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The following message was posted to: PharmPK
Dear All,
I would like to know whether bioequivalence facility has to take every
renewal from DCGI? suppose if the approval get expired further
bioequivalence study can be carried out?
With Regards
N Ramesh
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The following message was posted to: PharmPK
Dear N Ramesh
Please find my opinion:
I would like to know whether bioequivalence facility has to take every
renewal from DCGI?
I could not understand the objective of this question. But overall
answer is 'YES'.
suppose if the approval get expired further bioequivalence study can
be carried out?
The answer is 'NO'.
Thanks
Dr Sajjad A Desai
Assistant Medical Director
212/2, Hadapsar, Pune. 411028
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The following message was posted to: PharmPK
Dear Sir,
My doubt is At present our approval on the facility expired (Date of
approval).
One can conduct further study or after renewal we have to do the study.
im working with MNC company. That why i raised this issue sir.
Thank your reply.
With Regards
N.Ramesh
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The following message was posted to: PharmPK
Dear N.Ramesh
The answer is very simple.You can conduct the study after having
renewal/inspection from DCGI.
Thanks
Sajjad
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hi ramesh,
Before expiry of the approval, did you applied for the renewal of
licence. If yes, when. Because we have to give time to visit DCGI,
person to inspect the facilities. But as per your mail you are
mentioning only about the expiry of the approval. After expiring when
you are going for the renewal then you will have to wait until you get
the renewal of licence. you cant conduct the study.
Already if you have submitted the proposal, contact to the office of
DCGI, they will give some suggestions/ information.
devisha
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The following message was posted to: PharmPK
Dear devisha,
Not yet applied.
With regards
N.Ramesh
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hi ramesh,
Immediately go for applying till you get you have not supposed to go
for the BE studies. The reason is after expiriing you are going to
applying for the renewal. Otherwise you can proceed further( ie
before expiring if you have applied for).
I think this is ok for you.
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Dear Ramesh and others;
Pardon my ignorance, what is DGCI? If this is an international
organization expand on the abbreviation. A harmless advise is if you
write a detailed question (not few pages but not one sentence either),
this gives better grasp on people who may have a helpful answer.
Prasad
Prasad NV Tata, MS, Ph.D., FCP
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134
e-mail: prasad.tata.aaa.covidien.com
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Hi Prasad
DGCI (Drugs Controller General of India) is the regulatory body of
India.
Ziyaur
--
Dr. Ziyaur Rahman
Post Doctoral Research Associate
Department of Pharmaceutics
School of Pharmacy
112 Faser Hall
University of Mississippi
University, MS 38677
Email-rahman.-at-.olemiss.edu
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