According to a report constructed by the US Food and Drug Administration (FDA), Indian pharmaceutical company Wockhardt concealed the results of failed tests and discarded data at its manufacturing facility in Western India. The letter was sent to the drugmaker in early January of this year.
The FDA has been cracking down on pharmaceutical manufacturers in India – including Sun Pharmaceutical, Dr. Reddy’s Laboratories and Cadila – since last year in an effort to improve quality standards there. In particular, the agency has focused on identifying issues surrounding data integrity, including the maintenance of accurate records.
India’s pharmaceuticals industry is worth an estimated $15 billion, and the country is one of the largest manufacturing centers for generic medications in the world. Wockhardt makes approximately $134 million – one fifth of its $670 million in annual revenues – from the US market. The Shendra facility – the subject of the FDA’s letter – manufactures injectable drugs that are a key piece of Wockhardt’s business in the US.
According to the letter sent to the Indian drugmaker on January 12, multiple data files were deleted from select machines. In addition, the audit found that the results of 22 tests with failing results were not recorded.
The FDA failed to specify which drug products could be impacted by the issues with data integrity at the Shendra plant. The agency did not comment on whether the violations would have any effect on the quality of the drugs produced there, which are also exported to the UK.
The agency also identified poor labeling and storage practices for pharmaceutical ingredients. The audit found that some batches were not labeled with expiry dates, and a failed batch of pharmaceuticals was being stored in an “approved material” section of the facility.
Until Wockhardt submits a detailed report to the FDA outlining how they plan to correct the issues, the company is prohibited from exporting any products from the facility to the US. While investors were made aware of the FDA’s letter last month, Habil Khorakiwala – Chairman of Wockhardt – commented that he did not think the FDA’s findings included issues with data integrity. Khorakiwala said he expects the issues to be corrected within the next two months.