The regulatory agency said the findings
from FDA and WHO inspections call into
question the quality management system
in place at Semler, and thus on the
reliability of the data of all bioequivalence
studies.
MUMBAI: The European Medicines Agency
has recommended suspension of scores
of medicines tested by Semler Research –
an Indian clinical research organization –
based on findings by the US FDA and
WHO. The two agencies had raised
serious concerns related to data integrity
and manipulation of study samples
conducted by the clinical research firm.
The bioequivalence studies, necessary to
gain approvals – were done by the Indian
CRO for large generic companies
including Sandoz, Mylan Teva, Accord
Healthcare, Micro Labs and Zydus Cadila .
“The Agency has also recommended that
medicines currently being evaluated for
authorisation and which rely only on
bioequivalence studies from this
(Semler’s) site should not be authorised
until bioequivalence is demonstrated
using alternative data…,” a July 22
statement from EMA noted.
The issues of deviations found by the US
FDA were reported by ET in April last year
and involved substitution and
manipulation of subjects’ clinical
samples. The WHO had raised concerns
on the same grounds.
The European regulatory agency said the
findings from FDA and WHO inspections
call into question the quality management
system in place at Semler, and thus on
the reliability of the data of all
bioequivalence studies, including those
used to support marketing authorisation
applications in the EU.
However, the agency said that during the
evaluation process, alternative studies
were provided for a few of the medicines
and since those studies showed
bioequivalence, the CHMP (Committee for
Medicinal Products for Human Use) has
recommended that those medicines can
remain on the market. Those products
mainly belong to Lupin, Mylan and Aristo
Pharma. The EMA noted that if the
suspension leads to unavailability of
alternatives, the member state may
temporarily postpone its suspension in
the interest of patients.
Another leading Indian CRO GVK
Bioscience was also extensively probed
by the EMA, following which hundreds of
products tested by the firm were
suspended last year.

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