The Center has banned 14 fixed-dose combination drugs (FDCs) in the country saying there is “no therapeutic justification” for these medicines and they may pose “risks” for people. FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The move came following recommendations from an expert committee. The Ministry of Health has also issued a notice on the matter.
The Center has banned 14 fixed-dose combination drugs (FDCs) in the country saying there is “no therapeutic justification” for these medicines and they may pose “risks” for people. FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The move came following recommendations from an expert committee. The Ministry of Health has also issued a notice on the matter.
These 14 fixed-dose combination drugs include Nimesulide and acetaminophen dispersible tablets and clopheniramine maleate and codeine syrup. FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
These 14 fixed-dose combination drugs include Nimesulide and acetaminophen dispersible tablets and clopheniramine maleate and codeine syrup. FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
These banned drugs included those used for treating common infections, cough and fever combinations such as: Nimesulide Paracetamol dispersible tablets, Chlopheniramine Maleate Codeine Syrup, Pholcodine Promethazine, Amoxicillin Bromhexine and Bromhexine Dextromethorphan Ammonium Chloride Menthol, Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin and Salbutamol Bromhexine.
These banned drugs included those used for treating common infections, cough and fever combinations such as: Nimesulide Paracetamol dispersible tablets, Chlopheniramine Maleate Codeine Syrup, Pholcodine Promethazine, Amoxicillin Bromhexine and Bromhexine Dextromethorphan Ammonium Chloride Menthol, Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin and Salbutamol Bromhexine.
The expert committee stated that “there is no therapeutic justification for this FDC (fixed dose combination) and FDC may pose risks to humans. Therefore, in the broader public interest, it is necessary to ban the production, sale or the distribution of this FDC pursuant to section 26A of the Drugs and Cosmetics Act, 1940. In view of the above, any type of regulation or restriction to permit any use in patients is not justifiable.
The expert committee stated that “there is no therapeutic justification for this FDC (fixed dose combination) and FDC may pose risks to humans. Therefore, in the broader public interest, it is necessary to ban the production, sale or the distribution of this FDC pursuant to section 26A of the Drugs and Cosmetics Act, 1940. In view of the above, any type of regulation or restriction to permit any use in patients is not justifiable.
As per the notice issued by the Ministry of Health, “And considering that, based on the recommendations of the Committee of Experts and the Technical Advisory Council on Drugs, the Central Government believes that it is necessary and expedient in the public interest to regulate by banning the production for sale, sale and distribution for human use of the aforementioned drug in the country,” the notification reads.
As per the notice issued by the Ministry of Health, “And considering that, based on the recommendations of the Committee of Experts and the Technical Advisory Council on Drugs, the Central Government believes that it is necessary and expedient in the public interest to regulate by banning the production for sale, sale and distribution for human use of the aforementioned drug in the country,” the notification reads.
In early 2016, the government announced a ban on the manufacture, sale and distribution of 344 drug combinations after a panel set up by the Supreme Court said they were being sold to patients without scientific data and the order had been challenged by the manufacturers in court. The currently 14 banned FDCs are also part of those 344 drug combinations.
In early 2016, the government announced a ban on the manufacture, sale and distribution of 344 drug combinations after a panel set up by the Supreme Court said they were being sold to patients without scientific data and the order had been challenged by the manufacturers in court. The currently 14 banned FDCs are also part of those 344 drug combinations.
#government #bans #fixeddose #combination #drugs #citing #health #risks #Full #list