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Regular-article-logo Wednesday, 16 July 2025

UK heat on Wockhardt unit

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The Telegraph Online Published 12.07.13, 12:00 AM

July 11 (Agencies): The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK today said it would withdraw some medicines made by Wockhardt after it identified deficiencies in manufacturing procedures at the drug maker’s Waluj facility.

The 16 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.

The MHRA said patients did not need to return their medicines because there was no evidence that the medicines affected by the precautionary recall in the UK were defective.

“However, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue,” it said.

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 conformed to good manufacturing practice standards, there is no evidence of a patient safety risk from medicines that have been sold in the UK, the MHRA said.

“The deficiencies identified by the MHRA during a routine inspection in March included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site,” it added.

There was also evidence of forged documents relating to staff training records that had been rewritten.

The British drug regulator said it was working with Wockhardt and other regulators to resolve these issues.

Last week, Wockhardt chairman Habil Khorakiwala had said, “We have been issued an alert by the MHRA. We would be shifting the manufacturing of products (from Waluj) to another facility, thereby minimising the impact of the alert.”

Earlier in May, an import alert was also issued by the US Food and Drug Administration on the same manufacturing facility.

Khorakiwala had said that the alert by the USFDA would impact the company’s business by an estimated $100 million on an annualised basis.

Shares of Wockhardt today closed at Rs 937.95 on the Bombay Stock Exchange, down 2.40 per cent from its previous close of Rs 961.

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