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The STATE Food and Drug Administration (FDA) has prohibited the sale of Crocin Quik,the fast-acting version of Crocin.Manufactured by GlaxoSmithKline,Crocin Quik was promoted as Indias fastest acting paracetemol because it dissolves in the body atleast twice as fast as regular Crocin.However,according to Indian pharmacoepia,paracetamol is not supposed to be coated.Bur Crocin Quik has coating of high sodium bicarbonate content to make it dissolve quicker.Acase of misbranding has been registered under Section17(a) of the Drugs and Cosmetics Act, which states"A drug shall be deemed to be misbranded if it is so coloured,coated and powdered
".The FDA also raised the issue of safety.The company isssues a warning on the packet that says a person on a low sodium diet should consult a doctor."Hoewever ,consumer safety may be compromised since the drug is sold over-the-counter," said FDA Commissioner M.Ramesh Kumar.The sodium bicarbonate content (600mg) in Crocin Quik in fact, exceeds the paracetamol content by 100 mg."It could adversely affect a blood pressure patient." added Kumar .This is the second time Crocin Quik has run into trouble.Its sale is prohibited in Gujarat since September after the FDA there said the product did not meet accepted standards of drug dissolution for paracetamol and it had a prohibitve colouring agent ,titanium dioxide .But the company believes it is merely a labelling issue, not a case of misbranding or safety."The formulation has been proven for its safety and efficacy,and is currently available in over 70 countries," |
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| Posted : 12/10/2005 |
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