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	<title>Vaatsalya Clinical</title>
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	<link>http://vaatsalyaclinical.com</link>
	<description>independent clinical trials audit company</description>
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		<title>Schedule Y1 set to check fly-by-night operators in clinical trial sector</title>
		<link>http://vaatsalyaclinical.com/?p=92</link>
		<comments>http://vaatsalyaclinical.com/?p=92#comments</comments>
		<pubDate>Fri, 07 Aug 2009 05:29:10 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[Schedule Y1]]></category>

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		<description><![CDATA[The Schedule Y1 Draft Rules, which are under scrutiny by the Clinical Research Organizations (CROs) in the country, have been broadly welcomed by most of them. Key provisions of the Rules namely 122DA, 122DAA and 122 DAB are expected to check the fly-by-night operators who are rampant in the sector.
The proposed draft, approved by Drug [...]]]></description>
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		<title>Now In INDIA, all human clinical trials to be registered.</title>
		<link>http://vaatsalyaclinical.com/?p=82</link>
		<comments>http://vaatsalyaclinical.com/?p=82#comments</comments>
		<pubDate>Mon, 13 Jul 2009 11:15:03 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[Register human Clinical trials]]></category>

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		<description><![CDATA[BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for the first time that all clinical trials taking place across the country in all areas of health &#8211; new drugs, treatments, therapies, surgical procedures and new medical devices &#8211; must [...]]]></description>
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		<title>DCGI setting up Pharma Zones in India</title>
		<link>http://vaatsalyaclinical.com/?p=81</link>
		<comments>http://vaatsalyaclinical.com/?p=81#comments</comments>
		<pubDate>Tue, 26 May 2009 06:15:12 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[Pharma Zones in India]]></category>

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		<description><![CDATA[The Drugs Controller General of India (DCGI), India&#8217;s home grown equivalent of FDA of the US is setting up a EXIM port office in Bangalore.
 
According to an DCGI topper, the export-import center in Bangalore International Airport will help pharma makers in Bangalore in having a hassle-free dedicated export and import place for pharmaceuticals products.
 
“This is [...]]]></description>
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		<title>NEW DIABETES DRUG APPROVED WITHOUT TRIAL</title>
		<link>http://vaatsalyaclinical.com/?p=80</link>
		<comments>http://vaatsalyaclinical.com/?p=80#comments</comments>
		<pubDate>Sat, 02 May 2009 11:14:24 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>

		<guid isPermaLink="false">http://vaatsalyaclinical.com/?p=80</guid>
		<description><![CDATA[New Delhi: A new drug to combat diabetes, which is administered orally and not injected, was given a marketing approval by the Drugs Controller General of India (DCGI) without being put through the mandatory human clinical trials, highlighting a possible lapse in Indian laws dealing with the testing and approval of drugs.
 
The drug, Oral Recosulin, [...]]]></description>
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		<title>ICMR comes out strict draft norms on clinical trials</title>
		<link>http://vaatsalyaclinical.com/?p=79</link>
		<comments>http://vaatsalyaclinical.com/?p=79#comments</comments>
		<pubDate>Mon, 16 Mar 2009 07:13:18 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[ICMR]]></category>

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		<description><![CDATA[NEW DELHI: Mothers undergoing clinical trials which harm their unborn child may soon be able to demand compensation from researchers conducting the clinical trials.
 
According to Indian Council of Medical Research&#8217;s draft guidelines for compensation to participants for research related injury in India, &#8220;compensation will have to be paid to a child injured in-utero through the [...]]]></description>
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		<title>Law in offing to tighten regulation of clinical trials</title>
		<link>http://vaatsalyaclinical.com/?p=78</link>
		<comments>http://vaatsalyaclinical.com/?p=78#comments</comments>
		<pubDate>Mon, 23 Feb 2009 10:54:12 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[Law]]></category>

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		<description><![CDATA[NEW DELHI: There are no laws at present to penalize and monitor pharma companies, which have messed up or violated norms while conducting global clinical trials for testing drugs in India to avoid instances like patients&#8217; deaths.Last year, an infant died during a clinical trial on whom multinantional Wyeth&#8217;s advanced pneumonia vaccine was being tested [...]]]></description>
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		<title>Phase 0 &#8211; Microdosing strategy in clinical trials</title>
		<link>http://vaatsalyaclinical.com/?p=77</link>
		<comments>http://vaatsalyaclinical.com/?p=77#comments</comments>
		<pubDate>Fri, 13 Feb 2009 04:50:40 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[Phase 0]]></category>

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		<description><![CDATA[Drug development is an activity that is long, complex and expensive. In 2004, attrition in the drug development paradigm prompted the US Food and Drug Administration (FDA) to introduce its &#8216;Critical Path&#8217; document, which highlighted the serious discordance between major scientific advances and limited drug development process. One issue addressed was that of microdosing. The [...]]]></description>
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		<title>India to Conduct 5% Global Clinical Trials by 2012</title>
		<link>http://vaatsalyaclinical.com/?p=76</link>
		<comments>http://vaatsalyaclinical.com/?p=76#comments</comments>
		<pubDate>Thu, 05 Feb 2009 06:18:22 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>

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		<description><![CDATA[



India is fast emerging as a preferred destination for conducting global clinical trials due to multiple reasons and is forecasted to conduct around 5% of the global clinical trials by 2012.
New Delhi, India &#8211; India is fast becoming one of the biggest hubs for conducting global clinical trials. In 2007, the country conducted around 220 [...]]]></description>
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		<title>USFDA SETS UP OFFICES IN INDIA</title>
		<link>http://vaatsalyaclinical.com/?p=75</link>
		<comments>http://vaatsalyaclinical.com/?p=75#comments</comments>
		<pubDate>Fri, 30 Jan 2009 10:35:34 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[USFDA OFFICE]]></category>

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		<description><![CDATA[NEW DELHI: Consumers in India and US can now benefit from the enhanced safety of food, drugs and medical devices as the US Food and Drug Administration has set up its offices in India
 
US officials of Department of Health and Human Services, Mike Leavitt and Von Eschenbach, who were in India for the inauguration of [...]]]></description>
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		<title>Audit report on Wyeth’s clinical trial</title>
		<link>http://vaatsalyaclinical.com/?p=74</link>
		<comments>http://vaatsalyaclinical.com/?p=74#comments</comments>
		<pubDate>Wed, 28 Jan 2009 11:50:24 +0000</pubDate>
		<dc:creator>prashanth</dc:creator>
				<category><![CDATA[GCP Audits]]></category>
		<category><![CDATA[DCGI followup]]></category>

		<guid isPermaLink="false">http://vaatsalyaclinical.com/?p=74</guid>
		<description><![CDATA[New Delhi: An audit by India’s drugs quality regulator has found a clinical trial sponsored by Wyeth Pharmaceutical Ltd and monitored by GVK Biosciences Pvt Ltd has violated protocol, standard operating procedure and good clinical practices norms mandatory in the country.
The office of the drugs controller general of India, or DCGI, issued warning letters on [...]]]></description>
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