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<ul><li>The <keyword id="6354977" type="ORGANIZATION" weightage="20" keywordseo="Supreme-Court">Supreme Court</keyword> has ordered a fresh enquiry of banned combination drugs after repeated reviews and recommendations from <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>’s drug advisory panel. </li><li>The Court announced its decision while hearing a plea from drug manufacturers <keyword id="45692" type="DOMAIN" weightage="20" keywordseo="Piramal-Healthcare">Piramal Healthcare</keyword>, <keyword id="78710" type="COMPANY" weightage="20" keywordseo="GlaxoSmithKline">GlaxoSmithkline</keyword> and Juggat Pharma who have challenged the ban. </li><li>India’s drug advisory panel has said these drug combinations could be potentially toxic to consumers and lack therapeutic justification. </li></ul> A week after the government <a href="https://www.businessinsider.in/indian-government-bans-several-painkillers-diabetes-and-antibiotic-drugs-over-safety-concerns/articleshow/65793205.cms">banned</a> the sale and distribution of over 328 ‘fixed dose combination’ drugs including several painkillers over safety concerns, the Supreme Court has lifted the <a href="https://www.livemint.com/Politics/LuFyd157Sb7PocoD5JtaZL/Supreme-Court-lifts-ban-on-sale-of-Saridon-and-2-other-drugs.html">ban</a> on popular painkiller <keyword id="1840022" type="PERSON" weightage="20" keywordseo="Saridon">Saridon</keyword> and two other drugs citing a technicality. A Supreme Court bench announced its decision while hearing a plea from drug manufacturers Piramal Healthcare, GlaxoSmithkline and Juggat Pharma who claimed their combination drugs should be allowed as they were first manufactured and granted regulatory clearance before 1988, the cut-off year for the government’s current ban. Earlier this month, the Supreme Court had directed the government to conduct yet another enquiry to evaluate the safety of at least 15 fixed dose combination drugs that were <a href="https://indianexpress.com/article/india/sc-allows-sale-of-saridon-3-other-drugs-5361027/">reportedly</a> manufactured before 1988. It was not immediately clear if Saridon, Piriton expectorant and Dart, the other two drugs granted relief by the court, would still be subject to fresh safety tests. The Supreme Court ordered the fresh enquiry of these combination drugs after repeated reviews and recommendations from India’s drug advisory panel, the Drugs Technical Advisory Board, which has said these drug combinations could be potentially toxic to consumers and lacked therapeutic justification. The most recent ban came three years after the panel had cited similar concerns recommending an outright ban before being ordered to conduct another review by the Supreme Court late last year. A pharmaceutical trade group, the Federation of Pharma Entrepreneurs, representing makers of FDCs affected by the ban has <a href="https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-exempts-saridon-piriton-expectorant-from-governments-ban-list/articleshow/65839739.cms">claimed</a> the government and the safety review panel have not followed due process in instituting the ban. Pharma companies have also <a href="https://indianexpress.com/article/india/sc-allows-sale-of-saridon-3-other-drugs-5361027/">contended </a>the Drug Technical Advisory Board’s review report behind the ban was never given to them. A long battle The government on its part has been seeking to ban these combination drugs -- which contain two or more active ingredients -- for nearly a decade. The review and recommendations have been ongoing for years with India’s Drugs Technical Advisory Board behind these repeated recommendations. According to <a href="https://timesofindia.indiatimes.com/india/govt-bans-popular-painkiller-327-other-unsafe-fixed-dose-drugs/articleshow/65790311.cms">estimates</a> by All India Drug Action Network, one of the petitioners behind the ban, problematic FDCs in India makes up a quarter of the total pharma market in India valued at ₹1.3 trillion ($14 billion) “The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” the drug network said in a recent <a href="https://aidanindia.wordpress.com/">statement. </a>

Here’s why the Supreme Court has exempted Saridon from the ban on FDCs

<ul><li>The ban affects an estimated 6,000 brands of ‘fixed dose combination’ drugs.</li><li>A drug review panel deems these drugs potentially toxic. </li><li>Popular painkiller <keyword id="1840022" type="PERSON" weightage="20" keywordseo="Saridon">Saridon</keyword> and skin ointment <keyword id="6875076" type="UNKNOWN" weightage="20" keywordseo="panderm">Panderm</keyword> among those banned.</li></ul>The government on Wednesday banned the sale and distribution of over 328 ‘fixed dose combination’ drugs and restricted six others over safety concerns, a move that affects an estimated 6,000 brands of such <keyword id="306491" type="DOMAIN" weightage="20" keywordseo="FDC">FDC</keyword> drugs. Among the brands that have been banned include the popular painkiller Saridon; Panderm, a skin ointment; Diabetes drug <keyword id="6875077" type="UNKNOWN" weightage="20" keywordseo="gluconorm">Gluconorm</keyword> PG; and antibiotic drug Lupidiclox, the Times of <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> <a href="http://timesofindia.indiatimes.com/articleshow/65790311.cms?utm_source=contentofinterest&amp;utm_medium=text&amp;utm_campaign=cppst">reported.</a> The government had sought to restrict the combination drugs as early as 2010 followed by a review by India’s drug advisory panel, the Drugs Technical Advisory Board, which recommended an outright ban over three years ago. The ban was contested by several drug makers and the matter wound up in courts with the Supreme Court ordering a fresh review by the panel late last year. ‘Irrational’ and ‘unsafe’ The drug review committee deemed these FDC drugs -- which have more than two active ingredients in a single dose -- lacked therapeutic justification and the combinations potentially toxic terming them “irrational” and “unsafe.” According to <a href="https://timesofindia.indiatimes.com/india/govt-bans-popular-painkiller-327-other-unsafe-fixed-dose-drugs/articleshow/65790311.cms">estimates</a> by <keyword id="799945" type="ORGANIZATION" weightage="20" keywordseo="All-India-Drug-Action-Network">All India Drug Action Network</keyword>, one of the petitioners behind the ban, the market for unsafe, problematic FDCs in India makes up a quarter of the total pharma market in India valued at ₹1.3 trillion ($14 billion). In a recent statement it noted that the FDCs under scrutiny account for approximately ₹25 billion in sales and “represent only the tip of the iceberg.” “The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs,” the drug network said in a recent <a href="https://aidanindia.wordpress.com/">statement. </a> Indian drug makers body, The Indian Drug Manufacturers’ Association (IDMA) has <a href="https://www.livemint.com/Politics/6aT2TnCIpzTEO7ZG7cYAkJ/Govt-prohibits-manufacture-supply-sale-of-328-FDC-drugs.html">said </a>it “respects” the verdict as responsible citizens of India, adding it has never advocated “irrational” FDCs but believes in the “advantages of patient convenience and compliance” that these combination drugs provide.

Indian government bans several painkillers, diabetes and antibiotic drugs over safety concerns

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Here’s why the Supreme Court has exempted Saridon from the ban on FDCs

Rimin Dutt

Indian government bans several painkillers, diabetes and antibiotic drugs over safety concerns

Rimin Dutt

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