UK regulator recalls 16 Wockhardt medicines

NEW DELHI: UK drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday said it would recall certain medicines from pharmacies and clinics in the UK made by Wockhardt after it found deficiencies in manufacturing procedures at Wockhardt's Waluj plant.

In May, the US Food and Drug Administration had imposed an "import alert" on Wockhardt's Waluj plant.

"This follows manufacturing deficiencies identified by the MHRA at Wockhardt's Waluj site in India," MHRA said in a statement.

The sixteen 'prescription only medicines' 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 added.

Earlier, Wockhardt had said that the FDA's action potentially affected around $100 million in revenue on an annualised basis. An "import alert", effectively a ban, results in the detention of drugs, without physical examination, from companies that have not met good manufacturing practices, according to the FDA website.

The MHRA said that the deficiencies found in Wockhardt's medicines were identified during a routine inspection in March. It found a low risk of cross-contamination because of poor cleaning practices and defects in a ventilation system.

The Waluj facility makes injectables and solid dosages. MHRA's Director of Inspection Enforcement and Standards Gerald Heddell said: "This is a precautionary recall. People can be reassured that there is no evidence that medicines made by Wockhardt are defective so it's important people continue to take their medicines as prescribed."

This is not a patient level recall because although 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, MHRA said.

There was also evidence of forged documents relating to staff training records that had been rewritten, MHRA said. The UK drug regulator said it is working with Wockhardt and other international regulators to resolve these issues.

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