MHRA press statement on Ranbaxy : MHRA

MHRA press statement on Ranbaxy : MHRA : \'

Statement on Ranbaxy following from the US justice department announcing that Ranbaxy USA Inc. a subsidiary of Ranbaxy Laboratories limited had pleaded guilty to felony charges relating to the manufacture and distribution of adulterated drugs made at two facilities in India.

An MHRA spokesperson said:

“We have no evidence that any of the products on the UK market manufactured by Ranbaxy are or have been of unacceptable quality. There is also no evidence that patients in the UK have been put at risk. Patients should continue to take their medicines as prescribed by their healthcare professional.

“In investigating the concerns raised with the quality of Ranbaxy products we, in conjunction with other regulators, conducted a review of the allegations which included undertaking on-site inspections in India and sampling and testing of Ranbaxy products from the UK market.

Routine inspections of Ranbaxy manufacturing sites that supply medicines to the European Union (EU) continue to be carried out by inspectors from European countries and samples tested have been satisfactory.

“In light of the recent declaration made by Ranbaxy, we are consulting with other EU and international regulators including the FDA to review whether any further action is deemed appropriate.”

Q&A

How can you be sure that the products on the UK market are safe?

The MHRA responded quickly when information first came to its attention. The Agency worked with other international regulators including the US Food and Drug Administration (FDA) and the World Health Organisation (WHO) to investigate the various issues. A number of inspections were performed of Ranbaxy sites and the MHRA was a member of various multi-national inspection teams. Whilst some failures to comply with Good Manufacturing Practice (GMP) were reported the findings made during these inspections did not indicate that any of the products on the UK market manufactured by Ranbaxy were of unacceptable quality or that there was a risk to patients in the UK. As part of their investigations the MHRA has tested samples of Ranbaxy products taken from the UK market. All samples met the correct quality specifications.

What action if any has the MHRA taken?

• The MHRA has been inspecting Ranbaxy sites in India since 1995 and has a large amount of data concerning Good Manufacturing Practice (GMP) compliance. These data and information from other regulators were used to inform the format of an inspection of the Ranbaxy site at Paonta Sahib in October 2006 by two inspectors from the MHRA. The inspection included matters relating to the allegations of malpractice that had been reported to the MHRA and other regulators. The findings of this inspection and the company’s responses led the inspectors to conclude that the company complied in general with EU GMP, but they added that the company needed to demonstrate a continuing commitment to improving standards of compliance. Support was given for issue of a GMP certificate.

• Findings from the inspection conducted in October 2008 by inspectors from the MHRA, Australia and Ireland were referred to the MHRA\'s multi-disciplinary Inspection Action Group for discussion. The inspection was subsequently closed on receipt of satisfactory responses from the company and a GMP certificate was issued with the recommendation that an early re-inspection be conducted.

• In 2008 the MHRA was part of another multinational inspection team that investigated the issues raised by the FDA. Currently other EU Member States have direct GMP responsibility for these sites.

• Inspections in November 2009, in which the MHRA inspector was accompanied by a WHO inspector and February 2010, in which the MHRA inspector was accompanied by an inspector from Ireland, demonstrated that the company had made significant progress.

• A Good Clinical Practice (GCP) inspection of one of the Ranbaxy sites in India was conducted in February 2009, This concentrated on bioequivalence activities. Some non-compliances with GCP were observed but these did not indicate a significant risk to patients. This site will be scheduled for a re-inspection in relation to their bioequivalence activities according to the current risk based inspection model and is likely to be scheduled within the next 12 months

• In 2010, Ranbaxy UK carried out a precautionary medicine recall at wholesale and pharmacy level. This followed concerns over regulatory compliance issues identified during pharmacovigilance inspections by the MHRA and the Irish Medicines Board (IMB). These compliance issues resulted in the failure by Ranbaxy UK to update some Patient Information Leaflets (PILs) following approval by the MHRA of safety-related variations.

• An analytical survey involving 50 samples of Ranbaxy products was conducted by the MHRA Laboratory in 2008 and pre-approval projects were run on three Ranbaxy products for which licences were applied. All results were satisfactory.

How dependent is the UK on India to supply medicines?

India produces 10% of the world’s medicines. In the UK 23% of UK Marketing Authorisations name an Indian Manufacturer and 38% name an Indian Active Pharmaceutical Ingredient source. India is the biggest supplier of active pharmaceutical ingredients to the EU.

Inspections performed by the MHRA are scheduled according to a risk based model and there are various triggers for inspections to be performed including whistle-blowers and information received from another regulator. Last financial year the MHRA performed around 400 inspections in the UK and 116 overseas. Of the overseas ones 47 were performed in India, and for note 52 were performed in the USA.

There is not a noticeable difference in the number of significant findings identified at UK sites vs. those overseas.