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.


Innovative and Flexible Solutions for an End-to-End Patient-Centric, Lean Supply Chain

The trend toward crafting patient-centric clinical trials hold great promise in supporting patients’ willingness and ability to participate in important clinical research. This webinar will explore how recent innovations in forecasting, supply pooling, decentralized processing, labeling, demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

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

Bluebird Bio says the launch of Zynteglo, its first gene therapy, will not occur until 2020 while it tightens up its manufacturing processes.

Catalent is buying a site in Italy from Bristol-Myers Squibb that handles biologics along with old-school solid dose production.

Here is some more manufacturing news from the week.