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Provisions of Generic Drugs under Section 3(d) of Indian IP Act:What does Data from the Backward States Reveal?


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1 Department of Humanities and Social Sciences, Indian Institute of Technology, Patna 801103, Bihar, India
     

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The provisions of section 3(d) of the Indian Patent Act, 1970, were designed to promote and protect the manufacturing of low cost generic medicines in the country. Along with other changes and amendments, they were assumed to benefit the states equally without taking into account the inter-state economic inequalities. The provisions were set forth to secure production of inexpensive generic drugs for easy accessibility at affordable prices across the states. The paper assumes states whose per capita net state domestic product is lower than the per capita net national product, and thus do not get full benefit of inexpensive generic drugs. The section patronises domestic generic drug manufacturers and users from coercive provisions of Trade Related Aspects of Intellectual Property Rights Agreement and foreign patent holder’s aggressive monopoly price. However, it does not guarantee the availability of price effective generic drugs for the people of backward states. Hence, some states need additional attention to make the generic drugs affordable and accessible. The paper has investigated into the intra-molecular price variation of generic drugs and its impact on their affordability in backward states. It aims to find out whether all Indian states equally benefit from the IP Act, or some states are unable to reap its benefit because of the lack of proper policy measures. The analysis is based on both descriptive and analytical methods. It has applied ratio analysis with the data on per capita net state domestic product (proxy of the purchasing capacity) of selected backward states with price data of generic drugs prescribed for major death-causing diseases.
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  • A Model Quality Assurance System for Procurement Agencies (2007), Retrieved from http://apps.who.int/medicinedocs/en/d/Js14866e/
  • Ali, F., R. Sudarsan, S.V. Raman and John, Roshan (2018), Pharmaceutical Patent Grants in India: How our Safeguards against Cvergreening have Failed and Why the System must be Reformed, Acceessibsa, Retrieved from https://accessibsa.org
  • Asian Development Bank (2018), Asian Development Outlook 2018 Supplement: The Outlook Remains Stable, Retrieved fromhttps://www.adb.org/publications/ado-supplement-july-2018
  • Balarajan, Y., S. Selvaraj and S. Subramanian (2011), Health Care and Equity in India, The Lancet, 377(9764): 505–515, doi: 10.1016/s0140-6736(10)61894-6
  • Bhattacharya, B. and S. Sakthivel (2004), Regional Growth and Disparity in India: Comparison of Pre- and Post-Reform Decades, Economic and Political Weekly, 39(10): 1071-1077, Retrieved from http://www.jstor.org/stable/4414738
  • Deaton, A., and J. Dreze (2002), Poverty and Inequality in India: A Re-Examination, Economic and Political Weekly, 37(36): 3729-3748, Retrieved from http://www.jstor.org/stable/4412578
  • Despite Available Funds, 581 Million in These Nine States Have to Endure India's Worst Healthcare (03.07.2017), Retrieved from https://thewire.in/health/despite-funds-581-million-in-these-nine-states-have-to-endure-indias-worst-healthcare
  • Dheeraj Kumar vs. The State of Bihar (2018), Retrieved fromhttp://indiankanoon.org/doc/66243988/
  • Dholakia, Ravindra H. (2003), Regional Disparity in Economic and Human Development in India. Economic and Political Weekly,38(39): 4166-4172, Retrieved from http://www.jstor.org/stable/4414081
  • Drugs (Prices Control) Order (2013), [Gazette of India, Extraordinary, Part II, Section 3, Subsection (ii)] (2013, May 15), Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), India, New Delhi.
  • Drugs Categorized by Medical Condition (n.d.), Retrieved from https://www.drugs.com/medical_conditions.html
  • Ghosh, Abantika (2018), How Are Drug Prices Regulated? The Indian Express, 28 June 2018, indianexpress.com/article/explained/how-are-drug-prices-regulated-5236248/.
  • Handbook of Statistics on the Indian Economy (2017-18), Reverse Bank of India, Mumbai.
  • Healthcare in India: Nine Poorest States' Budgets Lie Unspent, 581 million affected by Inadequate Infrastructure (2017, July 03), Retrieved from https://www.firstpost.com/india/healthcare-in-india-nine-poorest-states-budgets-lie-unspent-581-million-affected-by-inadequate-infrastructure-3769509.html
  • India Brand Equity Foundation (2018), [Pharmaceuticals].
  • India States Briefs (Feb., 2018), Retrieved from http://www.worldbank.org/en/news/feature/2016/05/26/india-states-briefs
  • India, CSO, Ministry of Statistics and Programme Implementation, Government of India, (2015), Manual on Health Statistics in India, Delhi: Government of India.
  • India, Ministry of Law and Justice, Legislative Department (2005), The Patents (Amendment) Act, 2005 no. 15 of 2005 (Section 1 Ed., Vol. PART II), Delhi: Government of India.
  • Indian Patent Act, 1970. Retrieved from http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf
  • Jayantha Kumaran, K. (2010), Economic Reforms and Income Convergence/Divergence in Regional India. Indian Economic Review, 45(1), new series, 29-48. Retrieved fromhttp://www.jstor.org/stable/29793952
  • Joe, W., U. Mishra, and K. Navaneetham (2008), Health Inequality in India: Evidence from NFHS 3, Economic and Political Weekly, 43(31): 41-47, Retrieved from http://www.jstor.org/stable/4027780
  • John, D. (2018, September 12), Why India's Poor Buy Essential Medicines from Private Pharmacies, Retrieved from https://www.indiaspend.com/why-indias-poor-buy-essential-medicines-from-private-pharmacies-86299/
  • Kharas, H., K. Hamel and M. Hofer (2018, June 19), The Start of a New Poverty Narrative, Retrieved from https://www.brookings.edu/blog/future-development/2018/06/19/the-start-of-a-new-poverty-narrative/
  • Kumar, R. (2018), No Generic Drug Stores in Six Out of Nine Government medical college hospitals in Bihar, Retrieved from https://www.hindustantimes.com/patna/no-generic-drug-stores-in-six-out-of-nine-govt-medical-college-hospitals-in-bihar/story-YHi4jNEPPWQywApU8x659L.html
  • Livemint (2017, November 29), How to free Indians from the Medical Poverty Trap, Retrieved from https://www.livemint.com/Opinion/q2vgtlzFzeaSFM6cnvWwYL/How-to-free-Indians-from-the-medical-poverty-trap.html
  • National Pharmaceutical Pricing Authority (2018), Retrieved from http://www.nppaindia.nic.in/wp-content/uploads/2018/10/Ceiling-Prices-Of-Scheduled-Formulations-Under-Dpco-2013-As-On-13.08.2018.pdf
  • National pharmaceutical pricing authority [The Status of cases of overcharging amount under DPCO 1995 & 2013] (30th September, 2018), Delhi, India.
  • NITI Aayog's Health Index: Kerala on Top; Rajasthan, Uttar Pradesh among worst performers. (2018), Retrieved from https://www.downtoearth.org.in/news/health/niti-aayog-s-health-index-kerala-on-top-rajasthan-uttar-pradesh-among-worst-performers-59663
  • Novartis AG vs. Union of India (2013), Retrieved from https://www.sci.gov.in/jonew/judis/40212.pdf
  • Pal, P. and J. Ghosh (2007), Inequality in India: A Survey of Recent Trends, New York: United Nations.
  • Population Reference Bureau (2017), 2017 World Population Data Sheet [Press release], Retrieved from worldpopdata.org
  • Ramachandran, A., S. Ramachandran, C. Snehalatha, C. Augustine, N. Murugesan, V.Viswanathan, . . . , R. Williams (2007), Increasing Expenditure on Health Care Incurred by Diabetic Subjects in a Developing Country: A Study from India, Diabetes Care, 30(2): 252-256, doi:10.2337/dc06-0144
  • Rao, M., R. Shand and K. Kalirajan (1999), Convergence of Incomes across Indian States: A Divergent View, Economic and Political Weekly, 34(13): 769-778, Retrieved from http://www.jstor.org/stable/4407797
  • Rao, M.G. and M.G. Choudhary (2008), Inter-State Equalisation of Health Expenditures in Indian Union, National Institute of Public Finance and Policy, Delhi.
  • Rao, O. (2017), Why 581 Million Indians Endure India's Worst Healthcare, Retrieved from https://archive.indiaspend.com/cover-story/why-581-million-indians-endure-indias-worst-healthcare-51234
  • Ray, T. (2012), Panel Discussion on Counterfeiting Pharmaceuticals: A Crime against Humanity, in CII 6th International Conference on Anti-counterfeiting & Anti-piracy, September 6 & 7, 2012 – Mumbai, Retrieved from https://www.indiaoppi.com/sites/default/files/PDF%20files/Counterfeiting%20Pharmaceuticals%20-%20A%20crime%20against%20humanity_jsdfkjk588.pdf
  • Retrieved from http://nppaimis.nic.in/nppaprice/pharmasahidaamweb.aspx
  • Retrieved from http://www.nppaindia.nic.in/en/utilities/list-of-notified-prices/dpco-2013/
  • Retrieved from http://www.nppaindia.nic.in/overcharging/overchargingstat2018.html
  • Retrieved from http://www.nppaindia.nic.in/overcharging/overchargingstat2018.html
  • Retrieved fromhttp://wdi.worldbank.org/table/4.2
  • Sinha, P. K., A. Sahay and S. Koul (n.d.), Development of a Health Index of Indian States, Retrieved from https://www.indiaoppi.com/sites/default/files/PDF%20files/Development%20of%20a%20Health%20Index%20of%20Indian%20States.pdf
  • Srinivasan, S. (2011), Medicines for All, the Pharma Industry and the Indian State, Economic and Political Weekly, 46(24): 43-50. Retrieved from http://www.jstor.org/stable/23018245
  • Subramanian, S., I. Kawachi and G. Smith (2007), Income Inequality and the Double Burden of under- and over-nutrition in India, Journal of Epidemiology and Community Health (1979),61(9), 802-809, Retrieved from http://www.jstor.org/stable/40665490 The Constitution of India (2015), Retrieved from https://www.iitk.ac.in/wc/data/coi4March2016.pdf
  • The Drug Inspector vs Amruthlal (2016), Retrieved from The Drugs Inspector vs. Amruthlal on 23 September.
  • Universal Human Rights Declaration, Retrieved from http://www.un.org/en/udhrbook/pdf/udhr_booklet_en_web.pdf
  • Virmani, A. (2008), Growth and Poverty: Policy Implications for Lagging States. Economic and Political Weekly, 43(2): 54-62, Retrieved from http://www.jstor.org/stable/40276903
  • Vivek, V. (2017), Indians Sixth Biggest Private Spenders on Health Among Low-Middle Income Nations, Retrieved from http://archive.indiaspend.com/cover-story/indians-sixth-biggest-private-spenders-on-health-among-low-middle-income-nations-78476
  • Watal, J. (2000), Access to Essential Medicines in Developing Countries: Does the WTO TRIPS Agreement Hinder It? Science, Technology and Innovation. Discussion Paper No. 8, Center for International Development, Harvard University, Cambridge, MA, US.

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  • Provisions of Generic Drugs under Section 3(d) of Indian IP Act:What does Data from the Backward States Reveal?

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Authors

Mrityunjay Kumar
Department of Humanities and Social Sciences, Indian Institute of Technology, Patna 801103, Bihar, India
Nalin Bharti
Department of Humanities and Social Sciences, Indian Institute of Technology, Patna 801103, Bihar, India

Abstract


The provisions of section 3(d) of the Indian Patent Act, 1970, were designed to promote and protect the manufacturing of low cost generic medicines in the country. Along with other changes and amendments, they were assumed to benefit the states equally without taking into account the inter-state economic inequalities. The provisions were set forth to secure production of inexpensive generic drugs for easy accessibility at affordable prices across the states. The paper assumes states whose per capita net state domestic product is lower than the per capita net national product, and thus do not get full benefit of inexpensive generic drugs. The section patronises domestic generic drug manufacturers and users from coercive provisions of Trade Related Aspects of Intellectual Property Rights Agreement and foreign patent holder’s aggressive monopoly price. However, it does not guarantee the availability of price effective generic drugs for the people of backward states. Hence, some states need additional attention to make the generic drugs affordable and accessible. The paper has investigated into the intra-molecular price variation of generic drugs and its impact on their affordability in backward states. It aims to find out whether all Indian states equally benefit from the IP Act, or some states are unable to reap its benefit because of the lack of proper policy measures. The analysis is based on both descriptive and analytical methods. It has applied ratio analysis with the data on per capita net state domestic product (proxy of the purchasing capacity) of selected backward states with price data of generic drugs prescribed for major death-causing diseases.

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DOI: https://doi.org/10.21648/arthavij%2F2019%2Fv61%2Fi4%2F191461