The U.S. FDA banned drug imports from the finished dosage form operations of Emcure Pharmaceuticals Ltd over concerns related to their manufacturing practices. As our previous analysis, four months ago, “Quality Alerts at Lupin, Hospira, Emcure and Uquifa”, had anticipated the problems at Emcure, we were not at all surprised.
Now that Emcure, a top 20 drug maker in India, joins the growing ranks of companies with compliance concerns, are there others who are likely to get cited next?
Emcure has been involved in multiple product recalls in recent times and while no warning letters have been posted yet, the reason for the product recalls were always, compliance concerns at Emcure.
At the same time, lack of assurance of product sterility was the reason cited by Heritage Pharmaceuticals (Emcure’s subsidiary in the U.S.) when they recalled their batches of Colistimethate & Rifampin injections.
Last year, Teva was forced to recall almost 40,000 bottles of products manufactured at Emcure because "laboratory testing was not followed in accordance with GMP requirements."
A ban on $500 million Emcure will impact U.S. pharmaceuticals
Emcure's plant in Hinjawadi in Pune, India has three finished dosage form facilities which, in our assessment, are covered by the import alert.
Emcure’s strength has been on producing injectable products and now it joins a growing list of sterile manufacturing plants where compliance is a concern. Concerns at sterile manufacturing operations of Hospira, Hikma Portugal, Bedford (which is now owned by Hikma) and others will make the import ban on Emcure have a significant impact on the US pharmaceutical market.
It is hence not surprising that eight injectable products, made at Emcure, have been exempted from the import ban, a position usually taken by the FDA to prevent drug shortages.
Privately held Emcure, with almost $500 million in sales and which counts private equity players like Bain Capital among its main investors, clearly has a tough road ahead.
Regulatory overhaul in India
In order to revive the brand image of the pharmaceutical industry in India, the government is planning to take several measures, which includes the overhauling of CDSCO, the regulatory body for drug quality standards in India.
With the Indian regulator planning to undertake a massive drug inspection exercise, there are chances that now, Indian companies will encounter many more domestic compliance challenges as well.
Warning Bells from the U.S.
Last week, the FDA published the list of companies who have not paid their GDUFA facility fees. The GDUFA facility fee is paid annually by generic companies to continue to do business in the United States.
Maybe it is time to wonder, why some companies are not paying the FDA? Especially since some on the list have made recent headlines due to problems in international regulatory inspections…
While PharmaCompass covered the compliance issues at Polydrug Laboratories (India) & IDT Biologika (Germany) recently, there are others whose regulatory concerns are also available for review in the public domain.
Additional warnings from across the border
While not on the GDUFA payment defaulter list, data integrity concerns at Chinese API manufacturer, Zhejiang Hisun have already made Health Canada issue a notice to voluntarily quarantine drugs, made or tested with API from Hisun.
Health Canada’s decision was based on a “trusted regulatory partner” so it would not be surprising if we see similar action from other agencies.
Signs of European trouble
In Europe, the EDQM has recently suspended some CEPs of European manufacturers like Polpharma (metoprolol tartrate & metoprolol succinate) and Synteco S.p.A (articaine hydrochloride & ropivacaine hydrochloride).
A CEP suspension does not always result in a non-compliance report, however, there is a high degree of correlation between the two activities.
While compliance issues at some of the companies mentioned above have not yet made headlines, at PharmaCompass, we strive to collate the latest industry developments to provide actionable intelligence so that we can continue to be your “trusted information partner”.
After all, like Health Canada, using real-time information and taking a proactive approach towards compliance, will always ensure the health of patients and in turn generate better business.