Regulatory Focus™ > News Articles > 10 > EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

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Posted 15 October 2018 | By Ana Mulero 

EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

3085 The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.
The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of suitability being irbesartan. This decision was based on the detected contamination of the losartan products manufactured by India-based Hetero Labs.
“National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution,” EMA said.
With the drug safety issue stemming from a Chinese valsartan supplier rapidly expanding to more countries, more companies and more medicines, the other sartans that EMA anticipates could be affected include candesartan and olmesartan. “The review into the presence of impurities in sartans and their potential effects in patients is ongoing,” EMA said.
The EMA’s update also informs of a decision to place the first China-based company that triggered the European response to the drug safety issue under increased supervision. The move directs EU authorities to supervise the manufacture of other active substances produced by Zhejiang Huahai “more closely” by monitoring the company’s implemented corrective actions and increasing the frequency of site inspections, EMA said.
“Marketing authorization holders for EU medicines will be required to perform additional tests on all active substances supplied by Zhejiang Huahai,” the agency added. This decision was based on the findings from EU and US inspections at the company’s site in Linhai, China. The visits revealed deficiencies in the way the company investigates impurities in its valsartan products.
Last month, the inspection findings prompted EMA to issue a statement of noncompliance to Zhejiang Huahai on the same day that the US Food and Drug Administration (FDA) placed the company on import alert. Both actions are intended to prevent manufacturers use of its valsartan.
As the valsartan scandal continues to unravel, regulatory agencies have been working in collaboration, leading some to question whether certain red flags could have helped mitigate the potential impact.
The drug safety issue surfaced in July with the move to recall certain valsartan-containing medicines across the EU over the reported presence of the first detected impurity known as N-nitrosodimethylamine (NDMA). The EMA, FDA and Health Canada reported last month the second impurity classified as probable human carcinogen, N-nitrosodiethylamine (NDEA), had also been detected in products containing valsartan supplied in bulk by Zhejiang Huahai.
Neither NDMA nor NDEA have been found in any other product made by Zhejiang Huahai, EMA noted. The agency reported in August estimates from its initial risk assessment for NDMA in medicines containing the company’s valsartan that indicated “the lifetime risk of cancer is low.” 
Low levels of NDEA have now been linked to Aurobindo Pharma’s irbesartan and Hetero Lab’s losartan. Low levels of NDMA were previously detected in the valsartan from a second China-based company, Zhejiang Tianyu. These three companies and Zhejiang Huahai are no longer authorized to supply medicines containing the contaminated active substances in the EU.


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