USFDA adds one more clause to import alert on Divi's Labs

Charges firm with 'refusal for inspection', indicating possible unhygienic manufacturing processes

The US Food and Drug Administration (USFDA) has invoked one more clause in connection with the import alert issued to Unit-2 of Hyderabad-based Divi's Laboratories Limited, this time charging the company with 'refusal for inspection'.

The import alert was first issued under clause 66-40, which authorises detention without physical examination of drugs from firms that have not met drug GMPs (good manufacturing practices).

Further, the US drug regulator has added clause 99-32, which authorises similar action for products from firms refusing 'FDA foreign establishment inspection.'

While admitting the development in a disclosure to the Bombay Stock Exchange (BSE) on Wednesday, the company management, however, did not explain the reasons leading to the invocation of clause 99-32 by the US regulator.

Meanwhile, previous records show that in August 2016, 'Divi Towers', the company's headquarters in Hyderabad and an active pharmaceutical ingredients (API)-unit owned by it were placed in the import alert list under the clause 99-32.

According to the USFDA guidelines, the refusal to permit inspection of a facility or provide reasonable access to FDA's inspection personnel, combined with other evidence, gives the impression that the firm's products are manufactured, processed, or packed under unhygienic conditions.

"The company has already initiated necessary measures to address the concerns raised by the USFDA and is making all efforts to fully meet the compliance requirements," Divi's said in its latest filing .