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Drug-maker Ranbaxy can take some comfort from a recent World Health Organisation (WHO) observation on its products featuring in the WHO list of prequalified medicines.
“At present, there is no evidence that any of the Ranbaxy products currently included on the WHO List of Prequalified Medicinal Products is of unacceptable quality,” the WHO said.
Ranbaxy is in the eye of a storm after it agreed to a $500 million settlement of fraud and criminal charges against it in the U.S. The company had pleaded guilty to felony charges relating to the manufacture and distribution of adulterated drugs made at its two facilities in India.
Legal meaning
The WHO note points out that “adulterated” has a specific legal meaning in the U.S. “If a company is not complying with Current Good Manufacturing Practice (cGMP) Regulations, 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 sub-standard.”
The entire saga of falsified data dates back to the WHO dropping Ranbaxy from its pre-qualification list in 2004. This, along with similar practices identified in later investigations by the U.S. Food and Drug Administration (USFDA), led to the May 2013 legal action.
The WHO’s Pre-qualification of Medicines Programme (PQP) acts as a booster for companies featuring on the list. Governments of various countries take their cue from this list for their own public-health programmes, and this sometimes translates into sourcing agreements as well.
In 2004, three anti-AIDS products manufactured by Ranbaxy and two products manufactured by Cipla were removed from the WHO pre-qualified list. “The removal came after WHO-PQP reported deficiencies during inspections of a number of contract research organisations, including Vimta Labs, based in India, that had conducted bioequivalence (BE) studies for pharmaceutical companies,” the WHO said.
Subsequently, many companies seeking pre-qualification of their products reviewed their submissions. Ranbaxy voluntarily withdrew seven products in November 2004.
A bio-equivalence study establishes that a generically similar drug is as effective as the original version. Companies, including Ranbaxy, conducted new tests and submitted fresh applications. They were put through stringent examinations and made it back to the WHO list, the multilateral agency said. After the USFDA issued its warning letter to Ranbaxy in 2008 on its Paonta Sahib facility in Himachal Pradesh, the WHO organised several inspections to see if similar issues affected the WHO-prequalified products, it said.
“One of these inspections was conducted in November 2008 by a team of six inspectors — three from WHO-PQP, one from the Therapeutic Goods Administration of Australia, one from Health Canada and one from the United Kingdom’s Medicines and Healthcare products Regulatory Agency.”
The checks included verification of source data, quality control and investigation of computer systems and related data. Some non-compliances were observed, but the company submitted documentation describing corrective and preventive actions, and these were found acceptable, the WHO said. “There was no evidence to warrant any further action by WHO-PQP” or other authorities, it added.
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