FDA hits Indian Drug Maker Cipla with Official Action Indicated Violations
Indian pharmaceutical giant Cipla, one of the largest pharmaceutical exporters in the world, got the equivalent of a “red card” from the Food and Drug Administration following a lab visit in August. Cipla’s lab in Goa was on the receiving end of the bad grade.
What does it mean?
The FDA gives three different “scores” that depict the results of its finding from a lab visit. The best result is a No Action Indicated, followed by Voluntary Action Indicated (VAI), which is like a “yellow card” in soccer lingo, or perhaps like a C grade on a test score.
The worst is Official Action Indicated (OAI), which means the lab had faulty or inappropriate drug-making equipment or lackluster best practices – meaning a failure to meet the FDA’s Current Good Manufacturing Practice regulations. These results can lead to regulatory actions from the FDA, including Warning Letters or outright import bans, officially known as “import alerts”.
Cipla notified the market of its OAI this month after the FDA notified them of its OAI status.
In September, following the August visit to the facility in Goa, a coastal state known as a tourist hotspot in India, Cipla investor Nomura Securities of Japan said that a cancer medication known by its trade name Abraxane was singled out by the FDA in August. Cipla produced the generic form of the drug.
Cipla is a massive drug company.
They are involved in numerous segments of the market – from over-the-counter cough suppressants and producers of the Endura Mass protein drink sold at Walmart, to HIV/AIDS medication. Cipla is also one of India’s largest producers of active pharmaceutical ingredients, or API, which are turned into pills, tablets, or injectable medication.
Cipla has been supplying drugs to the U.S. for years.
In September, the FDA approved their Abbreviated New Drug Application for Lenalidomide capsules of 5 mg, 10 mg, 15 mg, and 25 mg for sale in the U.S. The capsules are the generic version of Bristol Myers Squibb’s (Celgene) Revlimid® (Lenalidomide) capsules, indicated for patients with certain types of lymphomas.
It is not common for companies to be given an OAI. The Goa lab received two other OAI results in 2019. Since 2009, that lab has received 12 Voluntary Action Indicator results from FDA inspections, suggesting a C grade for the lab for the last ten years, as the company became a premier Indian drug maker and exporter over the period.
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