Oral: Because of safety concerns dosages of mesulide over 100 mg are prohibited

Oral: Because of safety concerns dosages of mesulide over 100 mg are prohibitedOral: Because of safety concerns dosages of mesulide over 100 mg are prohibited: Citing health dangers, the Center has prohibited the production, distribution, and sale of any oral formulations containing more than 100 mg of the painkiller nimesulide in immediate-release dose form.

Following the Indian Council of Medical Research’s (ICMR) advice and public consultation with the Drugs Technical Advisory Board (DTAB), the Union Health Ministry made the decision. Section 26A of the Drugs and Cosmetics Act of 1940 has imposed the ban, which goes into force right away.

The warning released on Monday said, “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 humans and that safer alternatives to the said drug are available.”

“Therefore, after consulting with the Drugs Technical Advisory Board and using the authority granted by section 26A of the Drugs and Cosmetics Act, 1940, the Center hereby forbids the production, distribution, and sale of the drug, effective immediately,” it said. A non-steroidal anti-inflammatory medication used to treat pain and fever, mesulide has come under fire for potentially harming the liver.

Safety is tightened, officials claimed. It was prohibited for minors in 2011. Although Canada, Japan, the US, Australia, and the UK had never before authorized it, the European Medicines Agency concluded in 2007 that the risks exceeded the benefits.

Order in effect right now

The choice was made after consulting with DTAB and following the ICMR’s suggestion.

Section 26A of the Drugs and Cosmetics Act of 1940 has imposed the ban, which goes into force right away.

Authorities claim the prohibition increases security.