The Shanghai Medical Products Administration (SMPA) has revoked the winning bid of India-based Sun Pharmaceutical Industries Ltd. for its prostate cancer drug bicalutamide in the fifth round of China’s national volume-based procurement (VBP) program. This decision follows random inspections that revealed Sun Pharma’s product failed to meet import drug regulations on loss on drying. SMPA has notified the company to halt sales and recall batches from the market, with plans to investigate the issue further.
Background
Last October, Sun Pharma secured a contract worth RMB 32 million (USD 4.77 million) in the fifth VBP round, offering bicalutamide at RMB 195.16 (USD 29) per unit, a 75% price cut. This was Sun Pharma’s only VBP – winning product. Hisun Pharma, Zhendong Pharma, and Fosun Pharma, other manufacturers of bicalutamide, will now be eligible to supply affected provinces.-Fineline Info & Tech
