UK drug regulator bans 16 medicines made in India

UK drug regulator bans 16 medicines made in India UK drug regulator Medicines & Healthcare Products Regulatory Agency (MHRA) has banned the sale of 16 medicines manufactured by Wockhardt Ltd's Waluj factory in India.

The MHRA ordered the ban after it identified several manufacturing deficiencies at the drug maker's Waluj, Maharashtra-based manufacturing plant during a routine inspection conducted in March. The list of identified manufacturing deficiencies included cross-contamination and data falsification.

While directing pharmacies, dispensing clinics and wholesalers to immediately stop selling the drugs, the regulator also said that it found no evidence of any defect in the medicines and therefore patients who already have purchased the medicines didn't need to return them.

Ordering the ban, the regulator said, "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."

It underlined that it was not a patient-level recall, and that the step was taken in the interests of public health as poor manufacturing standards couldn't be allowed to continue.

Wockhardt's exports out of the Waluj facility accounts for the company's less than 5 per cent of total sales in the UK, but the one-off impact of the recall would be as high as 1.5 million pounds.