NEW DELHI: In yet another twist to the Ranbaxy scandal, the drug regulatory authority of the UK government has issued a statement clarifying that they have found no evidence of any Ranbaxy product in the UK market having been "of unacceptable quality". Last month, WHO had issued a similar statement. It had said that there was no evidence of any of the Ranbaxy products being of unacceptable quality.
The Medicines and Healthcare products Regulatory Authority (MHRA) of UK explained that on hearing that Ranbaxy had pleaded guilty to felony charges related to drugs made at two facilities in India it had performed a number of inspections of Ranbaxy sites along with other international regulators including the USFDA and the WHO.
While some failures to comply with good manufacturing practice (GMP) were reported, the inspections did not find any Ranbaxy products in the UK market being either of unacceptable quality or putting UK patients at risk. The statement clarified: "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."
MHRA explained how it has been inspecting Ranbaxy sites since 1995 for GMP compliance and elaborated how following USFDA concerns in 2008, MHRA was part of multinational inspection teams which found that while the company complied in general with European Union (EU) GMP they needed to demonstrate continued commitment to improving standards of compliance. Continuing inspections by international teams showed that "the company had made significant progress".
According to the MHRA, India is the biggest supplier of Active Pharmaceutical Ingredients (APIs) to the EU and in the last financial year, of the 116 overseas inspections conducted by MHRA, 47 were performed in India and 52 were performed in the US. "There is not a noticeable difference in the number of significant findings identified at UK sites versus those overseas," added the MHRA. In the UK 23% of UK Marketing Authorisations name an Indian manufacturer and 38% name an Indian API source.
WHO in its statement explained that it has a number of finished pharmaceutical products (FPPs), mostly HIV/AIDS drugs, manufactured by Ranbaxy on its pre-qualified list and added that a number of generic medicines prequalified by the WHO Pre-Qualification Programme (WHO-PQP), including those of Ranbaxy, have also been approved by stringent regulatory authorities (SRAs). SRAs are those national medicines regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
The WHO-PQP statement explained: "In the USA, the term "adulterated" has a specific legal meaning. If a company is not complying with Current Good Manufacturing Practice Regulations (cGMP), any medicines that it manufactures are considered to be "adulterated" under the law. In other words, its medicines are not manufactured under conditions that comply with cGMP. It does not mean that the medicine is necessarily substandard."
Medicines Control Council (MCC) of South Africa too has assured that Ranbaxy drugs were safe and effective. MCC was part of several inspections conducted of Ranbaxy's manufacturing sites. However, the WHO as well as the MCC said that, in 2004, there were problems with Ranbaxy such as with missing data, changes to dates in documentation, and comparative data not being credible which led to many drugs being recalled from the market. But they state that it was fixed over several inspections conducted later. MCC also stated that after FDA banned products from the Paonta Sahib plant of Ranbaxy in 2006, random tests of Ranbaxy drugs on the South African market found no critical deficiencies.
According to the WHO, after USFDA issued a warning to Ranbaxy in 2008, WHO-PQP organized several inspection since the Paonta Sahib site also manufactured drugs on WHO's prequalified list. One of these inspections was conducted in November 2008 by a team of 6 inspectors — 3 from WHOPQP, one from the Therapeutic Goods Administration (TGA) of Australia, one from Health Canada and one from MHRA, UK. Some non-compliances were observed and Ranbaxy thereafter submitted documentation describing corrective and preventive actions, which were assessed by the inspection team and found acceptable. "There was no evidence to warrant any further action by WHO-PQP, or indeed by those SRAs who participated in this inspection," said WHO adding that WHO-PQP has continued to monitor Ranbaxy and all other manufacturers on the WHO list.
WHO concluded by giving a list of all the inspections it has conducted along with regulatory authorities from various countries- Swtizerland, France, Hungary, Australia, Kenya, Tanzania South Africa and the UK --since 2000 in Ranbaxy manufacturing sites in Dewas, Mohali and Paonta Sahib.
Source: Times Of India