India’s Generic Drug Blood Concentration Fails Standards—China Urgently Halts Production!

Studies have revealed that the application of Indian-made tomoxetine hydrochloride capsules in the Chinese market has failed to achieve the expected blood drug concentration, leading to the decision of China's National Healthcare Administration to suspend the import, sale and use of the drug. The original product of tomoxetine hydrochloride, a drug used to treat ADHD, has been discontinued in the Chinese market due to market competition. India's Dr Reddy's Laboratory, the country's third-largest generics maker, has suffered similar problems with its generic olanzapine.

Olanzapine is mainly used for the treatment of acute bipolar mania, but there are difficulties in the conversion between the original drug and different generic drugs in the Chinese market. The study, conducted jointly by Xiangya Second Hospital and Ningbo Kangning Hospital, showed that patients switched from Chinese generic drugs to Indian generic drugs, and the blood drug concentration decreased significantly, which may have an impact on treatment effectiveness and drug safety. The researchers suggest that changes in efficacy and tolerance should be closely monitored during the conversion of generic drugs, and recommend that pharmaceutical companies disclose pharmacological and bioequivalence data and develop appropriate clinical evaluation and monitoring guidelines.