Drug-maker Wockhardt has appointed a United States-based consultant to help wade through quality issues at one of its Waluj plants, as pointed out by the US Food and Drug Administration.

As details of the company’s quality transgressions become public, Wockhardt sought to allay intense market speculation that the shadow cast by the FDA warning could in spread to other plants too.

In a recent letter, Wockhardt’s Murtaza Khorakiwala, said that the consultant had extensive experience and expertise in good manufacturing practice norms and they would work with the company to address issues raised by the USFDA. The consultant is reportedly Lachman Consultants, though an independent confirmation was not available from the company.

In its letter, the FDA said that Wockhardt’s products were “adulterated”, a legal term indicating that the company did not adhere to good manufacturing practices. Besides the company not conforming to manufacturing and processing norms, the letter said, products were also held in an establishment and “the owner or operator has delayed, denied, or limited an inspection, or has refused to permit entry or inspection, respectively.”

From data integrity to actually failing to provide adequate washing and toilet facilities to working areas, the FDA letter details out several quality transgressions by the company.

In fact, the regulator recommends the hiring of “a third party auditor, with experience in detecting data integrity problems, to assist you with this evaluation and to assist with your overall compliance with CGMP.”

Earlier Wockhardt had estimated that the company would take an annual Rs 550 crore hit from the US FDA warning. The company also faces trouble in the UK, as the regulatory Medicines and Healthcare products Regulatory Agency (MHRA) issued a precautionary recall for sixteen medicines made by Wockhardt at its Waluj plant.

This too followed “manufacturing deficiencies”, the MHRA had said. Wockhardt had then responded that the total one-time impact of the UK MHRA recall would be about Rs 13.5 crore.

Data integrity and other problems

Wockhardt’s FDA woes come even as the dust settles on another India-based drug maker, Ranbaxy’s decision to pay $500 million to settle fraud and criminal charges against itself in the US. Data integrity was and non-adherence to good manufacturing practices was a key transgression in Ranbaxy’s case as well.

Analysts are not yet predicting whether Wockhardt is going to be the next Ranbaxy, in terms of the long-drawn settlement of its regulatory issues. But they expect it to take at least two years, before the company is able to put a lid on this problem.

Several domestic drug-makers have had run-ins with the US FDA including Sun Pharma, Zydus, RPG and Lupin.

Wockhardt shares closed down close to 4 percent on the BSE, at Rs 638 on Thursday.

jyothi.datta@thehindu.co.in

(This article was published on July 25, 2013)
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