China suspends colchicine imports from two Indian companies

China's top drug regulator on Wednesday announced the immediate suspension of the import, sale and use of colchicine — an anti-inflammatory active pharmaceutical ingredient commonly used to treat gout — produced by two Indian companies, citing violations of Chinese pharmaceutical regulations.

During on-site inspections of the manufacturing facilities of the two companies — Alkaloids Bioactives Private Limited and Alchem International Private Ltd — the National Medical Products Administration found that changes had been made to colchicine production processes without obtaining the required approvals or filings under Chinese laws and regulations.

The administration ordered an immediate halt to all imports of colchicine ingredients from the two companies. The affected products are prohibited from being sold in China or used in the production of pharmaceutical products.

For drug products that have already been released to the market, relevant marketing authorization holders are required to immediately carry out investigations and risk assessments and take necessary measures to control potential risks.