PEPFAR drops Ranbaxy from recommended list

By Gareth Macdonald

- Last updated on GMT

Related tags: Good manufacturing practice, Pharmacology, Pharmaceutical drug

Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.

The three drugs are produced at the facilities in Dewas and Paonta Sahib, India that are currently the subject of a US Food and Drug Administration (FDA) import ban. Earlier this year, An agency inspection identified significant deviations from good manufacturing practice (GMP) standards.

A spokeswoman for the US President’s Emergency Plan for AIDS relief (PEPFAR) told in-PharmaTechnologist.com that although the FDA’s import ruling applies only to the US, PEPFAR policy is to only buy “drugs that meet standards equal to those established [in the country]​”.

In 2007, PEPFAR supported the procurement of around $9m (€6m) of HIV drugs from Ranbaxy, The PEPFAR spokesperson explained that local implementing partners are now being notified that programme funds may only be used to buy antiretrovirals made by alternative manufacturers.

Fellow Indian generics makers Aurobindo Pharma and Cipla are among those most likely to provide alternate supplies as both companies have already been cleared by PEPFAR’s $1.9bn a year programme.

To date, the FDA has found no evidence that Ranbaxy has shipped defective or unsafe products and has not issued a recall of existing stocks. Indeed, when the agency announced its decision early last week it said it was “purely a preventative measure​”.

The PEPFAR spokeswoman also said that, on this basis, the group is not recommending “that governments or implementing partners withdraw existing drug stocks produced by or containing active ingredients produced by Ranbaxy at the two affected plants at this time.”

In response, a Ranbaxy spokesperson told in-PharmaTechnologist.com that the company "is confident that all its pharmaceutical products are safe and effective, including the HIV/AIDs drugs it supplies to Africa through various aid programmes, including PEPFAR.”

He added that: “Ranbaxy is committed to working with chairman Dingell and FDA to put these matters to rest and continue and expand its important place in providing safe and affordable medications to U.S. and global citizens​."

Daiichi acquisition awaits Indian clearance

Despite Ranbaxy’s current difficulties with US authorities, Daiichi Sankyo’s acquisition plans are still on track. The Japanese pharmaceutical firm, the country’s second largest by sales, completed its tender offer last week and is awaiting clearance from India’s Cabinet Committee on Economic Affairs to execute the transaction.

Ranbaxy shareholders accepted Daiichi’s offer to buy more than the 92.5 million shares on the open market for $1.5 billion, according to a statement last week by ICICI Securities, the brokerage which is overseeing the deal.

Related topics: Regulatory & Safety

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