Health Ministry bans nimesulide oral tablets, syrups over 100 mg, removes cough syrups from OTC sales

This comes in the wake of at least 22 children dying in Madhya Pradesh after consuming contaminated cough syrups

The Union Health Ministry has banned the manufacture, sale and distribution of the common pain and fever medication nimesulide in all oral “immediate release” formulations above the dosage of 100 mg. The gazette notification says, “…the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use.”

Simultaneously, the health ministry has also released a draft notification, removing cough syrups from the list of over-the-counter medicines. The notification removes “syrups … for cough” 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.

All stakeholders have been asked to submit their suggestions or objections over the next thirty days, after which the draft would be considered for implementation.

The Indian Council of Medical Research (ICMR) made the recommendation on nimesulide after reviewing its effect 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.

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. ICMR also recommended that the drug not be used in pregnant, lactating and women planning for pregnancy. The ICMR further 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 years.