Report by the Secretariat (WT/TPR/S/249):III. TRADE POLICIES AND PRACTICES BY MEASURE: (2) Measures Directly Affecting Imports: (ix) Technical regulations and standards: Pages 68-69, paragraphs 103-105:
The United States understands that individual states in India are asking medical devices companies to provide pricing information and plant master files. These devices are distinct from drugs and typically have U.S. Food and Drug Administration approval when exported from the United States. Do states' regulators under the Drugs and Cosmetics Act have the authority to require this information, or does this authority belong to the central government? Please explain the rationale for requesting pricing and other proprietary information on medical devices, and can this objective be achieved in less burdensome and intrusive ways?
Reply: The information of Plant Master File is required to be submitted to the Central Government at the time of Registration. There is no requirement for submission of Plant Master File to the State Regulatory Authorities for imported medical devices. State authorities may however ask for information in certain cases where they have reasons to ask for such information as a regulatory authority.
