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hi all,
I would like to know is there any organisation or body to issue
certification for GCP and GLP for BE studies in india.
If you know kindly give the details.
thanks in advance.
devisha.
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The following message was posted to: PharmPK
Dear Devisha,
For getting GLP certification in India, you have to apply to National
GLP compliance monitoring committee, DST, Govt. of India.
The website for this is http://www.indiaglp.gov.in/.
For getting the GCP certification, you need to contact the Central Drug
Standard Control Organisation (CDSCO0).
The website for this is http://cdsco.nic.in/
Hope this helps
Thnx
Tausif Ahmed, Ph.D.
Metabolism and Pharmacokinetics Department
Ranbaxy Research Laboratories
India
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hi tausif
Indian government is providing GLP certification for non-clinical
only ie for pre-clinical and not for BE studies. If they are
providing that GLP certification kindly give me the details.
Regarding GCP:
In cdsco website they have not mentioned the details of GCP
certification.
kindly give the details if you know.
devisha.
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