India’s Indoco Remedies cited by U.K. drug regulators for manufacturing issues

Indian flag
U.K. regulators cited three critical and four major observations following an inspection of the plant. (Yann Forget / Wikimedia Commons)

Indian drugmaker Indoco Remedies was cited by U.K. drug regulators for a number of issues at its manufacturing facility in Goa.

The observations, posted on the EudraGMP website, cited three critical and four major observations following an inspection of the plant from March 14-16. Indoco Remedies manufactures solid dosages, liquid orals and external preparations at the facility.

Inspectors from the U.K.’s Medicines and Healthcare products Regulatory Agency found evidence of falsification of data at the plant as well as a quality control failure for recording, investigating and completion of actions relating to unexpected events. The company was also cited for give false and misleading statements to inspectors.

The agency issued a statement of noncompliance and restricted GMP certificate that allows Indoco to continue manufacturing and testing of products considered to be “medically critical or to ensure continuity of supply, as determined by the national competent authority.”

It didn’t issue a recall for batches already released by the company; however, the agency recommended no batches of noncritical product should be supplied to EU markets as long as the statement of noncompliance remains in force.

Suggested Articles

Mylan recalls one lot of the injectable antibiotic daptomycin after discovering particles in a single-dose vial.

Lupin Pharmaceuticals pulled all lots of its extended-release diabetes drug metformin amid carcinogen contamination concerns.

Novartis and Civica Rx are patterning up to shore up supply of six key generic injectables used in acute care settings in hospitals.