Ahmedabad: In an unpleasant news for the country’s pharma capital Gujarat, the US drug regulator has put leading firm Intas Pharma’s Ahmedabad plant under Import Alert, which means it is barred from sending drugs to the USA.
The United State Food and Drug Administration (USFDA) inspected Intas’ Ahmedabad plant from November 22 to December 2 in 2022 and issued “11 observations” to the firm of severe lapses.
Detention without physical examination
The Import Alert for Intas published on June 1, 2023 calls for “Detention Without Physical Examination" (DWPE), which may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP). ”The kind of lapses reported by USFDA has surprised the pharma industry given that Intas Pharma generated as much as 70% of its revenues from international markets with huge presence in a whopping 80 countries, including US and Europe. As of end-2019, Instas clocked profits of $200 million.
Intas firm units
The firm has 14 manufacturing plants, 11 of which are in India and rest in the UK and Mexico. As for the lapses, a three-member team of the USFDA inspectors found glaring irregularities in the running of the plant in their 36-page Form 483. The gaps included integrity of data, which is considered to be the severest lapse, inadequate documentation practices, test methods and procedures to prevent microbiological contamination, according to official sources.
The drug inspectors were startled by the quality unit’s lack of oversight on the control and management of good manufacturing practice documents, which are critical in ensuring the drugs manufactured as safe and effective, the sources added.
They also found that the quality control department staff tore off documents related to manufacturing practices and dumped them in the quality control lab’s scrap areas. They also noticed a truck near the unit containing bags full of torn documents. Moreover, the inspectors also recovered a trash bag with documents which was hidden under a staircase in the plant.
However, the USFDA has exempted the firm’s 26 products comprising oral solid dosages and injections needed for critical care of patients. Industry sources claim the exemption might be because the US itself is facing a shortage of drugs and is at a 5-year high now.
