New pharmaceutical clinical
trials in India have ground to a
halt, with the approval process
stalled by the Drug Controller
General of India (DCGI) which is
now taking extreme caution in
evaluating submissions.
Between Jul and Aug 2013, the
DCGI had received up to 1,122
applications - 285 of which were
approved by India’s New Drug
Committee but just 162 were
cleared by the DCGI, according to
India’s Pharmabiz.com website.
Then the clinical trial process was
further stalled last year when the
Supreme Court of India issued an
order in October staying all of the
162 DCGI approvals.
The court’s judgement said
it considered that the number
of uncontrolled clinical trials
sponsored by drug companies
across India outstripped the
country’s ability to safely monitor
them, potentially resulting in
“hundreds of deaths” from
unethical practices.
Only 25 Indian clinical trials have
received approval to proceed in
the first half of 2014.The above article was sent to subscribers in Pharmacy Daily's issue from 04 Jul 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 04 Jul 14
OVER a quarter of a million people have sbeen vaccinated against influenza this year through community pharmacies in Queensland, reported the Pharmacy Guild of Australia.
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