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	<title>Best Online Pharmacy Review &#187; My Story</title>
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		<title>Indian pharmaceutical suppliers and the U.S. FDA</title>
		<link>http://www.bestonlinepharmacyreview.com/indian-pharmaceutical-suppliers-and-the-u-s-fda/</link>
		<comments>http://www.bestonlinepharmacyreview.com/indian-pharmaceutical-suppliers-and-the-u-s-fda/#comments</comments>
		<pubDate>Wed, 27 Jan 2010 17:34:21 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[FDA Quality]]></category>
		<category><![CDATA[My Story]]></category>
		<category><![CDATA[Suppliers]]></category>
		<category><![CDATA[Canadian pharmacy]]></category>
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		<category><![CDATA[generic meds]]></category>
		<category><![CDATA[Indian]]></category>

		<guid isPermaLink="false">http://www.bestonlinepharmacyreview.com/?p=322</guid>
		<description><![CDATA[The purpose of this article is to generate confidence in Indian suppliers that serve Canadian and online pharmacies. India commands the dominant world market share as manufacturer and exporter of generic product. Indian suppliers are the generic sourcing choice for Canadian and online pharmacies because globalization is driving them toward U.S. FDA compliance in the <a href='http://www.bestonlinepharmacyreview.com/indian-pharmaceutical-suppliers-and-the-u-s-fda/'>[...]</a>]]></description>
			<content:encoded><![CDATA[<p><a href="http://www.bestonlinepharmacyreview.com/wp-content/uploads/2010/01/AARP-coverage-gap1.jpg"><img class="alignleft size-thumbnail wp-image-430" title="Indian suppliers and the U.S. FDA" src="http://www.bestonlinepharmacyreview.com/wp-content/uploads/2010/01/AARP-coverage-gap1-150x150.jpg" alt="" width="150" height="150" /></a>The purpose of this article is to <strong><span style="text-decoration: underline;">generate confidence in Indian suppliers</span></strong> that serve Canadian and online pharmacies. India commands the dominant world market share as manufacturer and exporter of generic product.</p>
<p>Indian suppliers are the generic sourcing choice for Canadian and online pharmacies because globalization is driving them toward <strong><span style="text-decoration: underline;">U.S. FDA compliance </span></strong>in the move to more collaborative relationships with the US, EU and Japan. <a href="http://www.mckinsey.com/locations/india/mckinseyonindia/pdf/India_Pharma_2015.pdf"><strong>Learn more</strong></a><strong>.</strong></p>
<p>Be sure that your online vendor uses FDA compliant suppliers. This page represents <a href="http://www.4rx.com/manufacturers.html"><strong>proper disclosure</strong></a> that would be reassuring for a consumer.</p>
<p>Evolution of the Indian pharmaceutical industry:</p>
<p>In the <span style="text-decoration: underline;">50’s and 60’s</span> India had minimal domestic pharmaceutical production.  They were dependent on western sources for medicines which they could ill afford. The <strong><span style="text-decoration: underline;">Indian government instituted tariffs and liberalized patent laws</span></strong> to nurture a domestic pharmaceutical industry. The patent laws allowed Indian companies to copy expensive original preparations by foreign firms and produced these by means of alternative production procedures. This had the effect of allowing Indian manufactures to <span style="text-decoration: underline;">duplicate western formulations before the expiration of the patent</span> in the country of origin, typically the US. This environment caused western pharmaceutical companies to withdraw from India.</p>
<p>From the <span style="text-decoration: underline;">70’s to 2005</span> the Indian pharmaceutical industry experienced double digit growth. They became expert at producing western preparations using a slightly modified process to stay within Indian patent law. They became known as the <span style="text-decoration: underline;">“Pharmacy of the poor”.</span> Low wages and high educational standards lent it self well to super charging the growth of the pharmaceutical industry. Focusing on generic production <span style="text-decoration: underline;">eliminated developmental risk</span> as well as prohibitively expensive research dollars.  India holds 20% of the world generic market but 2% of the pharmaceutical world market. 22% of total generic production is exported and of that <strong><span style="text-decoration: underline;">80% goes to US and the EU</span></strong>.</p>
<p><span style="text-decoration: underline;">After the 2005</span> patent law reform, which resulted in the adoption of the Agreement on Trade-Related Aspects of <strong><span style="text-decoration: underline;">Intellectual Property Rights</span></strong>, the industry entered a more collaborative environment with western pharmaceutical industry than during the earlier developmental period. This reorientation of the industry resulted in these important changes.</p>
<p>1. A segment still focuses on <span style="text-decoration: underline;">generic as its prime business.</span> In this segment 80% of generic production is targeted for US, EU and Japan.</p>
<p>2. A major segment is focusing on development of new medicines. This has <span style="text-decoration: underline;">spawned new research relationships</span> between Indian firms and western giants like Ely Lily.</p>
<p>3. <span style="text-decoration: underline;">Contract manufacturing</span> for western giants is the last segment of the reorientation.</p>
<p><span style="color: #ff0000;">The most significant change resulting from patent reform is movement of the entire Indian pharmaceutical industry toward <strong><span style="text-decoration: underline;">US FDA compliance</span></strong> due to the new western focus on so many touch points. <span style="color: #000000;">The US, EU and Japan are the most lucrative world markets. Since the US FDA governs the major segment of export target market the move to FDA standards serves the reorientation of the Indian pharmaceutical industry.</span></span></p>
<p>Here are some relevant excerpts and website links.</p>
<p>The Indian <strong>pharmaceutical industry</strong> is also <a href="http://www.economywatch.com/business-and-economy/pharmaceutical-industry.html"><strong>getting increasingly </strong><strong>U.S.</strong><strong> FDA compliant</strong> </a>to harness the growth opportunities in areas of <span style="text-decoration: underline;">contract manufacturing </span>and research. Indian companies such as Ranbaxy, Sun Pharma, and Dr. Reddy&#8217;s are increasingly focusing on <strong><span style="text-decoration: underline;">tapping the </span></strong><strong><span style="text-decoration: underline;">U.S.</span></strong><strong><span style="text-decoration: underline;"> generic market</span></strong>. Recently, Ranbaxy Laboratories Ltd has received a tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine tablets (150 mg), a medicine used in treating HIV infection. This tentative approval has been granted under the US President&#8217;s Emergency Plan for AIDS Relief Initiative (PEPFAR).</p>
<p>Wage costs in the Indian drugs industry come to only about 30% of the European level or 20% of the US level. Overall drugs manufacturing in India is up to <strong><span style="text-decoration: underline;"><a href="http://www.dbresearch.com/PROD/DBR_INTERNET_EN-PROD/PROD0000000000224095.pdf">50% cheaper than in western industrial countries</a></span></strong>.</p>
<p>Here is an overview of the Indian pharmaceutical regulatory structure. Click on full screen and use finger to advance through slides.<span style="font-size: small; font-family: Times New Roman, Times, serif;"><span style="font-size: x-small;"> </span></span></p>
<div id="__ss_1073601" style="width: 425px; text-align: left;"><a style="font: 14px Helvetica,Arial,Sans-serif; display: block; margin: 12px 0 3px 0; text-decoration: underline;" title="Pharmaceuticals  Registration In India" href="http://www.slideshare.net/chitrasp/Pharmaceuticals-Registration-in-India">Pharmaceuticals Registration In India</a><object style="margin: 0px;" classid="clsid:d27cdb6e-ae6d-11cf-96b8-444553540000" width="425" height="355" codebase="http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=6,0,40,0"><param name="allowFullScreen" value="true" /><param name="allowScriptAccess" value="always" /><param name="src" value="http://static.slidesharecdn.com/swf/ssplayer2.swf?doc=PharmaceuticalsRegistrationinIndia-123566563681-phpapp01&amp;rel=0&amp;stripped_title=Pharmaceuticals-Registration-in-India" /><param name="allowfullscreen" value="true" /><embed style="margin: 0px;" type="application/x-shockwave-flash" width="425" height="355" src="http://static.slidesharecdn.com/swf/ssplayer2.swf?doc=PharmaceuticalsRegistrationinIndia-123566563681-phpapp01&amp;rel=0&amp;stripped_title=Pharmaceuticals-Registration-in-India" allowscriptaccess="always" allowfullscreen="true"></embed></object></div>
<div style="font-size: 11px; padding-top: 2px; font-family: tahoma,arial; height: 26px;">View more <a style="text-decoration: underline;" href="http://www.slideshare.net/">documents</a> from <a style="text-decoration: underline;" href="http://www.slideshare.net/chitrasp">chitrasp</a>.</div>
<p>These circumstances generated the investigation which produced this information.</p>
<p>The event:</p>
<p>In November of 2006 I had a second heart attack. This event was in addition to the first heart attack and stent in 2002 and a 2005 a bad stress test report led to two more stents. This second heart attack was the first event which resulted in heart tissue loss. This loss was due to blockage from clotting in the LAD diagonal artery.</p>
<p>In August 2006 we moved from NJ to GA. I had no contact with a Cardiologist at this point.  The November 2006 heart attack left me at the mercy of the ER to produce a qualified Intervention Cardiologist. The surgery was to no avail. The artery was too firmly blocked to get a stent implanted. The LAD diagonal was lost. I was put on a <strong><span style="text-decoration: underline;">Coreg a beta blocker</span></strong> designed for post heart attack patients.  Here is the difference between domestic brand and Canadian generic sourced from India.</p>
<div><span style="mso-bidi-font-weight: bold;"> </span></div>
<div><span style="mso-bidi-font-weight: bold;"><span style="font-size: small;"> </span></span></div>
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<td width="151" height="22">Product</td>
<td width="78">Wal-Mart</td>
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<td width="96">Canada Rx</td>
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<td width="110">Canada Rx</td>
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<td>Per Pill</td>
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<td>Per Pill</td>
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<td>% Savings</td>
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<td height="21">Coreg</td>
<td>$2.25</td>
<td></td>
<td>$0.50</td>
<td></td>
<td><strong> <span style="color: #ff0000;"> 78%</span></strong></td>
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<p>Validate per pill pricing  <a href="http://www.4rx.com/online-pharmacy/categories/heart-cholesterol/generic-carvedilol.html">Carvedilol  (Generic Coreg)</a></p>
<p>The story:</p>
<p>My plan was to get the med from Canadian online to save money. At this point I was three years short of being eligible for Medicare. I had no insurance. Investigation into private coverage produced the same answer from several insurers. <strong><span style="text-decoration: underline;">I was uninsurable</span> </strong>because of my cardio history. They said they could do something with corporate coverage but not private. Ultimately the whole 2006 event cost me around $10,000 cash. The hospital gave a 40% discount and the doctor around 30% for a lump sum cash payment. The alternative to cash would have been a pay schedule with interest.</p>
<p>In the follow up visit I asked the doc for a one month brand prescription which was called into a local pharmacy as well as a hand written script to fax to Canada. The reason for the one month local prescription was to accommodate the two to three week delivery time for Canadian generic product that would come from an Indian supplier. I found that local pharmacies will only give you a thirty day supply but <strong><span style="text-decoration: underline;">Canadian or online pharmacies will fill a ninety or one hundred eighty day order. </span></strong></p>
<p>When I went to pick up the prescription the <strong><span style="text-decoration: underline;">local pharmacist frightened me</span></strong>. He was very adamant that the non-domestic suppliers universally produced unsafe, impure and ineffective products. After this unsettling experience I was determined to get to the bottom of this quality issue. So took the one month order of the brand from him and went home to investigate. Obviously I was very interested in getting proper effectiveness from this med.</p>
<p>I went on the computer and searched the word Coreg. This produced some Canadian pharmacies which had a generic. I looked up the generic name a Cardivas. This was very comforting. The word Cardivas let me to <a href="http://www.intaspharma.com/pharmaceuticals_global_operations_contract_manufacturing.html">Intas Pharmaceutical</a> a manufacturer in India. The above link shows that Intas is FDA approved and inspected.</p>
<p>These images show the 2005 and 2006 stent procedure. I had bypass surgery in 2008. I asked the 2006 surgeon &#8220;you think I would be better served with a bypass?&#8221; He said &#8220;no&#8221;. The bypass was done at the Atlanta VA by <a href="http://www.surgery.emory.edu/cardio_surgery/cardio_vega.htm">Dr. David Vega</a> and the Emory University heart transplant team which does heart procedures at the VA twice per week. I felt very blessed to have that world class team do the procedure.</p>
<p>Heart images 2005-2006</p>
<p>Click on image to enlarge, click on enlarged image to return to this page.</p>

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		<title>Pharmacy prices too expensive?</title>
		<link>http://www.bestonlinepharmacyreview.com/pharmacy-prices-too-expensive/</link>
		<comments>http://www.bestonlinepharmacyreview.com/pharmacy-prices-too-expensive/#comments</comments>
		<pubDate>Sun, 13 Dec 2009 17:49:06 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[FDA Quality]]></category>
		<category><![CDATA[My Story]]></category>
		<category><![CDATA[Rx Savings]]></category>
		<category><![CDATA[Suppliers]]></category>
		<category><![CDATA[AARP]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Mind boggling savings]]></category>
		<category><![CDATA[Save]]></category>
		<category><![CDATA[Save up to 90%]]></category>

		<guid isPermaLink="false">http://www.bestonlinepharmacyreview.com/?p=152</guid>
		<description><![CDATA[This blog is about the prohibitively high cost of prescription drugs. I found that online pharmacies can save up to 90% on certain big dollar pharmaceuticals. In most cases online pharmacies can provide meds for less than your aggregate spend for drug plan co-pay and premium. Please see personal experience in the last paragraph. There <a href='http://www.bestonlinepharmacyreview.com/pharmacy-prices-too-expensive/'>[...]</a>]]></description>
			<content:encoded><![CDATA[<p><a href="http://www.bestonlinepharmacyreview.com/wp-content/uploads/2009/12/cheapprescriptions-thumb.jpg"><img class="alignleft size-thumbnail wp-image-543" title="Save 90%" src="http://www.bestonlinepharmacyreview.com/wp-content/uploads/2009/12/cheapprescriptions-thumb-150x150.jpg" alt="" width="150" height="150" /></a>This blog is about the prohibitively high cost of prescription drugs. I found that online pharmacies can <strong>save up to 90%</strong> on certain big dollar pharmaceuticals. In most cases online pharmacies can <strong>provide meds for less </strong>than your aggregate spend for drug plan co-pay and premium. Please see<strong> personal experience </strong>in the last paragraph. <strong></strong></p>
<p>There are currently over 40 million people who are uninsured or under insured and <strong>cannot afford</strong> <strong>prescription medications.</strong> Most of us have felt the pinch of health care expenses. It seems that we contribute more to our premiums and co-pays than ever before.</p>
<p>There are a half a million American’s falling out of the job market every month. Paying extend medical benefits is in many cases prohibitivly expensive if you loose your income. There is a large segment of the population that needs <strong>relief from the high cost of pharmaceuticals</strong>. I am offering a solution to the high cost of meds which will provide relief for this growing segment of the population.<strong></strong></p>
<p><strong></strong>I was introduced to online pharmacy savings by my father-in-law who used this avenue to manage his <strong>AARP-United Healthcare drug plan allowance</strong>. <a href="personal-experience-with-online-pharmacies">Learn more</a>.</p>
<p>There are considerations related to <strong>safety, purity and effectiveness</strong> that are insured by our FDA (Food and Drug Administration). <a href="FDA/">Learn more</a>.</p>
<p>We all want safe and reliable pharmaceuticals. There are <strong>offshore supplier issues</strong> that concern each of us. We want to know that the source of our pharmaceuticals are regulated and inspected by proper authority.  This fits together in a complex relationship of vendor, supplier and regulator. <a href="suppliers/">Learn more</a>.</p>
<p>The upcoming health care reform legislation highlights the urgency of resolving some of the prohibitively high cost of services. The new legislation targets the insurance industry that controls healthcare delivery.  This implies the <strong>high cost of drugs will not be resolved </strong>by the new legislation. I believe there will continue to be<strong> price benefits to be gained by using online pharmacies. </strong>The cost of drugs will continue to be prohibitively expensive for millions of Americans<strong>.</strong></p>
<p><strong></strong>I would like to close this article with a <strong>positive personal experience</strong>. These offshore suppliers are able to <strong>pass on mind boggling savings</strong>. They can produce FDA quality product for about <strong>five cents on the dollar</strong>. I will give two examples. First example: I ordered some generic product that was to be in tablet form and it came as a capsule.  My interest was being able to cut the tablet and get a more economical per pill cost.  I called and told the vendor’s representative, I was expecting a tab and got a cap. The representative said no problem we will send a replacement tab order. I enquired about returning the cap order. The representative said they were not expecting to have the incorrect cap order returned. Whew &#8211; I was impressed. I got to <strong>keep a double quantity for the price of one order</strong>. But I thought how can they do that?  The implication is that production costs must cover this eventuality. I don’t know the precise details but the message was clear. <strong>They can deliver meds at a dramatically reduced cost</strong>.  Second example: Some vendors offer a 20% coupon for initial order and a reorder price reduction of 10% or 20% more product.  So there is a pretty big margin some where. All this <strong>on top of a 90% lower price</strong> point than paid in the first world markets.  Think about that. &#8211; Wow!</p>
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