1 Indian Manufacturer Banned from Exporting Heart Drug to China Over Safety Violations

China’s drug regulator has suspended imports of digoxin API from Indian firm VITAL LABORATORIES PVT. LTD., citing serious quality control lapses discovered during a recent on-site inspection. The decision, effective April 27, stems from findings that the company’s actual production process deviated from what was officially registered, with insufficient research on key manufacturing changes.

Regulators found that the active pharmaceutical ingredient (API) failed to meet China’s GMP standards, with issues including inadequate quality assurance systems, improper release testing, and unauthorized modifications to critical parameters. These violations conflict with China’s regulatory requirements for drug manufacturing and import oversight.

Digoxin, a cardiac glycoside, is used to treat heart conditions such as atrial fibrillation, atrial flutter, and congestive heart failure. While effective, its safety relies heavily on precise manufacturing controls, making regulatory compliance especially critical.

The National Medical Products Administration (NMPA) has ordered all customs offices to halt clearance for this ingredient and prohibited its use in finished drug production. Additionally, any finished products already released using this API must be investigated immediately by the Marketing Authorization Holders (MAHs), who are required to carry out risk assessments and implement appropriate safety measures.

The digoxin API’s review status on China’s pharmaceutical registry has also been downgraded to “I,” indicating it has failed the joint evaluation process with its related drug products. This move effectively removes the API’s eligibility for use in domestic pharmaceutical manufacturing.

This case underscores China’s zero-tolerance stance on drug safety and its ongoing efforts to tighten import controls on foreign APIs to protect public health.