National Medical Products Administration: Suspends Import of Raw Materials from India.

The National Medical Products Administration announced today that a recent on-site inspection of VITAL LABORATORIES PVT. LTD. found that the factory's production of digoxin active pharmaceutical ingredients does not match the declared production process, insufficient research on changes in production process and key parameters, failure to inspect release according to imported registered quality standards, and deficiencies in quality management and quality assurance systems, which do not comply with China's "Drug Production Quality Management Standards" and related requirements for drug-related review and approval. According to relevant regulations such as the "Drug Administration Law of the People's Republic of China," the National Medical Products Administration has decided to, with immediate effect: 1. suspend the import of the above-mentioned active pharmaceutical ingredients, and the drug supervision and management departments at various ports shall suspend the issuance of import clearance documents for these active pharmaceutical ingredient products. 2. Adjust the entry of the above-mentioned active pharmaceutical ingredients in the "Registration Information for Drug Packaging and Auxiliary Materials" at the Drug Evaluation Center of the National Medical Products Administration to "I" in conjunction with the evaluation and approval results for the formulation. 3. The above-mentioned active pharmaceutical ingredients shall not be used in the production of drug formulations, and formulated products produced using these ingredients shall not be released for use. For formulated products that have already been released onto the market, the drug marketing authorization holder shall immediately conduct an investigation and evaluation, and take necessary risk control measures according to the evaluation results.