Tags:
Journalism of Courage
Share prices of Aurobindo Pharmaceuticals took a hit Monday, dropping nearly 20 per cent after quality and data issues flagged by the US food and drug regulator on the company’s Polepally plant in Telangana came to light. Meanwhile, the firm told bourses that none of the observations are related to data integrity.
The US Food and Drug Administration (FDA), on September 27, issued seven observations to the drug maker in a Form 483 following an inspection of the site. The Indian Express has viewed a copy of the observations. An FDA Form 483 is issued to companies upon completion of an inspection when investigators observe conditions deemed to violate US drug regulations.
Among the observations to Aurobindo, the FDA said the company’s laboratory records “do not include complete data derived from all tests, examinations and assay necessary to ensure compliance with established specifications and standards”. The FDA’s review of electronic audit trails related to one of the automated machines involved in the company’s production and testing process showed several instances of the process being interrupted.
It said the firm’s quality unit “did not periodically review these audit trails and assess what may have causes these events” and that the company “also failed to investigate what those interruptions are and why the analysts may have stopped during a run”.
The regulator also said that Aurobindo failed to “thoroughly review” any unexplained discrepancy and failure of batches of the medicines manufactured at the plant. “Specifically, your firm’s investigations were found to be deficient in that the Out of Specification (OOS) results have been invalidated for various tests without identifying scientifically sound and justifiable root causes,” it stated in the form.
Another observation was that the firm did not clean equipment and utensils “at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.” The regulator further observed that the responsibilities and procedures applicable to the quality control unit were not fully followed.
“Several lists of documents requested were either provided as incomplete, inaccurate, and/or explained with potentially misleading statements throughout the inspection,” said the FDA.
Share prices of Aurobindo on the BSE closed at Rs 458.50 apiece – falling 19.16 per cent from Rs 567.15 per share on October 4.
Queries sent to Aurobindo remained unanswered by press time Monday. However, the company confirmed to BSE in a clarification that FDA had conducted a cGMP inspection at its Unit 7 manufacturing facility from September 19-27. “The inspection ended with seven observations. We believe none of the observations are related to data integrity. The company is confident of addressing these issues within the stipulated timeline,” it said.
Meanwhile, share prices of Glenmark Pharmaceuticals also dropped 9.30 per cent on Monday to close at Rs 286.30 per share, following its announcement Saturday that the FDA had issued a warning letter for its facility in Baddi, Himachal Pradesh.
“The company is committed to work along with the USFDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the USFDA within 15 working days,” stated Glenmark in a filing.
