两款印度药物被暂停进口到中国

Core Viewpoint - The National Medical Products Administration (NMPA) of China has suspended the import, sale, and use of two drugs produced by Indian manufacturers due to quality control issues, impacting the market for Alzheimer's and allergy medications [3][5]. Group 1: Drug Suspension Details - The two suspended drugs are the Cabalistine Tartrate Capsules from Sun Pharmaceutical Industries Limited, used for treating mild to moderate Alzheimer's disease, and the Chlorpheniramine Maleate raw material from Supriya Lifescience Ltd., commonly used in cold medications [3][4]. - Sun Pharmaceutical's Cabalistine Tartrate Capsules were found to have quality management deficiencies, including inadequate risk assessment for batches exceeding standards and failure to prevent contamination during production [3][5]. - Supriya Lifescience's Chlorpheniramine Maleate raw material was suspended due to non-compliance with production quality management standards, including failure to ensure that each batch met regulatory requirements and inadequate facility management [5][6]. Group 2: Impact on the Industry - The suspension of Supriya Lifescience's raw material will not only affect the company but also Chinese pharmaceutical companies that use this raw material in their cold medications [5][6]. - This is not the first instance of Supriya Lifescience's Chlorpheniramine Maleate being suspended; it faced a similar suspension in March 2020 due to non-compliance with production quality management standards [5][6]. - The NMPA has mandated that any formulations produced using the suspended raw material must not be released, and companies must conduct investigations and implement risk control measures for already released products [6].