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Geokad ☆ Canada, 2014-02-18 22:06 (4101 d 21:22 ago) Posting: # 12443 Views: 7,624 |
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Greetings, Last month, a memorandum was issued by the Office of Drugs Controller General (India) requiring that centers conducting BA/BE studies must be approved by the CDSCO. Does anyone know if this applies to international centers conducting studies for Indian sponsors? — Regards, Geokad |
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bharat narnavar ☆ India, 2014-02-24 12:41 (4096 d 06:47 ago) @ Geokad Posting: # 12476 Views: 6,210 |
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ElMaestro ★★★ Denmark, 2014-02-24 13:00 (4096 d 06:27 ago) @ bharat narnavar Posting: # 12477 Views: 6,245 |
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Hello bharat, ❝ I guess it will be not applicable for international centers. FDA has recently had some beef with Indian generic drug makers and their subcontractors, and due to those worries FDA are increasing their oversight in the country. A worst case scenario is a generalised import ban that targets not drug makers but an entire country. It could potentially lead to a complete collapse of India's pharma industry. Accordingly, I think CDSCO's move is a partially politically motivated step that serves to increase trust from overseas agencies in an effort to keep the Pharma Industry afloat. That may only happen if at some point the quality stamp is extended to international trials centers. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2014-02-26 01:07 (4094 d 18:20 ago) @ ElMaestro Posting: # 12499 Views: 6,119 |
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Dear ElMaestro, ❝ FDA has recently had some beef with Indian generic drug makers and their subcontractors, and due to those worries FDA are increasing their oversight in the country. A worst case scenario is a generalised import ban that targets not drug makers but an entire country. I'm not sure I could totally blame them considering the recent accumulation of data integrity issues reported in warning letters. See the latest posted this week. Jugaad... ❝ It could potentially lead to a complete collapse of India's pharma industry. It surely could. Pity for those people doing a good job. I wouldn't cry for the rest. (Don't misunderstand me: what I just wrote is not targeted against India, I would react the same way whatever the country. But this accumulation of fraudulent behavior is just too much). — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2014-02-26 14:41 (4094 d 04:47 ago) @ Ohlbe Posting: # 12506 Views: 6,075 |
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Dear Ohlbe, ❝ I'm not sure I could totally blame them considering the recent accumulation of data integrity issues reported in warning letters. See the latest (...) Wow, thanks for bringing this to my attention. Some really, really scary sh!t going on there. Interesting that the FDA are commenting, actually almost helping, the inspectee define the appropriate role of the Data Integrity Consultant. Or let's call her/him a DIC to spare the keyboard. The FDA is clearly telling the inspectee here that even though the actual errors, e.g. tampering with the balances, may have been done by lab personnel they want an ID of people in management who are and/or were responsible and their potential present influence can be contained as a PA. This is an elegant and useful way of saying that the inspectee can't take the easy way out and just point fingers at some lab technicians, fire them and expect that it all goes away. Finally, I completely love the term "management behaviour", which is part of what the DIC must look at. There's clearly an unmeet need here; I imagine ASQ, CfPIE, RABQSA etc will soon establish trainings called something like "Assessing management behaviours for DICs". [CfPIE: Feel free to trademark that title. It's all yours.] — Pass or fail! ElMaestro |
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