Intellectual Property Right in India- A Review
The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, diagnostics, cosmetics and devices in the country. Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process, the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. Patent strategy provides a check list for developing comprehensive patent strategies for the company.
2. Basant R. Intellectual property rights regimes: comparison of pharma prices in India and Pakistan. Econ Polit Wkly [Internet]. 2007 [cited 2019 Jun 16]; 42(39):3969-77. Available from:
https://www.dovepress.com/ by 220.127.116.11 on 20-Dec-2018
3. Horner R. The impact of patents on innovation, technology transfer and health: a pre-and post-TRIPs analysis of India’s pharmaceutical industry. New Polit Econ [Internet]. 2014 [cited 2019 Jun 18]; 19(3):384-406. Available from:
4. Gabble R, Kohler JC. To patent or not to patent? the case of Novartis’ cancer drug Glivec in India. Global Health [Internet]. 2014 Jan 06 [cited 2019 Jun 16]; 10:3. Available from:
5. Planning Commission, Government of India. Report of the Working Group on Indian Pharmaceutical Industry for the Twelfth Five Year Plan (2012–2017); 2012.
6. Akhtar G. Indian pharmaceutical industry: an overview. IOSR J Humanit Soc Sci. [Internet]. 2013 [cited 2019 Jun 16]; 13(3):51-66. Available from:
www.iosrjournals.org/iosr-jhss/papers/Vol13-issue3/H0 1335166. pdf?id=3395.
7. Haley GT, Haley UCV. The effects of patent-law changes on innovation: the case of India’s pharmaceutical industry. Technol Forecast Soc Change [Internet]. 2012 [cited 2019 Jun 17]; 79(4):607-19. Available from:
8. Bedi N, Bedi PMS, Sooch BS. Patenting and R&D in Indian pharmaceutical industry: post-TRIPS scenario. J Intellectual Property Rights [Internet]. 2013 [cited 2019 Jun 27]; 18(2):105-10. Available from:
9. Department of Pharmaceuticals. Annual Report (2014–2015). New Delhi: Ministry of Chemicals and Fertilizers, Government of India; 2015.
10. Balarajan Y, Selvaraj S, Subramanian SV. Health care and equity in India. Lancet [Internet]. 2011 [cited 2019 Jun 26]; 377(9764):505–515. Available from:
11. Duggal R. Healthcare in India: changing the financing strategy. Soc Policy Adm [Internet]. 2011 [cited 2019 Jun 26]; 41(4):386-94. Available from:
12. Selvaraj S, Karan AK. Deepening health insecurity in India: evidence from national sample surveys since 1980s. Econ Polit Wkly [Internet]. 2009 [cited 2019 Jun 21]; 44(40):55-60. Available from:
13. MoHFW [Internet]. National Health Policy. New Delhi: Ministry of Health and Family Welfare, Government of India; 2002 [cited 2019 Jun 22]. Available from:
14. Planning Commission, Government of India. [Internet]. Twelth Five Year Plan (2012–2017): Social sectors (Vol III). New Delhi: Sage India; 2012:4 [cited 2019 Jun 21]. Available from:
15. Sengupta, Amit for Jan Swasthya Abhiyan [Internet]. Universalising Health Care for All; 2012 [cited 2019 Jun 21]. Available from:
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