Regulatory Focus™ > News Articles > UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

Posted 04 April 2016 | By Zachary Brennan 

UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe.

In February, ANSM inspected Anuh Pharma’s Maharashtra-based site and uncovered 24 deficiencies, including one that was critical and two that were major. The critical deficiency was linked to the fact that Anuh does not transfer information on the original manufacturers of at least eight active substances to the user of the active substances.

“Moreover, a non EU-GMP compliant source for Azithromycin (NCF/010/RO, Hebei Dongfeng Pharmaceutical Co., Ltd, China) was micronized and directly exported to Europe under the manufacturer name Anuh Pharma,” ANSM inspectors said. The regulators also noted that the noncompliance rating applies to all active substances at the site.

In addition to the critical deficiency, French inspectors found several documents “within a pile of rubble,” including an original batch repacking record, which should have been placed under retention, and a large number of purchase orders from 2013 for active substances.

“The findings reveal a critical noncompliance of the quality system of the company as a whole. Moreover, due to the severe lack of transparency of the company regarding its manufacturing activities, there is no assurance as regards to the origin of every batch of active substances claimed to have been manufactured by the company at the Boisar site,” ANSM said.

Anuh said in a statement from March that it’s requesting a hearing to ask the European Directorate for the Quality of Medicines and HealthCare to review the findings.

MHRA Inspection

Meanwhile, an MHRA inspection of Rusan Pharma’s Ghandhidham-based site from January found that the company’s pharmaceutical quality system is still not operating appropriately to ensure patient safety was protected.

This is MHRA’s first inspection of the site since banning imports to the EU from it in November 2012. MHRA said the site is still noncompliant, particularly with regard to data traceability and security, as well as systems to control contamination and deficiencies in training.

MHRA also took issue with another Indian pharmaceutical company’s manufacturing site last month -- Marksans Pharma’s Goa-based site.

EudraGMDP


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