1. Chinese regulators have disqualified over 10 drug and medical-device companies from national bulk-procurement programs in 2025 after finding serious production or quality-management defects, highlighting rising safety concerns in a system designed to cut medical costs [para. 1]. The latest case involves Shandong Beida Gaoke Huatai Pharmaceutical Co., whose production line for amiodarone hydrochloride injection was suspended due to serious deficiencies, including inadequate investigation of production deviations and insufficient risk-control measures [para. 2][para. 3].2. The National Joint Drug Procurement Office revoked the company’s winning-bid status for the product in the ninth round of centralized procurement and placed it on a “violation list,” barring it from applying to participate in state-organized procurement from June 2026 to December 2027 [para. 4]. Other companies stripped of winning-bid status include Harbin Liqiang Pharmaceutical Co., Chengdu Tiantaishan Pharmaceutical Co., and Weifang Zhongshi Pharmaceutical Co., with violations spanning drugs and medical consumables such as ureteral access guidewires and balloon dilation catheters [para. 5][para. 6][para. 7].3. Under China’s 2014 guidelines, a serious defect is a significant departure from Good Manufacturing Practice (GMP) that could harm users [para. 8]. Health-law professor Deng Yong noted that production deviations typically involve materials management, production processes, or quality control—including insufficient ingredients, improper storage, or inaccurate testing [para. 9][para. 10].4. The disqualified products are mainly from the 11th round of drug procurement and the sixth round of medical consumable procurement. Separately, among over 1,600 products used in the first nine rounds, nine drugs were disqualified due to quality risks [para. 11]. These repeated problems point to weaknesses in consistency evaluation and postmarket regulation [para. 12].5. A former researcher at a multinational pharmaceutical company said that generic drugs passing consistency evaluations often fail due to GMP compliance issues, with smaller Chinese drugmakers lacking regulatory discipline. Another risk is that companies may alter production processes after approval to cut costs, with localized oversight leaving room for protectionism [para. 13][para. 14][para. 15][para. 16].6. Since the 11th round in 2025, authorities have tightened quality controls, requiring selected drugs to be produced on GMP-compliant lines with no violations in the prior two years [para. 17]. In June 2025, China launched the 12th round of centralized procurement, covering 65 products and adding three quality requirements: proof of overseas inspections, no packaging downgrades, and annual quality reviews [para. 18][para. 19].7. Li Jiangning, head of the drug-supervision department at the National Medical Products Administration, said in April 2025 that regulators are conducting full-coverage GMP sampling of selected products, particularly those with steep price cuts or difficult production processes. These inspections have covered 490 products and over 800 selected companies across the first 11 rounds [para. 20].AI generated, for reference only