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Two non compliant Indian pharma sites pulled up by UK and French Regulators


Two non compliant Indian pharma sites pulled up by UK and French Regulators

 

United Kingdom: Anu Pharma and Rusan Pharma , two Indian pharmaceutical companies have received notices of non compliance restricting  the  dissemination of their products in Europe from the National Agency for Medicines and Health Products Safety, France and  Medicines and  Healthcare Products Regulatory Agency, UK respectively.

According to Raps ANSM’s inspection of Anu Pharma’s Maharashtra based site brought forth 24 deficiencies, one critical and two major. The complaint regarding  critical deficiency concerned non transfer of 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 applied to all active substances at the site.

Besides this  french inspectors also  found several documents lying in a pile of rubble, including 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 Pharma plans to  request for a hearing with the European Directorate for the Quality of Medicines and HealthCare to review the findings in March.

Meanwhile, findings of an MHRA inspection of Rusan Pharma’s Gandhidham based site stated that the company’s pharmaceutical quality system was not operating properly enough  to ensure patient safety protection. The inspecting agency observed  that the site was still non compliant, especially with regards to data trace ability and security, as well as systems to control contamination and deficiencies in training.



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