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The Central drug regulator may look at widening its scrutiny over the use of nonsteroidal anti-inflammatory drug (NSAID) nimesulide on adult human beings, especially restricting its use as a second line drug and prohibiting its use in immediate release dosage forms above 100 mg.
The Drugs Technical Advisory Board (DTAB), the expert body that advises the drug regulator on technical matters, has agreed to various recommendations in a report submitted by the Indian Council of Medical Research (ICMR).
"Nimesulide should be used only as a second line drug, only after exhausting first line options," said the Board after its latest meeting, agreeing with the recommendation in the ICMR report.
It also agreed with the ICMR recommendations that the drug should not be used in pregnant, lactating women and women planning for pregnancy, and patients with renal and hepatic impairment. It should also not be co-administered with other hepatotoxic and renal toxic drugs.
"All oral formulations of nimesulide above 100 mg in immediate release dosage form should be prohibited," added DTAB, agreeing with the ICMR recommendations.
The Board, which has earlier requested ICMR to submit a report on the effects of nimesulide on adult human beings, in the light of its prohibition in children below 12 years of age, has now requested the Council to conduct further review on the matter in a systemic manner.
It opined that nimesulide is one of the effective drugs to reduce fever and used for short term treatment.
"After detailed deliberation, DTAB recommended that ICMR may be requested to conduct the systemic review for use of nimesulide drug below 12 years of age, 12 to 18 years of age as well as 60 years of age and above for further deliberation," said a minutes of the Board meeting.
It may be noted that the drug regulator has banned the use of all formulations of the drug for veterinary use, following an earlier recommendation of DTAB.
The DTAB, while considering the proposal to ban the drug for animal use, earlier observed that in an order of Delhi High Court on September 1, 2023, the Court 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.
"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 health and family welfare has last year banned manufacture, sale and distribution of ketoprofen and aceclofenac and their formulations for animal use with immediate effect, following DTAB's recommendation.
The Board also during the time noted that 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.
It was 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.
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