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Drug maker Wockhardt Ltd, which received an import alert from the UK drug regulator last week ceasing supplies, has been told to recall existing stocks from the British market. This includes 16 prescription products of various strengths. However, the recall is limited to the retail level and the regulator has advised patients to continue with their medicines as prescribed.
The move comes in the wake of the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK drug regulator, identifying manufacturing deficiencies, including a risk of cross-contamination and evidence of data falsification, at Wockhardt’s Waluj manufacturing facility near Aurangabad, Maharashtra, during a routine inspection in March.
“Pharmacies, dispensing clinics and wholesalers were today asked to return 16 different prescription only medicines in a variety of strengths made by Wockhardt following a precautionary recall by the MHRA,” the regulator said in a press statement. The medicines affected by the precautionary recall 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, it said.
However, the agency clarified that patients were not required to return their medicines because there was no evidence that the drugs affected by the precautionary recall in the UK were defective.
“This is not a patient level recall because although the medicines that are affected have not been manufactured to good manufacturing practice standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue,” the regulator said.
According to a Wockhardt spokesperson, the company is estimated to take a one-time hit of around £1.5 million ( around Rs 13.5 crore) due to the recall. “The exports out of the Waluj plant constitute less than five per cent of the total UK sales and less than two per cent of the overall sales of Wockhardt,” it said.
The MHRA is currently working with Wockhardt and other international regulators to resolve the issues highlighted by the regulator.
In May, the Mumbai-headquartered drug maker had received an import alert from the US Food and Drug Administration for the same facility, projecting an impact of around $100 million during the current financial year. The company is yet to restore supplies to the US from the unit.
On Thursday, shares of Wockhardt ended at Rs 937.95 on BSE, down 2.4 per cent, when the benchmark Sensex gained 1.98 per cent to 19,676.06.
The move comes in the wake of the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK drug regulator, identifying manufacturing deficiencies, including a risk of cross-contamination and evidence of data falsification, at Wockhardt’s Waluj manufacturing facility near Aurangabad, Maharashtra, during a routine inspection in March.
“Pharmacies, dispensing clinics and wholesalers were today asked to return 16 different prescription only medicines in a variety of strengths made by Wockhardt following a precautionary recall by the MHRA,” the regulator said in a press statement. The medicines affected by the precautionary recall 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, it said.
However, the agency clarified that patients were not required to return their medicines because there was no evidence that the drugs affected by the precautionary recall in the UK were defective.
“This is not a patient level recall because although the medicines that are affected have not been manufactured to good manufacturing practice standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK. However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue,” the regulator said.
According to a Wockhardt spokesperson, the company is estimated to take a one-time hit of around £1.5 million ( around Rs 13.5 crore) due to the recall. “The exports out of the Waluj plant constitute less than five per cent of the total UK sales and less than two per cent of the overall sales of Wockhardt,” it said.
The MHRA is currently working with Wockhardt and other international regulators to resolve the issues highlighted by the regulator.
In May, the Mumbai-headquartered drug maker had received an import alert from the US Food and Drug Administration for the same facility, projecting an impact of around $100 million during the current financial year. The company is yet to restore supplies to the US from the unit.
On Thursday, shares of Wockhardt ended at Rs 937.95 on BSE, down 2.4 per cent, when the benchmark Sensex gained 1.98 per cent to 19,676.06.
