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 The medicines are now being reviewed by the European Medicines
Agency (EMA) on the recommendation of the German regulator, which
inspected Alkem's Taloja plant in western India last March.
Alkem was found to have engaged in "intentional misrepresentation"
of data and duplicated results of electrocardiogram (ECG) readings
of patients in trials, the German regulator said in a notice sent to
the EMA on March 24, 2016.
The notice and other information on the review dated April 1 was
seen by Reuters on the EMA website on Friday. (http://bit.ly/1Vp9VgP)
In recent years, India's GVK Biosciences and Quest Lifesciences were
found to have duplicated ECG data, resulting in the withdrawal of
approvals for hundreds of drugs last year. (http://reut.rs/1SFyorM).
The EMA said it was assessing the "benefit-risk" of certain
medicines that had received marketing approval based on trials
conducted by Alkem between March 2013 and March 2015.
The drugs include the antibiotic cefuroxime and rulizole, used to
treat the neurological disorder amyotrophic lateral sclerosis, sold
both by Alkem and Slovenia's Krka, the EMA said. Alkem was
conducting trials on the drugs for Krka. The German regulator made
Alkem aware of its findings on Sept. 8, 2015, according to the
notice. Mumbai-based Alkem did not immediately reply to requests for
comment on Friday. It said last month that UK regulator MHRA had
inspected the Taloja plant and made eight observations.
Krka did not immediately respond to an email seeking comment.
The German regulator said Alkem's quality management system "neither
avoided nor detected" the data manipulation. The regulator has urged
the EMA, the medicines regulator for the European Union, to take
necessary action and consider if impacted drugs need to be suspended
or recalled.
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Alkem, one of the fastest-growing drugmakers in India, debuted on
Indian stock exchanges in December, raising more than $200 million
in an offering that received an overwhelming response from
investors. Since the listing, its shares have dipped 3 percent.
Apart from conducting clinical trials for drug companies, it sells
generic versions of medicines ranging from anti-infectives,
anti-diabetics and anti-malaria drugs to 55 countries, including
United States and Europe.
The EMA's opinion will be considered by the European Commission,
which will take a final decision on the medicines, the EMA said.
(Reporting by Zeba Siddiqui in Mumbai; Editing by Muralikumar
Anantharaman)
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