MHRA orders recall of Wockhardt drugs after import ban
pharmafile | July 11, 2013 | News story | Manufacturing and Production | MHRA, Wockhardt, recall
The UK regulatory authority has asked for a recall of medicines made at a Wockhardt facility in India, shortly after joining the US in imposing an import ban on drugs made there.
Following an inspection, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement of non-compliance with Good Manufacturing Practice (GMP) for Wockhardt’s Waluj manufacturing facility in Aurangabad, sparking a fall-off in the Indian drugmaker’s shares.
Now, the agency said that 15 medicines made at Waluj are subject to a precautionary recall at the wholesale and pharmacy level, including antibiotics and drugs for high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, Alzheimer’s dementia and thyroid disorders.
Products already in patients’ hands are unaffected and do not need to be returned, said the agency, saying there is “no evidence of a patient safety risk from medicines that have been sold in the UK”.
The MHRA’s block on the supply of drugs made at the plant that applies not only in the UK but across the entire EU, according to Bloomberg. The action relates to a unit at the plant which makes oral solid dosage forms such as tablets, capsules and dry syrups.
Production at the plant has been temporarily suspended and Wockhardt has said it should be able to maintain supplies of the affected products from other GMP-certified sites. It only expects the shutdown to last around three months. The drugmaker said previously it would take a charge of around $100 million as a result of the US import alert, but has not commented on the impact of the UK action.
Wockhardt has been growing at breakneck speed in the last few years, with sales topping the $1 billion mark for the first time in the last fiscal year, but analysts said the problems at Waluj could lead to a 15%-20% dip in revenues this year. For its part, the company said it expected sales growth to be flat; last year, revenues advanced 29 per cent.
The Waluj facility failed a US inspection earlier this year and was issued with a Form 483 citing a number of deficiencies in April in production areas handling injectable products. It was also taken to task by the FDA in 2006 and issued a warning letter over poor record-keeping.
The deficiencies identified by the MHRA included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten.
“The MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue,” said the agency in a statement released today (11 July).
Meanwhile, the Indian government has placed a ban on the sales of an opioid analgesic sold by Wockhardt and other drugmakers in a bid to clamp down on its misuse by drug addicts. The drug – called dextropropoxyphene, is sold by Wockhardt as Proxyvon and accounts for around 4% of the company’s domestic turnover, according to local news reports.
Phil Taylor
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