(Yicai) Jan. 27 -- China has suspended the import, sale, and use of an Alzheimer's treatment and an active pharmaceutical ingredient used in cold medicines made in India because of deficiencies in the manufacturers’ quality-control and plant hygiene practices.

Imports of Sun Pharmaceutical Industries' rivastigmine tartrate capsules, used to treat mild to moderate Alzheimer's disease, and Supriya Lifescience's chlorpheniramine maleate API, which is commonly used in compound cold medicines, have been banned, the National Medical Products Administration announced late yesterday.

Sun Pharma's quality management department performed inadequately during production of rivastigmine, the NMPA said, citing insufficient risk assessments for certain marketed batches found to have excessive impurities and a failure to take timely and effective corrective action.

The Mumbai-based company’s contamination-control measures during manufacturing also failed to meet China’s pharmaceutical quality management requirements, the regulator added.

Supriya did not ensure that the production and testing of every released batch of chlorpheniramine maleate API complied with regulatory and registration standards, the NMPA said. The watchdog also found that the production site lacked effective safeguards to prevent insects and animals from entering, in violation of China’s drug manufacturing and approval rules, it said.

Supriya, also based in Mumbai, is one of the world's top five makers of chlorpheniramine maleate API, according to the findings of a survey by Hengce Research. The halt to imports will likely impact the production and sales of Chinese cold medicine makers.

By order of the NMPA, Supriya’s chlorpheniramine maleate API may not be used in China to produce pharmaceutical preparations, and finished products made with the ingredient will not be cleared for sale. For products already on the market, marketing authorization holders must immediately conduct checks and risk assessments and implement necessary risk control measures based on their findings.

This is the second time China has banned imports of Supriya's chlorpheniramine maleate API. In March 2020, the NMPA imposed a similar ban after finding that parts of the production process did not comply with Good Manufacturing Practices.

Editors: Tang Shihua, Martin Kadiev