On March 3, Toyama Prefecture issued business suspension orders to Nichi-Iko for the issue of its manufacturing and sales of pharmaceuticals manufactured in a manner different from that on the approval document. It issued an order to suspend operations as a pharmaceutical manufacturer to the Toyama Plant 1 for 32 days from March 5 to April 5 and an order to suspend operations as a holder of marketing authorization for pharmaceuticals to Nichi-Iko for 24 days from March 5 to March 28, following the Pharmaceuticals and Medical Devices Act. For the past ten years, the company has been improperly remedying non-conforming pharmaceuticals in quality tests to become conforming products. This followed Kobayashi Kako, which Fukui Prefecture ordered to suspend operations for 116 days, the longest ever. The administrative punishment against Nichi-Iko, one of the largest generic drug manufacturers, has led to a decline in generic drugs’ confidence.
Deviations started more than ten years ago
The company voluntarily recalled as many as 75 items from April last year to mid-January this year, which was followed by an on-site investigation conducted by Toyama Prefecture and the Pharmaceuticals and Medical Devices Agency (PMDA) at its Toyama Plant 1 in late February.
The investigation results have revealed that the company at Toyama Plant 1 processed non-conforming products in the quality test so that they would become a conforming product using a manufacturing method different from that on the approval documents. And it also did not take appropriate measures to address the results of non-conformity in the quality tests and other tests.
From around 2011 at the latest, the Deviation Control Manager had convened meetings called the “Deviation Meetings” following the procedure manual, where deviant actions against non-conformities at shipment tests and other measures were discussed and implemented.
It has been revealed a case at the meetings above that the initial test results were rejected, and the products were shipped by adopting the conforming results of retesting of the same sample as the initial test or of a different sample. In addition, there were other cases where shipment tests had been conducted after the products underwent reprocessing that were not mentioned in the manufacturing instruction record to obtain the conforming results to the standard.
From around 2014 to 2016, the number of occurrences of deviations and the frequency of deviation meetings increased against the backdrop of increasing demand for generic products, and inappropriate remedies continued to occur after April 2017.
Besides, since around 2009, with the increased numbers of production items and packaging formats, stability tests and other tests have not been conducted due to a shortage of human resources and physical facilities compared to the required number of the tests. As of February last year, many stability tests had not been conducted.
The Manufacturing Supervisor of Pharmaceuticals at Toyama Plant 1 failed to manage and supervise the appropriate manufacturing and quality control of pharmaceuticals. Toyama Prefecture judged that these violated the Pharmaceuticals and Medical Devices Act and issued a 32-day business suspension order for manufacturing.
The prefectural government also pointed out the reasons for the punishment against the pharmaceutical marketing business: the company had failed to take the necessary care to manufacture and market its products properly and to make proper quality control of its products. The prefectural government ordered the company to suspend its operations for 24 days as a marketer on the ground that the company had manufactured and sold pharmaceuticals at its Toyama Plant 1 using methods that differed from those specified in the approval documents, and that the Marketing Director of Pharmaceuticals of the company had failed to perform necessary quality control operations, which constituted a violation of the Pharmaceuticals and Medical Devices Act.
However, the order to suspend manufacturing operations excludes operations such as handling complaints and returns; quality control of shipped products; and storage management of products, raw materials, and materials. Also, the company will continue to ship products in stock for which the market shipment decision was completed before March 4, even during the period of the administrative punishment. Operations related to Post-marketing safety management of products and complaints and returns will be excluded from the administrative penalty for Manufacturing and Sales Business.
With sales of 190 billion yen for the fiscal year ending March 2020, Nichi-Iko is positioned as a major generic drug maker. The company handles more than 1,000 items, which many hospitals and pharmacies use. Therefore, it is inevitable that the business suspension orders against the company will impact the stable supply of generics.
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