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	<title>PILMAN &#187; FDA</title>
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		<title>US Biosimilar Overhaul: A Breakthrough Moment or a Strategic Test for Indian Pharma</title>
		<link>http://www.tapanray.in/us-biosimilar-overhaul-a-breakthrough-moment-or-a-strategic-test-for-indian-pharma/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=us-biosimilar-overhaul-a-breakthrough-moment-or-a-strategic-test-for-indian-pharma</link>
		<comments>http://www.tapanray.in/us-biosimilar-overhaul-a-breakthrough-moment-or-a-strategic-test-for-indian-pharma/#comments</comments>
		<pubDate>Sun, 09 Nov 2025 08:01:06 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[affordable]]></category>
		<category><![CDATA[biosimilar]]></category>
		<category><![CDATA[Breakthrough]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Guidelines]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[moment]]></category>
		<category><![CDATA[overhaul]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[Reform]]></category>
		<category><![CDATA[Strategic]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[Tapan Ray]]></category>
		<category><![CDATA[test]]></category>
		<category><![CDATA[US]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=10996</guid>
		<description><![CDATA[On 31 October 2025, the Economic Times (ET) headline— “US biosimilar norms to keep local drug cos in good health” - quickly became one of the most discussed topics across India’s biopharmaceutical circles. For India, which is transitioning from a global generics’ powerhouse &#8230; <a href="http://www.tapanray.in/us-biosimilar-overhaul-a-breakthrough-moment-or-a-strategic-test-for-indian-pharma/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>Shifting Pharma Supply Chain Strategy From Global To Local</title>
		<link>http://www.tapanray.in/shifting-pharma-supply-chain-strategy-from-global-to-local/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=shifting-pharma-supply-chain-strategy-from-global-to-local</link>
		<comments>http://www.tapanray.in/shifting-pharma-supply-chain-strategy-from-global-to-local/#comments</comments>
		<pubDate>Mon, 08 Jun 2020 00:00:14 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[America]]></category>
		<category><![CDATA[chain]]></category>
		<category><![CDATA[China]]></category>
		<category><![CDATA[Drug]]></category>
		<category><![CDATA[export]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[global]]></category>
		<category><![CDATA[import]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[lobbyists]]></category>
		<category><![CDATA[local]]></category>
		<category><![CDATA[logistics]]></category>
		<category><![CDATA[market]]></category>
		<category><![CDATA[Pharmacy]]></category>
		<category><![CDATA[Procurement]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[reevaluating]]></category>
		<category><![CDATA[shifting]]></category>
		<category><![CDATA[strategy]]></category>
		<category><![CDATA[Supply]]></category>
		<category><![CDATA[supply-chain]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[Tapan Ray]]></category>
		<category><![CDATA[top]]></category>
		<category><![CDATA[United States]]></category>
		<category><![CDATA[US]]></category>
		<category><![CDATA[vulnerability]]></category>
		<category><![CDATA[Vulnerable]]></category>
		<category><![CDATA[World]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=10120</guid>
		<description><![CDATA[Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the &#8230; <a href="http://www.tapanray.in/shifting-pharma-supply-chain-strategy-from-global-to-local/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Protect Generic Drug Margin Moving Up The Value Chain</title>
		<link>http://www.tapanray.in/protect-generic-drug-margin-moving-up-the-value-chain/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=protect-generic-drug-margin-moving-up-the-value-chain</link>
		<comments>http://www.tapanray.in/protect-generic-drug-margin-moving-up-the-value-chain/#comments</comments>
		<pubDate>Mon, 03 Dec 2018 00:00:03 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[180-day]]></category>
		<category><![CDATA[ANDA]]></category>
		<category><![CDATA[commissioner]]></category>
		<category><![CDATA[commoditization]]></category>
		<category><![CDATA[commodity]]></category>
		<category><![CDATA[Complex]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[erosion]]></category>
		<category><![CDATA[Exclusivity]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[formulation]]></category>
		<category><![CDATA[generics]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[innovative]]></category>
		<category><![CDATA[Medicines]]></category>
		<category><![CDATA[price]]></category>
		<category><![CDATA[Ray]]></category>
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		<category><![CDATA[Tapan Ray]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=9276</guid>
		<description><![CDATA[As an innovative drug molecule goes off-patent, it paves the way for market-entry of cheaper generic equivalents of the same. It benefits not just the patients, but all generic drug players awaiting this opportunity. But, in case of even those &#8230; <a href="http://www.tapanray.in/protect-generic-drug-margin-moving-up-the-value-chain/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>A ‘Toxin’ Delaying Success of Biosimilar Drugs</title>
		<link>http://www.tapanray.in/a-toxin-delaying-success-of-biosimilar-drugs/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=a-toxin-delaying-success-of-biosimilar-drugs</link>
		<comments>http://www.tapanray.in/a-toxin-delaying-success-of-biosimilar-drugs/#comments</comments>
		<pubDate>Mon, 06 Aug 2018 00:00:46 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Biologic]]></category>
		<category><![CDATA[biosimilar]]></category>
		<category><![CDATA[commissioner]]></category>
		<category><![CDATA[delay]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Glaritus]]></category>
		<category><![CDATA[Guidelines]]></category>
		<category><![CDATA[immunogenicity]]></category>
		<category><![CDATA[Interchangeability]]></category>
		<category><![CDATA[interest]]></category>
		<category><![CDATA[Lantus]]></category>
		<category><![CDATA[launch]]></category>
		<category><![CDATA[Medicines]]></category>
		<category><![CDATA[original]]></category>
		<category><![CDATA[Patient]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[Sanofi]]></category>
		<category><![CDATA[Self]]></category>
		<category><![CDATA[serving]]></category>
		<category><![CDATA[success]]></category>
		<category><![CDATA[Tapan]]></category>
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		<category><![CDATA[Toxin]]></category>
		<category><![CDATA[US]]></category>
		<category><![CDATA[wockhardt]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=9086</guid>
		<description><![CDATA[The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important &#8230; <a href="http://www.tapanray.in/a-toxin-delaying-success-of-biosimilar-drugs/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>&#8216;Rigged&#8217; Payment System Limits Biosimilar Access</title>
		<link>http://www.tapanray.in/rigged-payment-system-limits-biosimilar-access/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=rigged-payment-system-limits-biosimilar-access</link>
		<comments>http://www.tapanray.in/rigged-payment-system-limits-biosimilar-access/#comments</comments>
		<pubDate>Mon, 02 Apr 2018 00:00:05 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Access]]></category>
		<category><![CDATA[Biologic]]></category>
		<category><![CDATA[biosimilar]]></category>
		<category><![CDATA[branded]]></category>
		<category><![CDATA[commissioner]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[el dorado]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Interchangeability]]></category>
		<category><![CDATA[large]]></category>
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		<category><![CDATA[launch]]></category>
		<category><![CDATA[litigations]]></category>
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		<category><![CDATA[molecule]]></category>
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		<category><![CDATA[Payment]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[rigged]]></category>
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		<category><![CDATA[states]]></category>
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		<category><![CDATA[Zarxio]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=8908</guid>
		<description><![CDATA[As often discussed, market entry of biosimilars, in general, brings a new hope not just for many patients, but also to biosimilar drug manufacturers &#8211; planning to get marketing approvals of these drugs in the United States, the El Dorado &#8230; <a href="http://www.tapanray.in/rigged-payment-system-limits-biosimilar-access/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>&#8216;Indian Drug Control World’s Weakest: Pharma Trade Bodies Working At Cross Purposes&#8217;</title>
		<link>http://www.tapanray.in/indian-drug-control-worlds-weakest-pharma-trade-bodies-working-at-cross-purposes/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=indian-drug-control-worlds-weakest-pharma-trade-bodies-working-at-cross-purposes</link>
		<comments>http://www.tapanray.in/indian-drug-control-worlds-weakest-pharma-trade-bodies-working-at-cross-purposes/#comments</comments>
		<pubDate>Mon, 25 Apr 2016 00:00:25 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Act]]></category>
		<category><![CDATA[associations]]></category>
		<category><![CDATA[ban]]></category>
		<category><![CDATA[BMJ]]></category>
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		<category><![CDATA[center]]></category>
		<category><![CDATA[Code]]></category>
		<category><![CDATA[control]]></category>
		<category><![CDATA[Corruption]]></category>
		<category><![CDATA[cross-purposes]]></category>
		<category><![CDATA[DCGI]]></category>
		<category><![CDATA[Department]]></category>
		<category><![CDATA[DoP]]></category>
		<category><![CDATA[Drug]]></category>
		<category><![CDATA[Editorial]]></category>
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		<category><![CDATA[Ethics]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[import]]></category>
		<category><![CDATA[India]]></category>
		<category><![CDATA[Indian]]></category>
		<category><![CDATA[mandatory]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=7612</guid>
		<description><![CDATA[&#8220;In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened,&#8221; said the Secretary of the Department of Pharmaceuticals (DoP) &#8211; V K Subburaj at an event in New-Delhi on April &#8230; <a href="http://www.tapanray.in/indian-drug-control-worlds-weakest-pharma-trade-bodies-working-at-cross-purposes/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>The Curious Conundrum of New Drugs Approval Process</title>
		<link>http://www.tapanray.in/the-curious-conundrum-of-new-drugs-approval-process/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=the-curious-conundrum-of-new-drugs-approval-process</link>
		<comments>http://www.tapanray.in/the-curious-conundrum-of-new-drugs-approval-process/#comments</comments>
		<pubDate>Mon, 18 Jan 2016 00:00:05 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[Alatrofloxacin]]></category>
		<category><![CDATA[approval]]></category>
		<category><![CDATA[Aprotinin]]></category>
		<category><![CDATA[big]]></category>
		<category><![CDATA[BMJ]]></category>
		<category><![CDATA[Canada]]></category>
		<category><![CDATA[CDC]]></category>
		<category><![CDATA[Clinical]]></category>
		<category><![CDATA[Cochrane]]></category>
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		<category><![CDATA[curious]]></category>
		<category><![CDATA[data]]></category>
		<category><![CDATA[disclosure]]></category>
		<category><![CDATA[Drotrecogin alfa]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[Economist]]></category>
		<category><![CDATA[EFPIA]]></category>
		<category><![CDATA[EMA]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[full]]></category>
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		<category><![CDATA[India]]></category>
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		<category><![CDATA[London]]></category>
		<category><![CDATA[Lumiracoxib]]></category>
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		<category><![CDATA[Matthew Herder]]></category>
		<category><![CDATA[New]]></category>
		<category><![CDATA[Open]]></category>
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		<category><![CDATA[process]]></category>
		<category><![CDATA[Propoxyphene]]></category>
		<category><![CDATA[public]]></category>
		<category><![CDATA[Ray]]></category>
		<category><![CDATA[registry]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Rofecoxib]]></category>
		<category><![CDATA[Rosiglitazone]]></category>
		<category><![CDATA[Safety]]></category>
		<category><![CDATA[Sibutramine]]></category>
		<category><![CDATA[Tamiflu]]></category>
		<category><![CDATA[Tapan]]></category>
		<category><![CDATA[Tapan Ray]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=7360</guid>
		<description><![CDATA[Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were &#8230; <a href="http://www.tapanray.in/the-curious-conundrum-of-new-drugs-approval-process/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		</item>
		<item>
		<title>Is Drug Price Control The Key Growth Barrier For Indian Pharma Industry?</title>
		<link>http://www.tapanray.in/is-drug-price-control-the-key-growth-barrier-for-indian-pharma-industry/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=is-drug-price-control-the-key-growth-barrier-for-indian-pharma-industry</link>
		<comments>http://www.tapanray.in/is-drug-price-control-the-key-growth-barrier-for-indian-pharma-industry/#comments</comments>
		<pubDate>Mon, 19 Oct 2015 00:00:14 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
		<category><![CDATA[1995]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=7183</guid>
		<description><![CDATA[The corollary of the above headline could well be: “Are drug price hikes the key growth driver for the Indian Pharmaceutical Market (IPM)?” Whenever the first question, as appears in the headline of this article: “Is drug price control a &#8230; <a href="http://www.tapanray.in/is-drug-price-control-the-key-growth-barrier-for-indian-pharma-industry/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<title>Nutraceuticals: An Emerging Opportunity in The Gray Area Between Pharma And Nutrition</title>
		<link>http://www.tapanray.in/nutraceuticals-an-emerging-opportunity-in-the-gray-area-between-pharma-and-nutrition/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=nutraceuticals-an-emerging-opportunity-in-the-gray-area-between-pharma-and-nutrition</link>
		<comments>http://www.tapanray.in/nutraceuticals-an-emerging-opportunity-in-the-gray-area-between-pharma-and-nutrition/#comments</comments>
		<pubDate>Mon, 17 Nov 2014 00:00:37 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
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		<category><![CDATA[nutrition]]></category>
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		<guid isPermaLink="false">http://www.tapanray.in/?p=6190</guid>
		<description><![CDATA[Close association between nutrition and health has assumed a historical relevance. Growing pieces of evidence, even today, suggests that nutritional intervention with natural substances could play an important role, especially in the preventive healthcare. The World Health Organization (WHO) too &#8230; <a href="http://www.tapanray.in/nutraceuticals-an-emerging-opportunity-in-the-gray-area-between-pharma-and-nutrition/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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		<title>Pioglitazone Conundrum: Should The Drug Regulator Step Over The Line?</title>
		<link>http://www.tapanray.in/pioglitazone-conundrum-should-the-drug-regulator-step-over-the-line/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=pioglitazone-conundrum-should-the-drug-regulator-step-over-the-line</link>
		<comments>http://www.tapanray.in/pioglitazone-conundrum-should-the-drug-regulator-step-over-the-line/#comments</comments>
		<pubDate>Mon, 08 Jul 2013 00:00:54 +0000</pubDate>
		<dc:creator>Tapan Ray</dc:creator>
				<category><![CDATA[Pharma]]></category>
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		<category><![CDATA[withdrawal]]></category>

		<guid isPermaLink="false">http://www.tapanray.in/?p=2883</guid>
		<description><![CDATA[Recent order of the Indian drug regulator to withdraw all formulations of the well known, yet controversial, anti-diabetic drug &#8211; Pioglitazone from the domestic market has created a flutter in the country, ruffling many feathers at the same time. Withdrawal &#8230; <a href="http://www.tapanray.in/pioglitazone-conundrum-should-the-drug-regulator-step-over-the-line/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
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