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 that any ofRanbaxy's products in the UK market "are or have been of unacceptable quality" . The World Health Organisation (WHO) had issued a similar statement last month that there was no evidence that any of theRanbaxy products currently included on the WHO list were of unacceptable quality.
Coming within weeks of RanbaxyBSE -1.67 %agreeing to a $500 million settlement for 'fraud' in the US, the two endorsements give the Indian pharma major a much-needed boost. Equally, they give cause for cheer to generic drug manufacturers in India and other developing countries, which were fearing being tainted by the Ranbaxy case.
The Medicines and Healthcare products Regulatory Authority (MHRA) of UK explained that on hearing that Ranbaxy had pleaded guilty to the 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.
MHRA was a member of multinational 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 Ranbaxy products on the UK market were of unacceptable quality or that UK patients were at risk, said the statement.
UK regulator says it has found no evidence of any Ranbaxy product in the UK market having been "of unacceptable quality" or putting patients at risk Last month, WHO had issued a similar statement Ranbaxy recently agreed to pay $500m to resolve allegations that it sold adulterated drugs and lied about it to US regulators
India largest supplier of API to EU
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 hasassured 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.