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The Data Exclusivity Debate In India: Time For A Rethink?, Prashant Reddy T.
The Data Exclusivity Debate In India: Time For A Rethink?, Prashant Reddy T.
Indian Journal of Law and Technology
Data exclusivity or regulatory marketing exclusivity is a concept that has been subject to much debate in the Indian context – with specific reference to the Indian pharmaceutical and agro-chemical industries. This debate has been carried on in the backdrop of obligations under the TRIPS as well as the Indo-EU Free Trade Agreement. In this paper, the author discusses the concept of data exclusivity in the light of the existing regulatory regime for pharmaceuticals and agro-chemicals in India. He also examines various Committee reports to glean the Indian stance on data exclusivity for agro-chemicals as well as pharmaceuticals and the …
Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?, Dipika Jain
Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?, Dipika Jain
Indian Journal of Law and Technology
The National Pharmaceutical Policy was approved by the Cabinet and notified in 2012. Based on this policy, a new Drugs Price Control Order was notified in May, 2013. As a result, several drugs will come within the ambit of price control under the National list of Essential Medicines (NLEM). The primary purpose of NLEM is to facilitate the rational use of medicines which will allow for cost effective, safe and drugs with efficacy. This paper critically evaluates the provision on exclusion of patented drugs in the recent National Pharmaceutical Policy, 2012 from the Drug Pricing Policy for five years. The …
India’S Tryst With Trips: The Patents (Amendment) Act, 2005, Shamnad Basheer
India’S Tryst With Trips: The Patents (Amendment) Act, 2005, Shamnad Basheer
Indian Journal of Law and Technology
The Patents (Amendment) Act, 2005 introduces pharmaceutical product patents in India for the first time. This Act attempts to balance out competing interests of a variety of stakeholders, including domestic generic medicine producers, foreign multinational pharmaceutical companies and civil society groups concerned with access to medicines. Although this dexterous manoeuvring around competing interests deserves praise, the net result of such a compromise has been a lack of clarity in the law. While highlighting the key aspects of the 2005 amendments and this lack of clarity, this article also focuses on the vexed issue of the likely impact of the new …