Pharmacovigilance in India - Warnings to the Industry

[Guest guest]

In the last week of July 2011, the deputy DCGI issued warning letters to

numerous domestic pharma companies in India warning them to submit PSURs

(Periodic Safety Update Reports) for the products granted approvals (new

strengths/ dosage forms of old molecules too) in the last 24 months. Even small

companies have received numerous such letters.

Most of the Pharma companies have still not reacted while some of them sent

liasoners to DCGI. The DCGI warned them to submit PSURs or else their licences

shall be terminated.

Although these steps are taken in good sense by the Pharmacovigilance Experts,

many are skeptical with regards to staff adequacy at DCGI office who could

handle these reports.

Regards,

Manoj

> > > >

> > > > Hello,

> > > > The next discussion will run from 26-29 Aug 2011 on " ADR Monitoring "

> > > which will

> > > > be moderated by Dr Gitanjali Kothiyal.

> > > > Welcome Dr.Geetanjali and please take over Netrum from 25th

> > > Aug.evening.Please

> > > > introduce your self before starting the discussion.

> > > > Kunda Gharpure

> > > >

> > >

> > >

> > >

> >

> >

> >

> > --

> > Dr.Manoj Swaminathan MBBS, MPH

> >

>