Western drugmakers are very concerned about the quality of active pharmaceutical ingredients coming out of China and India since those two countries now manufacture an estimated 70% to 80% of APIs. That also means they have few places to turn if those two countries don't make the grade.
That is why there was some concern about the European Union's directive that beginning July 2, 2013, all foreign APIs be certified by an authority of the exporting nation that they meet the same GMPs that EU producers meet.
India, at least, says it will be prepared to meet the deadline.
"The government will appoint the required competent authority in two weeks time. Our compliance with the new EU norms will be completed well before the July deadline," P.V. Appaji told The Hindu Business Line. Appaji is director-general of India's drug regulator, the Pharmaceutical Export Promotion Council of India (Pharmexcil). His comments followed a meeting among the Health Ministry, Pharmexcil and Indian trade groups.
The EU directive, passed in 2011, gives a pass to countries to which it has granted exemptions. So far, only Switzerland and Israel have sought exemptions, reports in-Pharma Technologist, and none have so far been granted. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom raised concerns earlier this year on whether India and China would be able to meet the deadline and urged the EU "to engage" with them as quickly as possible, in-Pharma Technologist says.
China has been of particular concern in the U.S. after 80 deaths and hundreds of illnesses in 2008 were tracked back to tainted heparin from China. Chinese authorities have tried to crack down but problems there with substandard API makers are an open secret. The FDA has three offices in China now, and says within 5 years, it will inspect foreign API and drug makers at least once every two years as it does in the U.S.
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