India has officially banned the use of nimesulide, a commonly prescribed painkiller, following research that revealed its harmful effects on vultures, an endangered species critical to the ecosystem. Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) used globally to manage pain and inflammation, has been found to negatively impact both wildlife and humans.

The Central Drugs Standard Control Organisation (CDSCO), India’s primary drug regulatory authority, announced the ban through a gazette notification. The decision, made under Section 26A of the Drugs and Cosmetics Act, 1940, was taken after consulting the Drugs Technical Advisory Board and the central government. The notification prohibits the manufacture, sale, and distribution of all drug formulations containing nimesulide, citing risks to animals. The CDSCO has encouraged the use of safer alternatives, such as meloxicam and tolfenamic acid, which are readily available and less harmful.

Research conducted by the Indian Veterinary Research Institute (IVRI) demonstrated the drug’s toxicity to vultures. During experiments, Gypsy vultures were administered small doses of nimesulide, leading to severe kidney damage and death. The study found that nimesulide exposure was a major contributor to declining vulture populations, as the drug entered their systems through livestock carcasses treated with it. Symptoms included elevated uric acid levels, a clear indicator of kidney failure, with vultures succumbing to its effects within days.

Nimesulide, which targets specific enzymes like COX-2, is commonly used for pain relief and inflammation in animals such as cattle, pigs, and horses. It is also used in veterinary treatment for conditions like osteoarthritis in dogs. However, the drug has significant side effects, particularly in animals with pre-existing liver, kidney, or blood pressure issues. In India, post-mortem examinations of dead vultures linked the cause of death to nimesulide toxicity, with signs such as visceral gout confirming its harmful impact.

Similar concerns led to the earlier ban of diclofenac, another NSAID, in India, Nepal, and Pakistan in 2006, followed by Bangladesh in 2010. Diclofenac caused kidney failure and organ damage in vultures exposed to contaminated livestock remains. These bans have contributed to slowing the decline of vulture populations, particularly in Nepal, where some recovery has been observed.

Experiments conducted in Haryana involved Himalayan griffon vultures exposed to nimesulide. In the study, two vultures were treated with the drug, while two others were given saline as a control. The treated birds showed immediate health deterioration, including kidney failure, and both died within two days. Researchers noted that the effects mirrored those of other toxic NSAIDs like diclofenac and ketoprofen.

Dr. Abhijeet Pawde, who led the research in 2023-24, emphasized the urgency of replacing such harmful drugs to protect vultures from extinction. He stressed that the study’s findings underscore the lethal risks of nimesulide when scavengers consume contaminated carcasses. Another researcher, Dr. M. Karikalan, echoed the need for safer substitutes, calling the transition both practical and necessary.

While the government’s decision marks a crucial step toward wildlife conservation, enforcement challenges persist, particularly in rural areas where nimesulide remains accessible. Veterinary experts have called for stronger measures to ensure compliance and minimize the availability of harmful drugs in the market.

Nimesulide has faced scrutiny globally, with several countries banning its pediatric use due to safety concerns. Formulations designed for veterinary use often contain impurities that can increase toxicity compared to those for humans. Experts have recommended meloxicam and tolfenamic acid as safer and effective alternatives for managing pain and inflammation in animals.

The government also banned fixed-dose combinations of nimesulide and paracetamol for human use in June, citing insufficient therapeutic value and potential health risks. The decision followed recommendations from an expert committee that highlighted dangers associated with such drug combinations, which included medications for common ailments like fever and cough.

Future research aims to assess the toxicity of other widely used drugs, including paracetamol, to protect vultures and other scavenger species essential for maintaining ecological balance. By eliminating the use of harmful drugs and prioritizing safer alternatives, India continues to take significant strides in preserving its biodiversity.

References:

1. Mathesh, Karikalan, Kesavan Manickam, John W. Mallord, K. Mahendran, Asok Kumar M., Debasish Saikia, Chandra Mohan S., et al. “Experimental Safety Testing Confirms That the NSAID NIMESULIDE Is Toxic to Gyps Vultures in India.” Environmental Toxicology and Pharmacology 103 (October 2023): 104284. https://doi.org/10.1016/j.etap.2023.104284.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)