Bulk drugmaker Chongiqing Daxin has lost its license to export drugs to India by refusing to let Indian officials inspect its facility. On its maiden inspection trip to the People's Republic, a three-member team from the Central Drugs Standard Control Organization (CDSCO) was shut out just the one time and completed five other inspections. That brings to ten the number of canceled registration certificates and related import licenses of Chinese companies.
The decision to audit Chinese drug manufacturing units was made after inspections of the India-based facilities of those drugmakers. Poor product quality and failure to comply with good manufacturing practices were cited.
Based on those findings, the Drug Controller General of India shortlisted 11 Chinese manufacturing units for inspection. It had just received an OK from the Health Ministry to make inspections beyond national borders.
India is the largest importer of Chinese bulk drugs, reports Times of India. Nearly half of the 272 bulk drug manufacturers registered in India are Chinese companies. Italy is the second largest, at 55 registered companies.
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