America’s pharma sector has asked US trade representative to continue to keep India on its priority watch list (PWL) which includes countries that are alleged violators of US patent laws, claiming that the environment on the grounds remains “challenging” in India. Among the key issues of concerns for the US pharma sector in India are unpredictable IP environment, high tariffs and taxes on medicines, regulatory data protection failure discriminatory and non-transparent market access policies and unpredictable environment for clinical research. Pharmaceutical research and manufacturers of America (PhRMA), in a submission requested US trade representative to continue to keep India on the Priority Watch List in 2017.

India’s IP regime

We urge USTR, to provide an opportunity for a meaningful assessment of India’s IP regime through an OUT-OF-CYCLE review, so that the US government can evaluate progress on theses important issues and dedicate the required bilateral attention necessary to translate India’s committement into substantive and real policy change that addresses the IP and market access barrier confronted by US business in India. Continued attention to IP and market access barriers in India has sent a strong signal of the importance of this issue to bilateral relationships, has fueled constructive industry-government dialogue, and has been critical in preventing further deterioration of innovation environment in that country. Nevertheless, many of the same issues remain and no meaningful action has been taken to address the unpredictability in IP protection and enforcement that remains.

USTR’s special 301 review

PhRMA said, it supports the Indian government ‘s effort to create a stronger business, innovation and healthcare environment through “Make in India “ campaign ,the New Intellectual property right (IPR) policy and forthcoming Nation Health policy. These efforts can advance improved access to healthcare for Indian patient, while driving economic growth by enhancing India’s global competitiveness and improving ease of doing business. However, despite of some positive signs , PhRMAs members still remains concerned about challenging policy environment in India.
They say that pharmaceutical innovators saw positive signs from Indian government in 2016. However these signals have not been translated into real policy and practical change.
“To research, develop and deliver new treatments and cure to patients biopharmaceutical innovators must be able to secure and effectively enforce intellectual property right. “