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Generics provide a sigh of relief for those who cannot afford the original drugs. While the incidence rate of diseases is on a
high, the price of original drugs is making it increasingly difficult for people across nations to gain accessibility to the drugs.
Under such market circumstances it is a boon for the pharmaceutical companies which can re-engineer the original drug and
can introduce it in the market at lower prices. The US Intellectual Property Law provides for the introduction of generics in the
market through paragraph four challenges and also the paragraph three applications. Indian pharmaceutical companies have
been actively participating in the global market and are reaping the benefits of their manufacturing competencies. In this paper
we would observe the rise of these giants in accordance with the changes in the Indian Intellectual Property Rights regime. We
would observe how these firms dealt with the introduction of drugs in the market as they went along with the changes in the IP
regime in India where TRIPS is being implemented in stages. We would observe the pre-TRIPS, post TRIPS and pre-Product
patent, post-Product patent introduction times. We will also check if the intent behind the introduction of these laws is being
satisfied or not. While the issue of affordability and availability of drugs is being grappled with, the Intellectual Property Law
plays a major role in determining these aspects. We will also deal with how the sections of the law have been altered in order to
be compliant with the TRIPS agreement.
Kama Raju Chitrapu is Fellow from National Academy of Legal Studies and Research (NALSAR) University of Law, Hyderabad with a Masters of Law
and Ph.D., in International Intellectual Property Law Enforcement and Compliance. Currently associated with Wadhwani Centre for Entrepreneurship
Development as a Senior Researcher-IPR. Prior to joining WCED, he worked as a Head & IP Attorney of Confederation of Indian Industry (CII)
Karnataka MSME-IPR Facilitation Cell Mysore as a IP Policy facilitator and trainer for national IP training and Entrepreneurs awareness initiatives
of MSME?s facilitating IPR Information, advisory services, filings, prosecution and capacity building of MSME?. He is enrolled as an Advocate in
the High Court of Andhra Pradesh in 2000 and conducted IP training programs at Sardar Vallabhai Patel National Police Academy (SVPNPA), AP
Judicial Academy, AP Police Academy, NAARM, NALSAR, IIIT, BITS Pilani Hyderabad Campus for various IP Stakeholders.
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