Government Bans Oral Nimesulide Above 100 mg, Removes Cough Syrups from OTC Sale

The Union Government has banned the manufacture, sale and distribution of all oral formulations of Nimesulide exceeding 100 mg, citing potential risks to human health and the availability of safer alternatives. The decision comes into force with immediate effect, according to a gazette notification issued by the Ministry of Health and Family Welfare.

Legal Basis and Regulatory Process

The prohibition has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB). The notification states that 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.”

The government further noted that the ban is necessary and expedient in public interest, particularly because safer alternative medicines are already available in the market.

About Nimesulide and Health Risks

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly used for the treatment of acute pain and fever. However, it has long been associated with liver toxicity in certain cases, prompting repeated reviews by medical experts.

The ban follows a detailed evaluation by the Indian Council of Medical Research (ICMR), India’s apex health research body, which reviewed the drug’s safety profile in adults and submitted its recommendations to the national drug regulator.

Key ICMR Recommendations (Accepted by Expert Committee)

The expert committee accepted several critical recommendations made by ICMR, including:

• Nimesulide should be used only as a second-line treatment, when other medicines fail or cannot be prescribed

• The drug must not be used by:

  • Pregnant women

  • Lactating women

  • Women planning pregnancy

• Nimesulide should not be prescribed to patients with:

  • Liver impairment

  • Kidney disease

• The drug should not be administered alongside other medicines toxic to the liver or kidneys

• Nimesulide is already banned for children below 12 years of age

Cough Syrups Removed from Over-the-Counter (OTC) List

In a parallel regulatory move, the Health Ministry has also issued a draft notification proposing the removal of cough syrups from Schedule K, which lists medicines exempt from prescription requirements.

Under the proposed change:

• Cough syrups will no longer be sold over the counter

• A valid prescription from a registered medical practitioner will be mandatory

• Lozenges, tablets and pills for cough will continue to remain OTC

Background: Child Deaths Linked to Contaminated Syrups

This move comes in the aftermath of at least 22 children dying in Madhya Pradesh after consuming contaminated cough syrups. Similar incidents were also reported in Rajasthan, where cough syrups not meant for young children were administered.

An expert committee under the drug regulator informed the Drugs Consultative Committee (DCC) that:

“Recent incidences due to contaminated cough syrups warrant deletion of the exemption provided for syrups for cough.”

The draft notification has been opened for public consultation, with all stakeholders invited to submit objections or suggestions within 30 days before final implementation.

Wider Impact: Veterinary Use and Wildlife Safety

Nimesulide has also been flagged for its ecological impact, particularly on vultures. According to the Bombay Natural History Society (BNHS), several cow shelters in Rajasthan and Madhya Pradesh have stopped using veterinary drugs toxic to vultures, including:

• Nimesulide

• Diclofenac

• Aceclofenac

• Ketoprofen

These have been replaced with safer alternatives such as meloxicam and tolfenamic acid, helping stabilise populations of critically endangered vultures.

What the Ban Means for Consumers and Doctors

• Oral Nimesulide formulations above 100 mg are now illegal for human use

• Doctors are expected to shift to safer NSAID alternatives

• Pharmacists must immediately withdraw prohibited formulations

• Cough syrups may soon require mandatory prescriptions