Exports to EU from Ranbaxy's two plants to remain suspended
New Delhi: Exports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as probes are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said Wednesday.
The European Medicines Agency (EMA) said that Indian authorities have withdrawn certification to the Toansa plant, while an international inspection of the Dewas plant has been planned for June 2014.
"The EMA and national medicines authorities in the EU are progressing with their assessment of reports of non-compliance with Good Manufacturing Practice (GMP) at two Ranbaxy Laboratories' sites in India," a EMA spokesperson said.
Exports from Toansa and Dewas sites to the EU will remain suspended, the spokesperson said without specifying a timeline for completion of investigations.
On the Toansa plant, the official said: "On March 26, 2014, Indian authorities withdrew the site's 'Written Confirmation', effectively making the suspension of the exports official for the time being."
The Written Confirmation is a document that accompanies all APIs (active pharmaceutical ingredients) exported to the EU to certify that relevant manufacturing standards have been met.
"In the meantime, the EMA and national medicines authorities in the EU are continuing to work together to ensure that failings previously identified at the site are fully resolved before there is a resumption of exports from the site to the manufactures in the EU," it said.
Ranbaxy had voluntarily suspended exports from the sites to the EU in January 2014.
The EMA said a second unannounced international probe of the Toansa site was conducted after the USFDA banned products from the plant in January. The preliminary findings of the inspection carried out jointly by authorities from Germany, the UK, Ireland, Switzerland and Australia did not highlight any additional issues beyond those already identified.
The Toansa site had been supplying APIs for four centrally authorised medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) - and several non-centrally authorised medicines in Europe.
When contacted a Ranbaxy spokesperson declined to comment.
On the Dewas plant, EMA said an international inspection has been planned for June, 2014, till then the voluntary suspension of exports of APIs (active pharmaceutical ingredients) from the site to the EU remains in place.
Ranbaxy had announced that it was voluntarily suspending exports of APIs from its Dewas site to the EU from January.
The reason given by the company was that it needed time to conduct further internal evaluations and audits of its manufacturing processes and controls, EMA said.
"Ranbaxy has now informed authorities in the EU of findings from its internal investigation showing that there were also GMP failings at this site," it added.
An international inspection of the Dewas site is now planned for June 2014, EMA said adding that in the meantime, the voluntary suspension of exports of APIs from the site to the EU remains in place.
In view of the suspension of exports of active substances from the two Ranbaxy sites, the EMA and EU national medicines authorities are continuing to work together to limit any impact on the supply of medicines that may arise from the suspension of the exports or from any subsequent regulatory action that may be necessary, EMA said.
The Gurgaon-based firm, which has inked a merger deal worth USD 4 billion with Sun Pharma, has been at the receiving end of the USFDA for violation of manufacturing practices at its plants.
At present, all four plants of the company in India have been banned from importing drugs to the US market.
USFDA had banned imports from Ranbaxy's Toansa plant in January this month for violating current good manufacturing norms.
In September last year, the USFDA imposed an import alert on Ranbaxy's Mohali plant in Punjab for violating current good manufacturing norms.
Ranbaxy's key facilities at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh have been under a US import alert since 2008.