The Wall Street Journal
July 11, 2013
In another sign of possible manufacturing problems in India's pharmaceutical industry, the U.K.'s medicines regulator said it was recalling 16 drugs made by Wockhardt Ltd. after finding "manufacturing deficiencies" at one of the company's factories in India.
The Medicines and Healthcare products Regulatory Agency, or MHRA, called it a "precautionary recall," as there is no evidence that the medicines are defective. The agency said it is recalling the drugs from pharmacies and wholesalers but isn't asking patients to return their Wockhardt medicines.
"There is no evidence of a patient safety risk…. however, the MHRA has to act in the interest of public health as poor manufacturing standards cannot be allowed to continue," the agency said.
The recalled drugs, manufactured in the central Indian city of Waluj, include treatments for infections, hypertension, diabetes, epilepsy and other diseases. The MHRA said the plant suffered from "poor cleaning practices" and defective ventilation systems. The agency inspection also found evidence of "forged documents relating to staff training records."
In an emailed statement, Wockhardt confirmed the news and said the recall would result in a one-time charge of £1.5 million ($2.25 million) this year. Exports from the Waluj plant constitute less than 5% of the company's total U.K. sales and less than 2% of overall sales, it added.
It was the second recent setback for the company and its Waluj factory. In May, the U.S. Food and Drug Administration imposed an import ban on products from the factory after it failed an FDA safety inspection. The FDA didn't elaborate on the problems it found.
In a conference call at the time, Wockhardt Chairman Habil Khorakiwala said the company was implementing "corrective measures to be in compliance with the FDA guidelines." He said the U.S. import ban could cost the company $100 million in revenue this fiscal year. Wockhardt generated total revenue of 25.6 billion rupees ($460.6 million) in the year ended March 31, 2012.
Also in May, India's Ranbaxy Laboratories Ltd. agreed to pay $500 million in civil and criminal fines for exporting adulterated drugs to the U.S.
In a phone interview Thursday, D.G. Shah, secretary-general of the Indian Pharmaceutical Alliance, an industry body, said the group has written to the FDA asking it to conduct workshops with Indian companies to correct erroneous practices.
"Companies need to better understand FDA processes, and there needs to be a correction in their organizational culture, right from drug discovery to development and production," Mr. Shah said.
In another sign of possible manufacturing problems in India's pharmaceutical industry, the U.K.'s medicines regulator said it was recalling 16 drugs made by Wockhardt Ltd. after finding "manufacturing deficiencies" at one of the company's factories in India.
The Medicines and Healthcare products Regulatory Agency, or MHRA, called it a "precautionary recall," as there is no evidence that the medicines are defective. The agency said it is recalling the drugs from pharmacies and wholesalers but isn't asking patients to return their Wockhardt medicines.
"There is no evidence of a patient safety risk…. however, the MHRA has to act in the interest of public health as poor manufacturing standards cannot be allowed to continue," the agency said.
The recalled drugs, manufactured in the central Indian city of Waluj, include treatments for infections, hypertension, diabetes, epilepsy and other diseases. The MHRA said the plant suffered from "poor cleaning practices" and defective ventilation systems. The agency inspection also found evidence of "forged documents relating to staff training records."
In an emailed statement, Wockhardt confirmed the news and said the recall would result in a one-time charge of £1.5 million ($2.25 million) this year. Exports from the Waluj plant constitute less than 5% of the company's total U.K. sales and less than 2% of overall sales, it added.
It was the second recent setback for the company and its Waluj factory. In May, the U.S. Food and Drug Administration imposed an import ban on products from the factory after it failed an FDA safety inspection. The FDA didn't elaborate on the problems it found.
In a conference call at the time, Wockhardt Chairman Habil Khorakiwala said the company was implementing "corrective measures to be in compliance with the FDA guidelines." He said the U.S. import ban could cost the company $100 million in revenue this fiscal year. Wockhardt generated total revenue of 25.6 billion rupees ($460.6 million) in the year ended March 31, 2012.
Also in May, India's Ranbaxy Laboratories Ltd. agreed to pay $500 million in civil and criminal fines for exporting adulterated drugs to the U.S.
In a phone interview Thursday, D.G. Shah, secretary-general of the Indian Pharmaceutical Alliance, an industry body, said the group has written to the FDA asking it to conduct workshops with Indian companies to correct erroneous practices.
"Companies need to better understand FDA processes, and there needs to be a correction in their organizational culture, right from drug discovery to development and production," Mr. Shah said.