Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) has halted the sale of 16 medicines made by Wockhardt Ltd.
The move comes in the wake of the MHRA, Britain’s drug regulator, identifying manufacturing deficiencies at the Indian group’s Waluj manufacturing unit near Aurangabad, Maharashtra.
During a routine inspection in March 2013, MHRA noticed deficiencies including a low risk of cross-contamination because of poor cleaning practices and defects in a ventilation system.
The agency also found evidence of forged documents relating to staff training records that had been rewritten.
In May 2013, the Wockhardt’s Waluj plant was put on an “import alert” by the U S Food and Drug Administration (FDA).
The FDA website defines an ‘import alert’ as a ban, resulting in the detention of drugs, without physical examination, from companies that have not met so-called good manufacturing practices.
Meanwhile, speaking on the issue, Wockhardt chairman Habil Khorakiwala said, “We have been issued an alert by the MHRA. We would be shifting the manufacturing of products (from Waluj) to another facility, thereby minimizing the impact of the alert.”
The affected drugs
The sale of 16 Wockhardt medicines has been affected by the precautionary recall. These include those used for the treatment of infections, high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, dementia in Alzheimer’s patients and thyroid conditions.
However, officials at MHRA clarified that the recall was limited to retail level and as the drugs were not defective the people taking these drugs were not required to return their medicines.
“This is not a patient-level recall because, though the medicines that are affected have not been manufactured to Good Manufacturing Practice (GMP) standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK,” the regulator said.
“However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue.”