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 Union Quimico Farmaceutica”, 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? “Recalling” Emcure 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. In February 2015, aseptic and GMP practices at Emcure’s operations had impacted product sterility and Emcure’s customer, Sagent Pharmaceuticals had to recall
their Atracurium Besylate injections. 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 IndiaIn 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. Fleming
Laboratories and Smruthi
Organics, have been on the FDA Import Alert list for quite some time now
and Sharon
Bio-medicine was issued a non-compliance report by the EDQM in 2013. Additional warnings
from across the borderWhile 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. Our viewWhile 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.
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