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CDSCO asks State drug regulators to keep vigil against use of nimesulide in animals
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Our Bureau, New Delhi
February 26 , 2025
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The Central Drugs Standard Control Organisation (CDSCO) has directed the state and Union Territory (UT) drug regulators to sensitise its inspectorate staff to keep strict vigil to ensure that the non-steroidal anti-inflammatory drug (NSAID) nimesulide is not manufactured illegally and misused in animals, as the drug has been banned for animal use.
The direction is following a notification by the Union ministry of health on December 30, 2024, banning manufacturing and sale of nimesulide and its formulation for animal use, finding it likely to involve risk to animals.
The veterinary division of the organisation, in a communication to the state and UT drug controllers, requested that in the light of the recent measures, "to sensitize your inspectorate staff to keep strict vigil on manufacture, sale and distribution of drug in the country and take all regulatory measures to ensure that drug is not illegally manufactured/sold and its misuse in the animals is prevented."
The Central drug regulator has also requested the state and UT drug controllers to forward the details of action taken in the matter for further action.
Notifying the ban, the Ministry in December, 2024 said that there are safer alternatives to this drug available in the market, it added.
The drug regulator also noted that the Delhi High Court, in an order on September 1, 2023, related to Gaurav Kumar Bansal vs Union of India directed to furnish the reason as to why the drug nimisulide has not been banned.
It may be noted that the Drugs Technical Advisory Board (DTAB), the expert body that advises the drug regulator on technical matters, in the beginning of 2024, recommended ban on the use of all formulations of the drug for veterinary use, and requested the Indian Council of Medical Research (ICMR) to study the effect of nonsteroidal anti-inflammatory drug (NSAID) nimesulide on adult human beings.
The DTAB observed that in an order of Delhi High Court on September 1, 2023, the Court has directed the Central government to furnish the reason as to why the drug has not been banned, and deliberations were undertaken in this regard.
"DTAB deliberated the matter and agreed to ban on veterinary use of all formulations of nimesulide," said the Board. The recommendation was made while considering a proposal to ban veterinary use of all formulations of the drug for vulture conservation.
"Further it was decided that ICMR may also be requested to study the effect of nimesulide on adult human beings for further course of action in light of the fact that nimesulide drug has been prohibited in children below 12 years of age," it added.
The Board was apprised that Bombay Natural History Society (BNHS) had stated that one of the most important extant risks that the vulture populations in India are still facing is the veterinary use of nimesulide to treat cattle. nimesulide - similar to diclofenac, aceclofenac and ketoprofen - have been found to be toxic to vultures, leading to mortality through visceral gout and renal failure.
The ministry of environment, forest and climate change (MOEF&CC) supported the safety-testing of nimesulide on vultures carried out collaboratively by the BNHS and the Indian Veterinary Research Institute (IVRI). The project found that the vultures treated with nimesulide died by 24 hours post treatment.
Based on this background, alongside recommendation of ban on veterinary use of aceclofenac and ketoprofen, the Board was requested to consider ban on veterinary use of all formulations of nimesulide.
Since nimesulide, aceclofenac and ketoprofen are also used to treat humans, their ban must cover manufacture, distribution, sale, and use of bolus and injectable formulations in doses fit for large animals (vials larger than 3 ml).
This would help in avoiding the possible loophole of relabeling larger vials (used for veterinary purposes) as multi-dose vials for humans, which could then be readily misused. Also, along with the ban, issuing appropriate instructions to the manufacturers of aceclofenac, ketoprofen and nimesulide to destroy existing stock of drugs may be considered, it added.
The ministry of health and family welfare in 2023 banned manufacture, sale and distribution of ketoprofen and aceclofenac and their formulations for animal use with immediate effect, following DTAB's recommendation.
The Board, during the time also recommended formation of a sub-committee to examine the issues related to drugs which can affect animal health or environment and submit a report to it for appropriate action.
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