National Medical Products Administration: Suspend the import of an Indian raw pharmaceutical ingredient

The reporter learned today (the 3rd) from the National Medical Products Administration: Recently, the NMPA organized an on-site inspection of an Indian company (named Cadila Pharmaceuticals Limited) regarding the raw material drug of amlodipine besylate. The registration number of this raw material drug is: Y20190009999; manufacturing address: 294, GIDC ESTATE, ANKLESHWAR, GUJARAT STATE, INDIA. Upon investigation, it was found that some production steps of the above product were actually produced at addresses different from the registered information, and there were multiple unreported changes during production, as well as discrepancies between the actual manufacturing process and the approved process, which do not meet the requirements of China’s “Good Manufacturing Practice for Drugs (2010 Revision)” and related appendix requirements. According to relevant provisions such as Article 99 of the “Drug Administration Law of the People’s Republic of China” and Article 30 of the “Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices,” the NMPA has decided, effective immediately: 1. Suspend the import of the above raw material drug, and the drug supervision departments at each port shall suspend issuing import clearance certificates for this raw material drug. 2. The above raw material drug in the “Raw Material and Packaging Registration Information” of the NMPA Drug Review Center has been adjusted to “I” in the “Joint Review and Approval Results with Formulation,” indicating that it has not passed the joint review and approval with the formulation. 3. The above raw material drug shall not be sold domestically or used for drug formulation production. For formulations produced using the above raw material drug, release shall be suspended; for formulations already on the market, the drug marketing authorization holder shall immediately conduct investigations and assessments, and take necessary risk control measures based on the assessment results. (CCTV News)