China NMPA Drug Inspection - Preparation Room of Macheng Traditional Chinese Medicine Hospital - Fritillaria and Asparagus Cough Syrup

The "Hubei Province Drug Quality Announcement (2017, Issue 2)" reports on drug quality sampling inspections conducted by Hubei provincial and local food and drug administration departments during the second quarter of 2017. These inspections operated under the regulatory framework of the "Drug Administration Law of the People's Republic of China," alongside various editions of the "Chinese Pharmacopoeia" and other national and provincial drug standards.The inspections identified 30 batches of drugs from numerous companies, including Chengdu Jinhua Pharmaceutical, Wuhu Kangqi Pharmaceutical, Shandong Yikang Pharmaceutical, and Qingdao Huanghai Pharmaceutical, among others, that failed to meet established quality standards. Key violations spanned a range of quality control deficiencies, such as failures in dissolution, presence of related substances beyond limits, incorrect content determination, unsuitable pH values, weight variation, and identification test failures. Specific examples included Norfloxacin Capsules, Vitamin K1 Injection, Antiviral Oral Solution, and various Traditional Chinese Medicine preparations, some exhibiting improper moisture levels or packaging issues. Notably, some drugs were identified as counterfeit, containing undeclared substances like Prednisolone Acetate, or had their production denied by the labeled manufacturer, indicating potential illicit sourcing.Local food and drug administration departments are mandated to investigate these non-compliant drugs and associated entities. Required actions include thoroughly tracing the source of problematic drugs, particularly those from unidentified manufacturers or lacking clear purchase channels. Cases involving suspected criminal activity must be promptly referred to public security organs for prosecution, with all findings reported to the Provincial Bureau.