China’s National Medical Products Administration (NMPA) announced on January 26 that it has suspended the import, sale and use of two pharmaceutical products manufactured in India after regulatory inspections uncovered significant deficiencies in production quality and compliance with Chinese standards.
According to official notices, Rivastigmine Hydrogen Tartrate Capsules, produced by Sun Pharmaceutical Industries Limited, widely used in the treatment of dementia associated with Alzheimer’s disease and Chlorpheniramine Maleate Active Pharmaceutical Ingredient (API) produced by Supriya Lifescience Ltd., a common antihistamine raw material, are affected by this decisions.
The actions follow NMPA-led inspections, a remote audit for the rivastigmine capsules and a site inspection for the chlorpheniramine API which identified serious quality management and manufacturing lapses.
For the Rivastigmine Hydrogen Tartrate Capsules, the regulator found that the manufacturer’s quality management systems were inadequate in identifying and controlling risks affecting several batches already on the market. The inspection also flagged weaknesses in contamination control and failure to adhere to the Pharmacopoeia of the People’s Republic of China, practices required under China’s Good Manufacturing Practice (GMP) standards.
In the case of the chlorpheniramine API, NMPA inspectors discovered that the company failed to ensure consistent compliance with regulatory and registration requirements for each released batch. Additional concerns included poor site control, with inadequate measures to prevent insects and other contaminants from entering production areas.
Under relevant provisions of China’s Drug Administration Law and Regulations on Overseas Inspections of Drugs and Medical Devices, the NMPA has ordered:
- Immediate suspension of import clearance for both products, with customs authorities instructed not to issue import permits.
- Suspension of domestic sales and use of the affected products nationwide.
- For the API, the product’s registration status has been changed to a category indicating it did not pass joint review with finished dosage forms, effectively barring its use in drug manufacturing in China.
Companies with existing drug products incorporating the suspended API are also required to immediately investigate and assess potential risks, and implement appropriate control measures.
