Drug maker Wockhardt has received some bad news and some good news about its manufacturing facility in Chikalthana, Aurangabad.
On Thursday, the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) ordered pharmacies, dispensing clinics and wholesalers to return five “prescription-only” medicines.
In a press note, the regulator said the move was dictated by a precautionary recall by the drug manufacturer, which was asking retail outlets to return five “over the counter” medicines.
Most of the medicines affected by the recall are for pain relief, besides one medicine (Gliclazide) used to treat Type 2 diabetes, the note added.
The recall was not at the patient level. The MHRA stated that people did not have to return their medicines “because there is no evidence that the medicines affected by the precautionary recall in the UK are defective. Therefore, it’s important that people continue to take their medicines as prescribed.”
Simultaneously, the UK regulator also allowed Wockhardt to make 10 prescription medicines at its Chikalthana site and supply them to patients in the UK.
The MHRA says it took this action as it was concerned over the continuity of supply, and that the benefits to patients continuing on these medicines outweigh the risk from any quality concerns.
Revenue Impact
Meanwhile, in a note to the Bombay Stock Exchange, Wockhardt said the recalled products would have a one-time impact of £1 million (about Rs 10 crore). The approximate revenue from the products it was allowed to make was about £3 million (about Rs 30 crore), it added.
The Chikalthana plant is already facing regulatory action from the US FDA. It is the second Wockhardt unit under the scanner of the foreign US and the UK regulators, the first being its unit in Waluj (near Aurangabad).
The recall order follows an MHRA inspection of the Chikalthana site, which identified manufacturing deficiencies.
The MHRA note added that the recall was not at the patient level, as there was no evidence that patients were at risk from these medicines, though they had not been manufactured under the Good Manufacturing Practice standards. But the regulator said it had to act “as poor manufacturing standards means that the quality of medicines is not guaranteed.”
The manufacturing deficiencies identified by the MHRA during inspection of the Chikalthana site in July included poor record-keeping relating to the manufacture and testing of medicines and inadequate validation and production controls for medicines. The MHRA is working with Wockhardt and other international regulators to resolve this.