New Delhi: American health regulator FDA has lambasted Indian drugmaker Torrent Pharmaceuticals for allegedly disregarding standard drug manufacturing protocols and consciously releasing substandard medicines in the market.
In a strongly-worded letter, the US Food and Drug Administration accused the company of “repeating the failures and lacking control over the manufacture of drugs”.
Though the letter was sent to Torrent Pharmaceuticals last week, the FDA released it to the media Tuesday evening. The letter is a result of the FDA’s ongoing global investigations against medicines carrying cancer-causing substances that are used to treat high blood pressure.
Torrent had on 9 October informed the Bombay Stock Exchange that it has received a warning letter from the US health regulator, but added that “the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility”.
Warning letters are critical for drugmakers that export medicines to the US as failure to correct the violations listed in such letters leads to a complete import ban — leading to a fall in revenue.
In India, Torrent sells a variety of losartan drugs, including the top anti-BP drug Losar, Loram, Trilosar and Tozaar. Last month, Torrent had issued a recall of losartan products sold in the US market after some trace amounts of “unexpected impurity” was detected. But it is yet to issue a recall in India.
Several Indian drugmakers, including Lupin and Macleods Pharma, had already announced a recall of such drugs in the US.
Torrent ‘circumvented original protocol’
The FDA letter to Torrent alleged that the drugmaker did not follow its own written and approved procedures. The company was expected to follow the required quality attributes to qualify an alternate active pharmaceutical ingredient (API) — a raw material used for producing a final medicine.
The firm, FDA said, deviated from the original procedures despite knowing that the finished drugs will not be a quality product.
“You developed a new interim protocol to justify commercial use of the alternate API and circumvented original protocol, even though you had data demonstrating your process was not capable of producing quality material using the new alternate API,” the letter stated.
Medicines were released despite ‘inadequate’ results
The FDA further accused the drugmaker of “failing to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications”.
“Your response acknowledged that you did not follow your written and approved validation protocols. Your response is inadequate,” it said.
The FDA said the firm’s investigations into multiple out-of-specification (OOS) testing results — testing of finished products where results fall out of specified limits — were inadequate.
“Despite the inadequate OOS investigations, your firm disregarded initial failing OOS results and released batches based on retested results.”
For example, OOS investigation for Losartan Potassium and Hydrochlorothiazide Tablet was initiated on 4 July 2017 due to a high assay value — a metric that refers to the chemicals’ purity.
The FDA said despite confirming the high assay value, the root cause was not identified and the resulting finished product batch was distributed in the US market.
The health regulator said the error in OOS results is a repeat observation. “The FDA also cited a similar observation for inadequate investigations at your Dahej facility in Gujarat during a March 11–19, 2019, inspection.”
“Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the letter stated.
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