PhRMA Special 301 Submission 2016 insists that India remains on the Priority Watch List in the USTR Special 301 Report. PhRMA sees India’s progressive Patent Act of 2005 and IP environment as a legal and regulatory barrier to patentability of newer drugs. Also, it repeatedly pushes for the introduction of ‘Data Exclusivity’. Import duties and taxation policy on pharmaceutical products, drug price control policy and clinical research procedures too have been highlighted as key issues of concern.
The submission attempts to present that India’s IPR regime does not welcome pharmaceutical innovations, thereby restricting the access to medicines for Indian patients. PhRMA has high expectation from the draft IPR Policy and is hoping that it will bring Indian IP rules closer to global standards which will lead to foster innovation and investment. Furthermore, PhRMA urges USTR ‘to provide an opportunity for a meaningful assessment of India’s IP regime through an Out-of-Cycle Review’, so that the U.S. government can evaluate India’s working on IP issues and ‘dedicate the required bilateral attention necessary to translate India’s commitment into substantive and real policy change in the IP.