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 Reuters reported on Friday that German authorities had accused the
company of manipulating heart readings of patients in some trials
for the antibiotic cefuroxime and the brain disorder drug rulizole,
following an inspection of Alkem's plant in Taloja in western India
in March 2015.
The European Medicines Agency (EMA) is investigating the medicines
after Germany reported its findings to the EMA and urged it to take
action in a report that was posted on the EMA website.
Alkem said in a statement on Saturday that the company had responded
to the German authorities with a "robust remediation plan" and would
also submit "suitable clarification" to the EMA.
Similar findings by European regulators concerning manipulation of
electrocardiogram data at two other Indian firms, GVK Biosciences
and Quest Lifesciences, led to the recall of nearly 700 medicines
last year.
Alkem said the inspection concerned studies conducted by the company
between March 2013 and March 2015 on two products, one of which is
selling, while the other is yet to reach the market. It did not name
the products. (http://bit.ly/1Te0bTs)
It also said it had changed staff, upgraded equipment and improved
its quality assurance systems at the Taloja plant since Germany's
inspection.
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Alkem, among the fastest-growing drugmakers in India, said sales
from Europe made up less than 1 percent of its total revenue in the
nine months to December 2015.
Still, the company's shares were down 5 percent at 0459 GMT on
Monday, after falling as much as 8 percent earlier in the day -
their lowest since Feb. 29. The company debuted on the Indian stock
exchanges in December.
(Reporting by Zeba Siddiqui in Mumbai; Editing by Richard Pullin)
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