nobody nothing 2014-10-14 13:44 (3453 d 06:20 ago) Posting: # 13700 Views: 2,909 |
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The guidance link for India is apparently outdated due to re-design of the homepage, anyways, the latest guideline for BE studies in India I could find is this link: ...at drugscontrol.org Can anyone confirm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 (3452 d 06:22 ago) @ nobody Posting: # 13712 Views: 2,408 |
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...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 ★★★ Vienna, Austria, 2014-10-15 15:04 (3452 d 04:59 ago) @ nobody Posting: # 13713 Views: 2,428 |
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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 You shouldn’t. Given the numbers of members from India I updated the guideline-collection because I prefer an (outdated?)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. Would be nice if our Indian colleagues – who are very active in asking questions – would be as quick in answering one of ours. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
nobody nothing 2014-10-16 20:38 (3450 d 23:26 ago) @ Helmut Posting: # 13734 Views: 2,568 |
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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 ★★★ Vienna, Austria, 2014-10-16 23:16 (3450 d 20:47 ago) @ nobody Posting: # 13735 Views: 2,418 |
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❝ 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. 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.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
nobody nothing 2014-10-16 23:31 (3450 d 20:32 ago) @ Helmut Posting: # 13736 Views: 2,353 |
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...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 |