(Updates with company statement)
TOKYO, July 31 The Japanese unit of Novartis AG
apologised on Thursday for nfailing to report to
authorities in a timely manner side-effects of its leukaemia
drugs, in the company's latest scandal in the country.
Novartis Pharma KK, the Swiss drugmaker's wholly owned local
subsidiary, said Japan's Ministry of Health, Labour and Welfare
ordered the company to improve its practices after the company
did not report side-effects of its Gleevec and Tasigna leukaemia
treatments until around April.
The ministry said serious side-effects must be reported
within a month of discovery. Media reports said such
side-effects had been known between April 2013 and January 2014.
"We deeply regret that we have allowed this situation to
arise, and offer our deepest apologies to our patients, their
families, medical professionals, as well as the public," the
company said in a statement.
"We take it very seriously, that side-effects, which should
be extremely important to any pharmaceutical company, were not
Earlier in July, Tokyo prosecutors said they would charge
the unit and a former employee in connection with allegations of
data manipulation to promote its best-selling blood pressure
The prosecutors office in June arrested Nobuo Shiraishi on
allegations that he gave false data to researchers whose work
was used for advertising.
(Reporting by Ritsuko Ando; Editing by Chris Gallagher and Ryan