【讨论】WHO Statement on Ranbaxy Medicines
这个帖子发布于 12 年零 5 天前，其中的信息可能已发生改变或有所发展。
On 13 Ma y 2013, the US Justice Department announced 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 (including Sotret, gabapentin, and ciprofloxacin) made at two Ranbaxy facilities in India. Ranbaxy agreed to pay a US$ 150 million penalty and to settle civil claims under the False Claims Act and related State laws for US$ 350 million.
WHO has prequalified a number of finished pharmaceutical products (FPPs) manufactured by Ranbaxy Laboratories Limited (hereafter referred to as Ranbaxy). Currently prequalified Ranbaxy FPPs are listed on the web site of the WHO Prequalification of Medicines Programme (WHO-PQP) at www.who.int/prequal and in Annex 1.
Fraudulent behaviour by a pharmaceutical manufacturing company is to be condemned — for both public health and legal reasons. Regulation of pharmaceutical products is designed in part to detect and eliminate such behaviour since it can jeopardize the safety and efficacy of medicines.
In 2004, WHO-PQP detected and reported various malpractices by Ranbaxy that, together with other, similar practices identified in later investigations by the United States Food and Drug Administration (USFDA), led to the aforementioned May 2013 legal action. Throughout this time, WHO-PQP and its regulatory partners have cooperated closely to monitor Ranbaxy products. Indeed, since 2004, international cooperation between stringent regulators and WHO-PQP has been enhanced to allow early sharing of regulatory intelligence and to facilitate coordinated action, when necessary.
At present, there is no evidence that any of the Ranbaxy products currently included on the WHO List of Prequalified Medicinal Products are of unacceptable quality.
WHO-PQP continues to closely monitor and cooperate with other regulators on all cases of suspected sub-standard medicines. If it obtains information that merits removal of any products from the WHOPQP list, it will not hesitate to act.
WHO has prequalified a number of finished pharmaceutical products (FPPs) manufactured by Ranbaxy Laboratories Limited (hereafter referred to as Ranbaxy). Currently prequalified Ranbaxy FPPs are listed on the web site of the WHO Prequalification of Medicines Programme (WHO-PQP) at www.who.int/prequal and in Annex 1.
Fraudulent behaviour by a pharmaceutical manufacturing company is to be condemned — for both public health and legal reasons. Regulation of pharmaceutical products is designed in part to detect and eliminate such behaviour since it can jeopardize the safety and efficacy of medicines.
In 2004, WHO-PQP detected and reported various malpractices by Ranbaxy that, together with other, similar practices identified in later investigations by the United States Food and Drug Administration (USFDA), led to the aforementioned May 2013 legal action. Throughout this time, WHO-PQP and its regulatory partners have cooperated closely to monitor Ranbaxy products. Indeed, since 2004, international cooperation between stringent regulators and WHO-PQP has been enhanced to allow early sharing of regulatory intelligence and to facilitate coordinated action, when necessary.
At present, there is no evidence that any of the Ranbaxy products currently included on the WHO List of Prequalified Medicinal Products are of unacceptable quality.
WHO-PQP continues to closely monitor and cooperate with other regulators on all cases of suspected sub-standard medicines. If it obtains information that merits removal of any products from the WHOPQP list, it will not hesitate to act.
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