The national drug alliance procurement office has released a notification indicating that China Meheco Keyi Pharma Co., Ltd’s ganciclovir failed a production site inspection. As a result, the company will lose its tender within the fifth volume-based procurement (VBP) round. The Hubei Medical Products Administration bureau has suspended the manufacturing and sales of the drug. Additionally, the national drug alliance procurement office has decided to strip Keyi Pharma of its winning bid and blacklist the firm.
Regulatory Actions and Consequences
The company will be ineligible to participate in VBP or centralized tenders from January 9, 2023, to July 8, 2024. This suspension and blacklisting highlight the strict regulatory measures in place to ensure the quality and safety of pharmaceutical products in China. The national drug alliance procurement office will initiate a substitution process, with other qualified winning manufacturers supplying the provinces previously serviced by Keyi Pharma. Specific results of the substitution process will be published separately.
Drug Profile and Market Impact
Ganciclovir is an anti-viral drug used to prevent disease caused by cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. The loss of the VBP bid and the subsequent regulatory actions against Keyi Pharma underscore the importance of maintaining high standards in pharmaceutical production and quality control. This development may impact the supply chain for ganciclovir, necessitating a swift and effective response from other manufacturers to ensure continued availability of the drug for patients in need.
Future Outlook
The actions taken against Keyi Pharma highlight the regulatory body’s commitment to ensuring the quality and safety of drugs in the market. The substitution process will be closely monitored to ensure a smooth transition and continued supply of ganciclovir. This incident serves as a reminder to pharmaceutical companies of the critical importance of adhering to regulatory standards and maintaining robust quality control measures.-Fineline Info & Tech
