MHRA says Akums' cannot prove progesterone made at Hardiwar plant is sterile

The facility in Hardiwar, Uttarakhand – known as Plant IV - was visited by inspectors in April in response to a request by wholesaler Nordic Pharma, which was seeking to add Akums as a supplier of the injectable fertility drug Gestone​ (progesterone injection 50mg/ml).

A Medicines and healthcare products regulatory agency (MHRA) spokesman told us "The inspection was triggered as a result of the Marketing Authorisation Holder, Nordic Pharma UK Limited, submitting a variation to change the site of manufacture to the Akum’s site​."

He added that: "Akum’s is still an ongoing case so we cannot comment further on the site’s response to the findings at this point​."

Sterility​

In the report the agency raised concerns about the sterility of progesterone made at the facility, citing Akums’ inability to prove all ampoules in a batch are sterilised as a critical deficiency.

The inspectors also said sterilisation operations are not adequately controlled and that Akums has not implemented a robust environmental monitoring programme.

The MHRA inspectors also said they had observed other deficiencies but had decided not to formally report them "so as not to distract from the critical and major deficiencies​.”

To date the Hardiwar site has supplied a small amount of unlicensed progesterone to the UK and Erie. The MHRA ordered Akums to recall the four batches shipped to date and advised doctors not to use the product.

The MHRA added that: “The variation to add Akums as a manufacturing site to the marketing authorisation has been put on hold​” and pointed out that “as this was the first inspection of the site so no manufacturing authorisation has been issued​.”

Variation​

“Variation” is the term used to describe the administrative process associated with controlling changes to an approved marketing authorisation.

A 2010 information leaflet​ for Nordic’s Gestone lists Sweden-based contract manufacturing organisation (CMO) Recipharm and UK-based SCM Pharma as suppliers.

SCM was acquired by Shire in 2014​ a few months after its sterile drug manufacturing plant in Prudhowe, UK was stipped of its manufacturing license by the MHRA.

Nordic Pharma regulatory manager Minesh Vaidya told us “Gestone was not manufactured at this [the Akums] manufacturing site​” adding that “Nordic withdrew the application to add this site to our license before this statement [on EudraGMP] was published​.”