Ranbaxy hires consultants as part of consent decree with USFDA

Ranbaxy hires consultants as part of consent decree with USFDA

May 29th, 2012 // 12:35 pm @

Drug major Ranbaxy Laboratories today said it has hired two US-based consultants to advise it on remedial work to be done at its manufacturing units in India as part of a consent decree signed with the USFDA to revoke ban imposed by the US health regulator.

The company said it expects the consultation process to be completed before the quarter ending June this year, following which it can get ahead with the residual work.

“We have engaged two consultants from US. These consultants will come and visit our plants. After they have seen, they will tell us if there is and what is the residual work that we need to do…” Ranbaxy CEO & Managing Director Arun Sawhney told PTI.

Asked how long the process will take, he said: “..all of this is going to happen before quarter ending June.”

On the overall time that is expected to take for the ban to be lifted, Sawhney said: “The time is governed by certain steps we will have to take in the consent decree. One of the things to estimate how early we can get back into business is to make an assessment of how long will it take us to do some of those measures.”

The company had signed a consent decree with the US Food and Drug Administration (USFDA) in December last year, which was then filed with the US District Court of Maryland in January this year.

Under the decree, the company had committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices in order to lift ban imposed on its plants in India by the USFDA.

Ranbaxy’s facilities at Paonta Sahib and Batamandi (both in Himachal Pradesh) along with Dewas (in Madhya Pradesh) have been on FDA import alert since 2008.

The USFDA had banned 30 generic drugs produced by Ranbaxy at these three units, citing gross violation of approved manufacturing norms.

Ranbaxy had also closed its Gloversville facility in New York in July last year.

According to the USFDA, the consent decree also prevents Ranbaxy from manufacturing drugs for introduction to the US market and for the President’s Emergency Plan for AIDS Relief (PEPFAR) Programme at the Paonta Sahib, Batamandi, Dewas and Gloversville facilities until drugs can be manufactured at such facilities in compliance with US manufacturing quality standards.

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