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Dear All,
We have problem in getting IEC approval. Is it necessary that all the
BA/BE protocols on DCGI approved molecules need to be submitted to
DCGI for NOC (No objection certificate) before conducting the studies
in India?
What is the standard procedure followed in Indian industry? What are
the recommendations as per the Indian law?
Please clarify. This will be helpful for whole industry.
Regards,
Dr.Shiva Murthy.N
Head-Clinical Operations
Fortis Clinical Research Limited
Faridabad
Ph-0129-4090900
Fax-0129-4090924
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Hi,
My understanding is that to conduct a BA/BE study in India (for
commercial purpose) except for 'OLD DRUGS' (molecules approved more
than 4 years earlier), all others require a 'NOC' from the office of
the DCGI.
I also look forward to additional information from others on this.
Regards,
Pankaj.
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The following message was posted to: PharmPK
Dear Dr. Murthy,
As per the new rules at DCGI, all BA/BE protocols need to be submitted
to DCGI for approval (NOC) before initiating BA/BE study. This is a
practice which is currently followed in Industry.
Regards
Dr. Tausif Ahmed
Metabolism and Pharmacokinetics
Ranbaxy Research Laboratories
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The following message was posted to: PharmPK
Dear Dr Murthy,
I do agree with you that there is some degree of confusion in regards
to the DCGI /NOC for BA/BE studies ,as per the "schedule Y " for any
New drug as per the drugs and cosmetic act, NOC is to be obtain from
the DCGI for its any clinical evaluation or BA/BE studies.Below is
the common rules which most of the sponsors are following.
1. For any drug product IR/MR approved and marketed for more than
4years and by more than 4 companies in india no DCGI /NOC is required.
2. For any drug product IR/MR approved globally but not approved and
marketed in india DCGI/NOC.is required.
3. For any New drug product ( New strength, new dosage form,
different release profile,different indication, IR to MR conversion,
New combination )
For all the molecules which falls in to this categories a DCGI
application is to be made along with the approved protocol prior to
the study conduct. Please refer " schedule Y" for under standing new
drug as per drugs and cosmetic act.
Manoj K Vishwakarma
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hi manoj,
rihgtly you mentioned about the NOC regarding BA/BE studies.
Here we have to see the term "NEW DRUGS". If you see definition of
new drugs as per the drugs and cosmetics act, NOC is not required for
the older molecules. It is only meant for newer molecules and i
think we can add this also in new drugs list ie molecule with higher
doses first time in india.
devisha
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hi pankaj,
Is there any reference to the following"except for 'OLD
DRUGS' (molecules approved more than 4 years earlier) are exempted
from DCGI NOC" in the Schedule Y or any CDSCO or DCGI documents.
rgds
ashis
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Ashis,
As already suggested by the others, its probably the Drugs &
Cosmetics Act that refers to "new" & "Old" drugs in India.
Regards,
Pankaj.
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The following message was posted to: PharmPK
Dear Shiva Murthy,
If the molecule is available from last four years in India, you need
not to
apply for NOC for BE studies, the IEC/IRB approval is sufficient to
conduct
BE study. If the molecule is not available from last four years, you
have to
get NOC from DCGI to conduct BE study.
regards,
Srinivasa Reddy.E
Research Analyst
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dear shiva N. Murthy,
If the molecule and strenth is available in india no need of DCGI
approval letter. If the molecule strength is not available in india,
then you have to take the DCGI approval.
Regards,
veeresh
Research associate
Manipal AcuNova
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The following message was posted to: PharmPK
Dear Veeresh and Shiva
I would further add to your observation that approval for BE is
required for only new product,
New product means approval of the product by DCGI is less than 4 year
old. For rest of the product approval for BE is not required.
Dr Ashish Mungantiwar
General Manager-Medical Services
and Head-Bioequivalence
Macleods Pharmaceuticals Limited
India
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