Moneycontrol Bureau
Shares of Wockhardt slipped 4 percent intraday on Wednesday as it has been failing to meet health regulators' standards. In a latest, the US Federal Drug Administration (US FDA) has said that management of the drug major company has deleted key trial data from hard drives, reports CNBC-TV18. It raises concerns about integrity of data the company has generated.
The warning letter indicated that the deficiencies were deep rooted and said the data generated by Wockhardt's plants lacked reliability and accuracy. It also said that the Wockhardt management has not been adept in addressing the issues pointed out earlier.
The US FDA has said that it is concerned about Wockhardt's responses to the health regulator's queries and lab records are not in compliance with established standards. It also added that company did not take appropriate actions to resolve defects while actual samples were used as 'trial' injections.
The US drug regulator in its harshly worded warning letter has indicated that the data integrity issues at Wockhardt are not restricted just to its Waluj and Chikalthana plants. Reason why, the generic drug manufacturer has been asked by US FDA to conduct a global assessment of its plants to ensure that the drug produced by the company conform to FDA requirements for safety, efficacy, and quality.
Questioning the reliability and accuracy of tests conducted by Wockhardt, the FDA in a letter expressed concerned about its inability to implement a robust and sustainable quality system.
The company has been facing health regulator's hurdles. US FDA had imposed restrictions on import of medicines produced at the company's Chikalthana and Waluj plant at Aurangabad in Maharashtra. Earlier, even the US drug regulator issued an import alert on Wockhardt’s Waluj facility and its unit in Kadaiya in Nani Daman for violation of norms.
The US FDA has asked the Indian drug-maker to appoint a third party auditor to help assess data integrity issues. But analysts say looking at the enormity of the deviations, it would take a long time for Wockhardt to resolve these issues and start supplies from these plants to the US market. With US FDA indicating that the manufacturing deficiencies could be at all of Wockhardt’s plants, this also diminishes the company’s ability to transfer production of its key drugs to other plants.
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