EMA statement on oversight of Ranbaxy Laboratories plants in India

EMA statement on oversight of Ranbaxy Laboratories plants in India

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. Exports of active pharmaceutical ingredients (APIs) to the EU have now been suspended. The two manufacturing sites currently being assessed are Ranbaxy's Toansa site in Punjab and the Dewas site in Madhya Pradesh.

·         Update on the Toansa site:

-         Following a recent FDA inspection which revealed areas of non-compliance with Good Manufacturing Practices (GMP),[1] a second unannounced international inspection of the Toansa site has been conducted. 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.

-         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. The company had voluntarily suspended exports from the site to the EU in January 2014.

-         Authorities in the EU have been in contact with Indian authorities. On 26th March 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 exported to the EU to certify that relevant manufacturing standards have been met.

-         The Toansa site had been supplying APIs for 4 centrally authorised medicines – Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide), and Nevirapine Teva (nevirapine) – and several non-centrally authorised medicines.

·         Update on the Dewas site:

-         In January 2014, Ranbaxy also announced that it was voluntarily suspending exports of APIs from its Dewas site. The reason given by the company was that it needed time to conduct further internal evaluations and audits of its manufacturing processes and controls.

-         Ranbaxy has now informed authorities in the EU of findings from its internal investigation showing that there were also GMP failings at this site.

-         However, data presented by Ranbaxy indicate that there is no impact on the quality or safety of products on the EU market. Further information from Ranbaxy however is required for EU authorities to complete the assessment.

-         An international inspection of the Dewas site is now planned for June 2014. In the meantime, the voluntary suspension of exports of APIs from the site to the EU remains in place.

-         The Dewas site was not a supplier of APIs for any centrally authorised medicine.

·         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.

·         While the assessments in the EU are ongoing, EU Member States may decide to take temporary precautionary measures in their territories. It should be noted, however, that there is at present no evidence suggesting that products currently on the EU market pose a risk to public health. EU and national authorities will take necessary action to protect the health of EU patients should any risk be identified.

·         Patients are advised that there is no reason for them to stop taking their medicines. If they have any questions or concerns they should speak to their doctor or pharmacist.