AMCHAM’s Pharmaceuticals Committee met with U.S. Embassy officials on 3rd August 2018 at the Leela Palace, New Delhi. The meeting was chaired Mr. Sanjiv Navangul, Chairman – Pharma Committee, AMCHAM and Managing Director, Janssen and Ms. Jyotsna Ghoshal, Co-Chair – Pharma Committee, AMCHAM and Executive Director, Public Policy and Corporate Affairs, MSD. U.S. Embassy officials present included Mr. Darrel Ching, Deputy Minister Counselor for Commercial Affairs, Ms. Komal Kalha, Senior Counsel, US Patent & Trademark Office, Dr. Vid Nukala, Senior Advisor – Biomedical Science & Technology and Health, Office of Global Affairs (OGA), Health and Human Services (HHS), Ms. Bhavna Vishwakarma, Commercial Specialist and Ms. Shilpi Jha, US Patent & Trademark Office.
The objective of the meeting was to discuss continued collaboration between U.S. industry and the U.S. Embassy regarding pharma. Some of the topics discussed included DPCO guidelines, difference between scheduled formulations and non-scheduled formulations, IPR (notification, compulsory licensing and working of patents), clinical trials (strong regulations for effective CT environment meeting global standards), pricing and Aayushman Bharat, among others. The committee decided to prepare a paper on TICFA (Trade and Investment Cooperation Forum Agreement – an agreement between the U.S. and Bangladesh) to submit to USPTO.
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