he Wockhardt factories located at Waluj and Chikalthana in Aurangabad district of Maharashtra had halted exports to the US, a market that contributed at least 30% of its revenue in fiscal 2011 and 2012. Photo: Bloomberg
Mumbai: The US drug regulator has accused Wockhardt Ltd of manipulating data related to production trials of drugs at its two Indian factories, which had earlier been banned from shipping medicines to the US.
The Wockhardt factories located at Waluj and Chikalthana in Aurangabad district of Maharashtra had halted exports to the US, a market that contributed at least 30% of its revenue in fiscal 2011 and 2012.
“The lack of reliability and accuracy of data generated by your firm’s laboratory is a serious manufacturing standard (cGMP) deficiency that raises concerns about the integrity of all data generated by your firm,” the FDA wrote to Wockhardt chairman Habil Khorakiwala in a 25 November letter.
A copy of the letter, which was posted on the FDA’s website on 3 December, also says, “Your firm failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards and we (the FDA) are also concerned that your quality unit allowed the practices of ‘trial’ injections and deletion of HPLC files to persist without implementation of sufficient controls to prevent data manipulation.”
Data integrity issues at drug factories attract severe penal action from the regulator as well as government agencies. Many drug companies, including India’s Ranbaxy Laboratories Ltd, which had faced similar charges, paid penalties to settle the problems.
Such companies may also have to sign consent decrees to resolve the shortcomings with much longer resolution time and thereby revenue loss for several years.
The FDA letter added that its investigators observed the company’s practice of performing “trial” injections for HPLC (quality measuring parameters) analyses, used to test content uniformity, assay and dissolution for release and stability of different products.
“Our investigator discovered that some of the ‘trial’ injection data was not kept on the HPLC hard drives because your firm deleted it, which was confirmed by the company’s management,” FDA said.
Wockhardt’s management had confirmed to the FDA investigators during the inspection of the facility that the files were deleted as part of an internal audit conducted as a result of the March 2013 FDA inspection at its facility located in Waluj, the FDA letter said.
“It’s often the floor managers who are responsible for the shortcomings at these factories and the senior management are mostly unaware of the facts,” said a former US FDA official who is currently advising troubled drugmakers in India.
Wockhardt had fired several floor managers, who were found guilty, Minthad reported in October.
The company’s Waluj factory received the first import alert in May.
On 27 November, the second factory at Chikalthana was also banned by the US drug regulator, affecting the sale of all but five drugs in the US market.
The company’s US market sales had fallen by 26% to $87 million in the September quarter from a year earlier, mainly due to the Waluj ban. The Chikalthana unit contributed about $40 million or 46% of US sales in the September quarter.
On Wednesday, Wockhardt shares fell 3.82% to Rs.403.15 on the BSE while the exchange’s benchmark Sensex shed 0.7% to 20,708.71 points. In the past three months, Wockhardt shares fell 8.66% while the Sensex rose 11.53%.
Immediately after banning Wockhardt’s Waluj factory from exporting products to the US in August, the FDA wrote to Khorakiwala detailing malpractices at the company’s plant in Waluj that go beyond issues related to compliance with manufacturing standards.
The FDA letter, a copy of which was reviewed by Mint, said the company had not only violated standards of manufacturing practices but also misguided the regulator. Wockhardt personnel allegedly blocked an inspection of the facility by FDA officials. It stands charged with violation of the Code of Federal Regulations.
“On 18 March, an FDA investigator identified the presence of torn raw data records in the waste area and asked one of your firm’s quality assurance officers to remove these torn raw data records for the investigator’s review. This officer presented the FDA investigator with approximately 20 paper records, none of which included raw data entries identified in the waste area earlier during the inspection,” said the letter to Khorakiwala.