India’s Mercury Laboratories intends to boost its exports but an EMA report shows regulators are not impressed with what the company is doing now.
A newly posted inspection report of one of Mercury’s plants in Jarod, India, found 20 deficiencies, including one critical and six major deficiencies. The plant is not currently shipping products to the European Union and the EMA said it shouldn’t be permitted to do so.
The critical deficiency was tied to authenticity of manufacturing records. Inspectors said production records and quality risk assessment records could not be verified.
The major deficiencies were related to poor manufacturing and process validation that does not assure that Mercury’s drugs consistently meet specifications and quality standards, the report said. There were also concerns about cross contamination.
The EMA has found similar issues with other Indian drugmaker, including some of the largest. A year ago, it found big issues at a Dr. Reddy’s small molecule tablet and capsule formulation facility in Bachupally Village, Telangana. Among other issues, the German inspection team raised questions over how the Dr. Reddy’s facility systematically invalidated out-of-specification testing results, claiming they were the result of "staff errors," yet providing no evidence of that.