Tag Archives: Nimesulide

How India tackles adverse drug reactions — by ignoring data

With 10 percent of 3.63 trillion medicines popped worldwide in 2015, India is the world’s third-largest medicine market. It stands to scientific reason that these drugs will have side effects.

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Pharma Frauds: A critical review of the functioning of Central Drugs Standards Control Organisation

The problem of irregularities in drug trials or approval appears to be partly because of the fundamental flaw in the policies of the CDSCO. Unlike its western counterparts, it appears to be totally oriented towards promoting the interests of the drug firms rather than the patients/public.

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Health ministry probing irregularities in drug trials

New Delhi: The health ministry on Thursday said it has “already taken several steps” to plug loopholes in the Central Drugs Standards Control Organization (CDSCO), which has been pulled up by a parliamentary panel for allowing at least 33 drugs to be sold in India without proper trials.

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House panel finds huge irregularities in drug trials

New Delhi: Huge irregularities have surfaced in the functioning of Central Drugs Standards Control Organisation (CDSCO), with a parliamentary panel pointing out that at least 33 drugs have been allowed to be sold in India without proper trials.

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33 new medicines approved without undergoing human trials

New Delhi: A report by the parliamentary standing committee for health and family welfare, which looked at the functioning of the Central Drugs Standard Control Organization (CDSCO), reveals that 33 new medicines were approved by the country’s highest office on drugs between January 2008 and October 2010, without the medicines undergoing human trials.

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DCGI directs manufacturers of Nimesulide to add ‘box warning’

New Delhi: The Drug Controller General of India (DCGI) has asked the manufacturers of Nimesulide to add ‘box warning’ on its label, suggesting that its use to be restricted to 10 days and if longer clinical use is necessary then liver function test should be assessed periodically.

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Madras High Court revokes ban on manufacture and sale of paediatric drugs nimesulide and PPA

Madras High Court has revoked a ban on manufacture and sale of paediatric drugs nimesulide and phenylpropanolamine (PPA). Early this year, the union health ministry had banned sale of anti-inflammatory drug nimesulide for use in children below 12 years of age and decongestant formulation PPA used in cough syrups citing their adverse impacts on human health, including liver toxicity.

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