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Dear all,
Please advice how much Volunteers / Patients need for PMS Phase IV
Study & Advice me who are the CROs conducting PMS in National Level
India
Thanks & Regards
Govindaraj
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The following message was posted to: PharmPK
Dear Govindaraj
I do not think there is any need of fixed number of volunteers for
doing PMS Phase IV. There is no limit of voluntary (spontaneous)
reporting of adverse drug reactions. Secondly, the more the number of
patients' case reports are available with adverse drug reactions, the
more relevant and reliable is the Drug-ADR Association. There are now
many CROs who are engaged and working in PMS, but their sincerity is
doubtful as they all make tall claim regarding safety issues. No CRO
is officially designated or involved in National Pharmacovigilance
Program as Zonal, Regional or Peripheral Centre. National
Pharmacovigilance Programme (NPP) is a nationwide activity sponsored
and coordinated by the Central Drugs Standard Control Organisation,
New Delhi, to establish and manage a database of adverse drug
reactions occurring in the country.
The program in addition may help to create awareness about the adverse
drug reactions and to undertake necessary and timely steps in ensuring
a safer use of medicines among health professionals in India. Any
health related professional may report suspected adverse drug
reactions to these centre. The details of all these centres are
available at the website of CDSCO http://cdsco.nic.in
With kind regards,
Syed Ziaur Rahman, MD
Centre for Safety and Rational Use of Indian Systems of Medicine
Ibn Sina Academy of Medieval Medicine & Sciences
Aligarh 202002, India
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Dear Govind,
I wish to add some words on Dr. Syed Ziaur Rahman's reply on Indian
National Pharmacovigilance Program (NPP). Along with CDSCO, Society of
Pharmcovigilance, India (SOPI) is also involved in this. You can get
the details at
http://www.pharmacovigilance.co.in/home.html
Habeeb Ibrahim
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