nobody
nothing

2014-10-14 13:44
(3452 d 22:24 ago)

Posting: # 13700
Views: 2,898
 

 Current BE guideline India? [Regulatives / Guidelines]

The guidance link for India is apparently outdated due to re-design of the homepage, anyways, the latest guideline for BE studies in India I could find is this link:

...at drugscontrol.org

Can anyone confirm that this is the latest version of this document?

Many thanx in advance!

nobody


(...'caus nobody knows...)

Kindest regards, nobody
nobody
nothing

2014-10-15 13:42
(3451 d 22:26 ago)

@ nobody
Posting: # 13712
Views: 2,398
 

 Current BE guideline India?

...may I observe that the link in database has been updated to the link I found and deduce from this that it actually IS the current version? (?)

Kindest regards, nobody
Helmut
★★★
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Homepage
Vienna, Austria,
2014-10-15 15:04
(3451 d 21:03 ago)

@ nobody
Posting: # 13713
Views: 2,418
 

 Confirmation pending

Ὀδυσσεύς

❝ ...may I […] deduce from this that it actually IS the current version? (?)


You shouldn’t. Given the numbers of members from India I updated the guideline-collection because I prefer an (outdated?) document over a link leading to limbo.

[image]

Would be nice if our Indian colleagues – who are very active in asking questions – would be as quick in answering one of ours.

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nobody
nothing

2014-10-16 20:38
(3450 d 15:29 ago)

@ Helmut
Posting: # 13734
Views: 2,559
 

 Confirmation pending

http://www.pharmabiz.com/NewsDetails.aspx?aid=84185&sid=1

What does this mean for products for the Indian market? No need for making up studies any more?

According to sources, the Drugs Consultative Committee (DCC) of the Union health ministry, which comprises all the state drug controllers besides senior health ministry officials including the DCGI, has recommended to the ministry that BA/BE studies in respect of drugs manufactured in the country should be insisted whenever there are issues relating to patient safety and variable bioavailability. “As the infrastructure for conduct of such studies is not uniformly available in the country, it cannot be implemented as a rule”, the DCC recommended.

gruuuuuuusel...

Kindest regards, nobody
Helmut
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Vienna, Austria,
2014-10-16 23:16
(3450 d 12:51 ago)

@ nobody
Posting: # 13735
Views: 2,408
 

 Terrible…

❝ What does this mean for products for the Indian market? No need for making up studies any more?


At least this is what I understand as well.

Remember the Ranbaxy Story and one of the official statements?

Backing pharma major Ranbaxy, who has been accused of marketing sub-standard medicines, the health ministry Friday said there was nothing wrong with the quality of its drugs.
“There are misconceptions about Ranbaxy producing sub-standard drugs. There was something wrong with the manufacturing process, but the quality of the drugs was fine,” said Jagdish Prasad, Director General of Health Services.
“In the production of the medicines, the company may have forgotten to follow one or two steps prescribed by the US FDA (Food and Drug Administration), but that does not mean that the drugs are sub-standard,” he added.

I translate from Newspeak:

Cmon, they have tested TT|RR instead of RT|TR. So what? That’s just a super­fluous, nit­picking require­ment of the damn arrogant Americans our boys may [sic] have forgotten [sic] to follow. Of course, drugs marketed in India are excellent!

Given that, the recent statement doesn’t surprise me at all.

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nobody
nothing

2014-10-16 23:31
(3450 d 12:36 ago)

@ Helmut
Posting: # 13736
Views: 2,343
 

 Terrible…

...and apparently there are no "limited capacities" for BE-studies for the European or US market. Very strange...



But maybe this bio-thing is indeed totally overrated
http://www.rawstory.com/rs/2013/04/fda-secretly-retests-100-different-drugs-after-testing-company-admits-its-work-was-all-fraudulent/

...ask him:
http://ca.linkedin.com/pub/chinna-pamidi/a/38/277


Edit: Merged with follow-up post. [Helmut]

Kindest regards, nobody
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