National Medical Products Administration: Suspension of import, sales, and use of raw material colchicine from Alkaloids Bioactives Private Limited and Alchem International Private Ltd.

Recently, the State Drug Administration organized on-site inspections of the raw materials of galanthamine by Alkaloids Bioactives Private Limited and Alchem International Private Ltd. Upon investigation, both of the aforementioned companies had deficiencies in their change management during the production process of the raw materials of galanthamine. They did not obtain approval or file for changes according to the regulations of China after the drugs were on the market, which does not comply with the requirements in the "Drug Production Quality Management Specification" of China. The State Drug Administration has decided to take the following actions: 1. Suspend the importation of the aforementioned raw materials, and the drug supervision and management departments at various ports will temporarily stop issuing import clearance documents for these raw materials. 2. Adjust the status of the aforementioned raw materials in the "Raw Material Registration Information" of the Drug Evaluation Center of the State Drug Administration to "I." 3. The aforementioned raw materials are not allowed to be sold domestically or used in the production of drug formulations. The formulations produced with these raw materials must not be released for sale; if the formulations have already been released for sale, the holder of the drug marketing authorization should immediately conduct an investigation and evaluation, and take necessary risk control measures based on the evaluation results.