The center has banned at least 14 fixed combination drugs, including nimesulide and paracetamol dispersible tablets. Clopheniramine maleate and codeine syrup. He said these drugs have no “therapeutic justification” and may pose “risks” to people.
An FDC drug is a drug compounded by combining two or more active pharmaceutical ingredients (APIs) in a certain ratio. (Representative image)
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In a notice issued on Friday, the Union Ministry of Health banned drugs (such as combinations of nimesulide and paracetamol dispersible tablets), including drugs used to treat common infections, coughs and fevers. Clopheniramine maleate and codeine syrup. Forcodine, promethazine, amoxicillin, bromhexine, bromhexine dextromethorphan, ammonium chloride, menthol. Paracetamol, chlorpheniramine, guaifenesin, including bromhexine and phenylephrine. and salbutamol and bromhexine.
The move follows the recommendation of an expert panel that “this FDC (fixed-dose combination drug) has no therapeutic justification and may pose risks to humans.” It is a thing. Therefore, for the greater public interest, the manufacture, sale and distribution of this FDC should be prohibited under section 26A of the Pharmaceuticals and Cosmetics Act of 1940. Not justified for patient use. “
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“And based on the recommendations of the Expert Committee and the Pharmaceutical Technology Advisory Committee, the central government has determined that it is necessary and appropriate in the public interest to regulate by prohibiting manufacture, sale and distribution for sale. Satisfied.”The drug is prohibited for human use in the country,” the notice said.
An FDC drug product is a drug product that contains two or more active pharmaceutical ingredients (APIs) in combination in fixed proportions.
In 2016, the government released 344 combination drugs after an expert panel set up by a Supreme Court order said they were being marketed to patients without scientific data, and the order was challenged. announced a ban on the manufacture, sale and distribution of The manufacturer sued in court. 14 of his FDCs, which are now banned, are part of a combination of these 344 drugs.
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