The FDA has prohibited two Indian API manufacturers from shipping products to the US, with the agency reporting it found bare footprints in one producer’s facility and that the other had refused access for inspectors.
API refers to Active Pharmaceutical Ingredient – the key chemical compound within a drug that produces the intended therapeutic effect, essentially the active ingredient in a finished medicine.
Tyche Industries was handed a warning letter after rust-like residues on equipment and bare footprints were observed by the FDA inspectors at a site in Kakinada. Additionally, the company did not properly test any incoming raw materials used to make its API products that are shipped to the United States, reports Endpoints News.
A number of employees also admitted to providing false information to the FDA. A quality control manager and two assistant managers admitted to backdating records, and two other employees also faked temperature data for a drying oven that was supposed to be turned on during the manufacturing of a drug or substance.
The FDA inspected Tyche’s site across four days in August 2024 and the company was placed on import alerts on 2 January this year.
Meanwhile, Jagsonpal Pharmaceuticals, another drugmaker, was issued a warning letter after refusing entry to inspectors at its facility in Rajasthan, India, in March 2024. Even though the inspectors were allowed into the site five days later, they were nonetheless still given limited access to facility records and documents.
According to import records, Jagsonpal claims it is the sole manufacturer of certain products – when in fact it uses a third-party contract manufacturer. One of its drugs (or APIs) was misbranded and manufactured at an unregistered site. Jagsonpal was placed on import alerts on 17 January.
The FDA recommends both companies hire consultants to help improve the quality of their sites. The agency can withhold any new drug applications that list Jagsonpal or Tyche as the drug manufacturer.
See more from MedicalBrief archives:
EMA suspends drug approvals due to ‘unreliable’ tests in India
Counterfeit cancer drug blinds patients in Pakistan