{"id":484987,"date":"2026-01-01T15:19:23","date_gmt":"2026-01-01T15:19:23","guid":{"rendered":"https:\/\/www.europesays.com\/us\/484987\/"},"modified":"2026-01-01T15:19:23","modified_gmt":"2026-01-01T15:19:23","slug":"health-ministry-bans-nimesulide-oral-tablets-syrups-over-100-mg-removes-cough-syrups-from-otc-sales","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/484987\/","title":{"rendered":"Health Ministry bans nimesulide oral tablets, syrups over 100 mg, removes cough syrups from OTC sales"},"content":{"rendered":"

The government has banned the manufacture, sale and distribution of nimesulide, a common pain and fever medication, in all oral \u201cimmediate release\u201d formulations above the dosage of 100 mg, saying it poses a health risk.<\/p>\n

In a notification, the Ministry of Health and Family Welfare said the Central government is \u201csatisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available\u201d. It said it is \u201cnecessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use.\u201d The notification specifically listed, \u201cAll oral formulations containing Nimesulide above 100 mg in immediate-release dosage form.\u201d<\/p>\n

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Simultaneously, the Ministry also released a draft notification removing cough syrups from the list of over-the-counter medicines.<\/p>\n

It removes \u201csyrups \u2026 for cough\u201d from Schedule K, the list of medicines exempted from the requirement of a prescription by a registered medical practitioner. Lozenges, pills or tablets for cough continue to remain on the list.<\/p>\n

This comes in the wake of at least 22 children dying in Madhya Pradesh after consuming contaminated cough syrups. There have also been instances, including one in Rajasthan, where children given cough syrups not meant for them have died.<\/p>\n

Earlier this year, an expert committee under the drug regulator said \u201cDCC was apprised about the recent incidences due to contaminated cough syrup and it was proposed that the exemption provided\u2026 in respect of syrups for cough may be deleted.\u201d<\/p>\n

All stakeholders have been asked to submit their suggestions or objections over the next 30 days, after which the draft would be considered for implementation.<\/p>\n

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The banning of certain formulations of nimesulide was one of the recommendations made by the Indian Council of Medical Research after reviewing the effect of nimesulide on adults. This recommendation, along with other advice on prescribing the medicine, were accepted by an expert committee under the apex drug regulator. Nimesulide is known to cause liver toxicity in some cases.<\/p>\n

The other recommendations by ICMR, which were accepted by the committee, included one that said that the drug be used only as a second line of treatment when other drugs fail to work or cannot be prescribed. The ICMR also recommended that the drug not be used in pregnant, lactating women and those planning for pregnancy.<\/p>\n

It also recommended that nimesulide should not be prescribed to patients with kidney or liver impairment. It should also not be administered alongside other drugs that can be toxic to the liver or the kidneys. The drug is already banned for children under the age of 12.<\/p>\n

The committee also asked ICMR to review the impact of the use of the drug by different ages \u2013 children below the age of 12, those between 12 and 18 years, and those above the age of 60.<\/p>\n

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\"Anonna<\/p>\n

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Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government\u2019s management of the Covid-19 pandemic and closely followed the vaccination programme.
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\nHer stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports.
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\nDutt also takes a keen interest in the country\u2019s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan.
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\nShe was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University\u2019s Dart Centre. Dutt has a Bachelor\u2019s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times.
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\nWhen not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. … Read More <\/a>\n <\/p>\n

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\u00a9 The Indian Express Pvt Ltd<\/p>\n

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