulation – Paper included in the Panel: Governing nanotechnologies: from risk regulation to the governance of innovation II, at the Regulation in the Age of Crisis, Third Biennial Conference of the European Consortium on Political Research - Standing group on Regulatory Governance; held at University College Dublin, between June 17-19, 2010.

•Books and monographs: (Completed: 8)

20.Transnational Regulation of Nanotechnology: Institutional diversity in agenda setting and State support (December 2011) In: Heldeweg, A. H and Kica, E (eds). Regulating Technological Innovation: A Multidisciplinary Approach. Palgrave MacMillan: Basingstoke/Un.

21.Engaging the State in addressing the regulatory challenges of nanomedicine developments in India: Product Safety and Quality” with Nidhi Srivastava (March 2012) in Nanotechnology and Global Sustainability, CRC Press (Taylor Francis).

22. On India's plunge into Nanotechnology: What are good ways to catch-up? (2011) - co-authored with Shyama Ramani, Roger Coronini, and Susan Reid – UNU-MERIT Working Paper – 2011-20. **

23.The (Absence of) Direct Effect of WTO law – Current Developments within the Indian Legal System” (2010) in Direct Effect of WTO Law in the European Community Legal System and in Other Countries, Giappichelli Publishing.

24.Entries on “India”, “Techno-optimism”, “REACH”, “ISO” and “RIVM” (2010) in Encyclopedia of Nanoscience and Society, Sage Reference Publications.

25.People, Parks, and Precaution: The Evolution of the Precautionary Principle in Wildlife Conservation in India” (2005) with Nanki Kaur, CS Silori, and MA Khalid; in Biodiversity and the Precautionary Principle: Risk and Uncertainty in Conservation and Sustainable Use, Earthscan Publications

26.The Principle of Good Governance: Recent Developments in International Law Related to Sustainable Development” (2005) with C E Skarstedt, Recent Developments in International Law Related to Sustainable Development Series, CISDL ((Centre for International Sustainable Development Law)) Working Paper No. 5.

27.Trade and Environment the in WTO: Negotiating positions and future options for India” (2005) co-authored with Sanjay Kumar, RIS (Research and Information Systems for Developing Countries) Discussion Paper, No. 13.

•Book Reviews (Completed: 4)

28.Medical Devices: European Union Policymaking the Implementation of Health and Patient Safety in France, by Christa Altenstetter, European Journal of Risk Regulation , 1, 140-141

29.Technology and Society, Edited Deborah G. Johnson and Jameson M. Wetmore, Cambridge, MA: MIT Press, (2010) Time and Society Review of Books. 19: 410-413.

30.Governing Agro Biodiversity: Plant Genetics and Developing Countries by Regine Andersen, (2010) Political Studies Review, 8(1) 105.

31.Rights, Regulation and the Technological Revolution by Roger Brownsword, (2008) SCRIPTed - A Journal of Law, Technology & Society, 5(3).

•Research Reports (Contribution – Completed:7)

32.Nanotechnology development in India: building capability and governing the technology (2010) TERI Project Report submitted to IDRC.

33.Enhancing Public Health Delivery System in India: Impact of judicial decisions towards access to universal health care (2010) TERI Project Report submitted to SANEI.

34.Report on WIPO (2010) ASIL- Reports on International Organizations, American Society of International Law.

35.State of Play in Sustainable Public Procurement (2007) IISD and TERI Project Report.

36.Rules on Energy Trade and WTO Compliance (2006) with Mitali Dasgupta, GALT Update, 1(1), TERI.

37.CDM Implementation in India – The National Strategy Study (2005) TERI report submitted to the World Bank.

38.Internalizing Traditional Ecological Knowledge in the Application of Precautionary Principle in Natural Resource Management (2005) Briefing Paper, Gene Campaign.