FDA Takes Action Against Cancer Drug Maker Intas: Warning Letter Issued

The US Food and Drug Administration (FDA) has raised serious concerns about the quality control practices at Intas Pharmaceuticals’ plant in Sanand, India, going so far as to send a warning letter citing “significant violations” of regulations. Moreover, it was discovered that certain data had been destroyed and discarded at the facility.

In November 2022, disturbing reports emerged that a quality control officer had observed an Intas analyst emptying acetic acid into a trash bin containing CGMP records, as well as destroying data sheets and titration curves. Though the employee alerted company management, an investigation was only launched by Intas a week later, according to the FDA’s letter.

An Intas analyst revealed to FDA investigators that, after weighing out amitriptyline hydrochloride tablets, he had failed to report some results, and had even gone so far as to throw away balance printouts.

Across Intas’ manufacturing facilities, investigators from the FDA discovered plastic bags bulging with discarded CGMP documents. This discovery suggested that the company had thrown away critical papers such as Environmental Monitoring Systems engineering checklists, analytical test reports, titration curves, and balance weights slips related to the production of their drugs.

The FDA issued a 36-page document in December 2022 detailing issues with Intas’ data governance protocols and issued a warning letter last Friday reiterating their concerns. Intas had previously promised to address the issues, but had not yet met the FDA’s requirements.

The FDA has harshly criticized the inadequate response to a deficiency, noting that it did not adequately evaluate the scope of the deficiency and its impact on product quality. What’s more, the letter also noted that lab, operations, and quality assurance management had failed to provide proper oversight over documentation and prevent data integrity lapses. This points to a significant deficiency that must be addressed.

The United States Food and Drug Administration (FDA) has imposed an Import Alert on Intas Pharmaceuticals due to repeated violations of Current Good Manufacturing Practices (CGMPs). The alert is in place of physical examination for certain cancer drugs, such as carboplatin and cisplatin, which are in desperate shortage in the United States. This alert could potentially hamper medical practices and further deepen the scarcity of these crucial drugs in the US.

The recent shortage of two drugs has been linked to the closure of Intas Pharmaceuticals’ Gujarat facility, according to American Society of Health-System Pharmacists’ Erin Fox. In a recent interview, Fox revealed that Intas had been responsible for roughly half of the supply of the drugs, suggesting that its closure could have had a significant impact on the availability of these pharmaceutical products.

The FDA has had to take drastic measures to secure scarce medicines such as cisplatin, importing them in May from Qilu Pharmaceuticals in China as a temporary solution. Ultimately, policy incentives need to be put in place to ensure the domestic production of these essential medicines.

In a move to prevent a recurrence of drug shortages, House Republicans have proposed a draft bill to tackle the issue head-on. One of the bill’s key initiatives encourages the acceleration of domestic manufacturing, launching a pilot program for licensing the production of these facilities. It’s a bold move to ensure vital medications are available and accessible for all.

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