Health ministry bans use of ketoprofen and aceclofenac for animal use

The Union health ministry has issued a notification prohibiting the manufacture, sale and distribution of pain killers, ketoprofen and aceclofenac and their formulations for animal use with immediate effect, as they are likely to involve risk to animals.

In a gazette notification dated July 31, the Ministry said that the Central Government is satisfied that the use of drug formulations containing ketoprofen and aceclofenac are likely to involve risk to animals and there are safer alternatives of these drugs available in the market.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation, while aceclofenac is a NSAID comparable to diclofenac.

The Ministry noted that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of these formulations for animal use.

The Drugs Technical Advisory Board (DTAB) in its meeting held on May 10, 2023 had recommended to the government to prohibit production and manufacturing of drugs ketoprofen and aceclofenac for animal use. It has also recommended the constitution of a sub-committee to examine the issues related to drugs which can affect animal health or environment and submit a report to the Board for appropriate action.

While considering a representation requesting for ban on these two drugs for treatment of livestock animals to conserve vultures, the Board opined “that the issue should proactively examined and a list of all such drugs which affect the animal health or environment should be prepared for taking further appropriate action in the matter and accordingly recommended to constitute a sub-committee to examine the matter in details and submit its report to the Board.”

In the representation, it was mentioned that ketoprofen and aceclofenac in cattle is equally toxic as diclofenac and can kill vultures. A study also showed that the aceclofenac was rapidly metabolised into diclofenac and ketoprofen is toxic to gyps vultures.

The matter was referred to the Department of Animal Husbandry and Dairying (DAHD), under the ministry of agriculture and farmers’ welfare for expert opinion. It was examined by the DAHD in consultation with the subject experts and it was recommended to impose a ban on the veterinary drugs “ketoprofen and aceclofenac” for treatment of livestock animals to conserve vulture.

DTAB deliberated the matter and agreed to prohibit the manufacture, sale and distribution of the drugs ketoprofen and its formulations and aceclofenac and its formulations for animal use.

It may be noted that almost one and a half decade back, the drug regulator has banned the use of diclofenac in veterinary medication, as it has identified that the drug is a threat to the existence of some of the species of vultures. According to a study, some of the other NSAIDs such as aceclofenac will also have the same impact on vultures. For instance, aceclofenac metabolises into diclofenac in some mammal species and poses the same risk to vultures as administering diclofenac to the livestock.

A study conducted by the researchers from Indian Veterinary Research Institute, Uttar Pradesh, and others and published in 2022, said that aceclofenac is vulture-toxic and behaves similar to diclofenac in domestic water buffalo as well as in domestic cattle, posing the same risk to vultures. It recommended immediate ban on the veterinary use of the drug across vulture-range countries.

The use of diclofenac, which was used mainly to treat injured and dying cattle has resulted in population decline of three species of Gyps Vultures in the country and other South Asian nations from the mid-1990s, it said. When the vultures feed on the dead bodies of animals that had been treated with the drug, it results in kidney failure, visceral gout and death of these birds. It added that NSAIDs such as meloxicam and tolfenamic acid are identified as drugs that are safe to vultures. However, other NSAIDS such as ketoprofen, nimesulide, carprofen, and flunixin among others have been proven as toxic to captive vultures, it added.

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