Full article reprinted from "PharmAsia News" - September 30, 2008
Find out why The cascading effect of U.S. FDA's enforcement action against India's largest drug maker Ranbaxy has reached the World Health Organization. On its website, WHO has observed that several inspections of Ranbaxy's Paonta Sahib site - most recently in June 2008 - revealed noncompliance with WHO good manufacturing practices standards.
Full article reprinted from "PharmAsia News" - September 30, 2008
The cascading effect of U.S. FDA's enforcement action against India's largest drug maker Ranbaxy has reached the World Health Organization. On its website, WHO has observed that several inspections of Ranbaxy's Paonta Sahib site - most recently in June 2008 - revealed noncompliance with WHO good manufacturing practices standards.
"After each inspection by the WHO Prequalification of Medicine Program, the company submitted corrective action plans to rectify these non compliances and in general the site was considered to be operating at an acceptable level of compliance with WHO GMP," the world body says.
Further elaborating on its moves against Ranbaxy, WHO said in a Sept. 17 note that it is closely monitoring the case and planning a series of extra-ordinary actions on top of its routine monitoring activities to confirm if Ranbaxy products prequalified by WHO continue to meet necessary requirements to ensure quality, safety and efficacy.
WHO says Ranbaxy has submitted several antiretroviral products for WHO prequalification since 2001. In total, Ranbaxy has 18 products prequalified by WHO and seven products currently under evaluation.
A recent import alert issued by U.S. FDA lists 30 products, including two - lamivudine and zidovudine - that are present in several WHO-prequalified products. Thus, the concerns FDA raises are relevant to prequalified products from Ranbaxy manufactured at the Paonta Sahib site, the world health body said.
WHO as requested clarification from Ranbaxy on the issues raised by FDA. WHO also is in close contact with FDA concerning Ranbaxy products based on the confidentiality agreement between the two institutions. WHO has been in contact with other national regulatory authorities, as well, in an effort to follow the matter closely. Most importantly, WHO is liaising with other UN agencies such as UNICEF and its partners on the issue.
Sounding a cautious tone, WHO says, "In case serious public health concerns arise in relation to any of the activities listed above, the WHO Prequalification of Medicines Programme will suspend the affected products from the list of WHO prequalified products and immediately inform stakeholders, including users and national regulators."
While FDA issues warning letters for noncompliance with manufacturing standards, the WHO Prequalification of Medicines Program issues "Notice of Concern" after an inspection is performed where noncompliance observations are made, such as GMP or good clinical practices violations.
As of now, WHO has not issued such a notice to Ranbaxy. Several regulators, including Health Canada, the New Zealand Health ministry and the U.K.'s Medicines and Healthcare products Regulatory Agency, are investigating Ranbaxy's manufacturing sites following FDA's action. In addition, three Ranbaxy drugs were recently suspended from the U.S. President's Emergency Plan for AIDS Relief in response to FDA's concerns.
- Vikas Dandekar
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Companies mentioned in this article
Ranbaxy
World Health Organization
