Health Ministry proposes to remove syrups as OTC medicine, ban Nimesulide

New Delhi: Months after adulterated cough syrup deaths of children were reported from Madhya Pradesh, the Union Health Ministry has proposed removing cough syrups as an over-the-counter medicine while announcing a ban on the production, marketing and sale of a high dose of oral Nimesulide, a common pain killer, because of safety concerns.

In a draft notification, the ministry has suggested amending the Drug Rules, 1945 to remove cough “syrups” as a class of medical products, exempted from sale-licensing rules that allow general stores to sell such products.

The list currently includes syrups, lozenges, pills and tablets for cough along with other items like pain balm, antacid, cotton wool, bandage, gripe water for infants, skin ointment, burn ointment, tincture iodine and Mercurochrome bottles not exceeding 100 ml.

Issued on Dec 29, the notification to modify Schedule K of the rules will be open for public comments for 30 days.

The move comes a few months after at least 20 children from Chhindwara district in Madhya Pradesh reportedly died after consuming cough syrups adulterated with toxic chemicals.

The Madhya Pradesh incident was not the first such tragedy as multiple instances of spiked cough syrups killing children have been reported in India since 1972.

The World Health Organisation too issued a global alert in 2023 after adulterated cough syrups manufactured in India reportedly triggered children’s deaths in other countries.

The ban on 100 mg of oral Nimesulide in immediate release dosage comes a year after the Indian Council Medical Research recommended such a ban because of the medicine’s safety concerns, which was accepted by the Drug Technical Advisory Board in April 2025.

"The Central government is satisfied 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," the notification issued on Monday said.

Health Ministry sources said only oral formulations above 100 mg in immediate release form are banned. Strengths below 100 mg or strengths above 100 mg in other types of release (like sustained release and extended release) are not under this ban. Also non-oral formulations like topical gels/creams or suppositories are not banned.

Safety concerns on Nimesulide have emerged over its adverse effects, particularly liver toxicity leading to regulatory scrutiny and action in various countries.

The European Medicines Agency restricted the drug’s use in 2002 to adults only, and since then many countries have imposed bans or strict usage guidelines for both human and veterinary applications.

In India, the Central Drugs Standard Control Organisation banned the use of Nimesulide in children below 12 years in 2011 following reports of severe liver damage. Also it is banned in all veterinary products since the medicine turned out to be a killer one for vultures.

Recent concerns have been raised regarding its continued use in adult populations, especially in high-risk groups, prompting a review by the DTAB.

After the review, the ICMR recommended that all formulations of Nimesulide above 100 mg should be banned and CDSCO should ask the manufacturers to place a black box warning on the Nimesulide labels for all medicines that contain the drug either as a single ingredient or in combination. Also it must not be prescribed to patients below 18 years and above 60 years of age.