USFDA rebukes Torrent Pharma management of inadequacy, violations at multiple sites

Repeated failures at multiple sites of Torrent Pharma demonstrate that executive management oversight and control over the manufacture of drugs is inadequate, states the USFDA warning letter.

New Delhi: The US health regulator has pulled up the Cheif of Torrent Pharmaceutical Ltd for violations across multiple facilities, wherein, the Gujarat-based pharma firm allegedly disregarded standard drug manufacturing protocols and consciously released substandard drugs in the market.

"Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," USFDA stated in the warning letter.

The US Food and Drug Administration (USFDA) issued a warning letter to Torrent Pharma summarizing significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act," reads the USFDA letter.

During the USFDA inspection, the investigators observed specific violations and deviations including, but not limited to, the following;

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  The firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.

  
  

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  The firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

  
  

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USFDA held the firm's executive management responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. It further directed the firm to immediately and comprehensively assess the company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.

Coming down heavily, USFDA went on stating that the use of a consultant does not relieve the drugmaker's obligation to comply with CGMP. The firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

The regulator further warned Torrent Pharma that until all violations are rectified completely and USFDA confirm the company's compliance with CGMP, the regulator may withhold approval of any new drug applications or supplements listing the firm as a drug manufacturer.

"Failure to correct these violations may also result in the FDA refusing admission of articles manufactured at Torrent Pharmaceuticals Limited, Ahmedabad-Mehsana Highway, Taluka-Kadi, Indarad, Gujarat, into the United States," the regulator added.

Also read: Torrent Pharma Indrad facility gets USFDA warning letter