Centre bans 156 fixed-dose combination drugs used for fever, pain, allergies
New Delhi, Aug 22: The government has banned 156 widely sold fixed-dose combination (FDC) drugs including antibacterial medicines used for fever, cold, allergies and pain, saying that they are "likely to involve risk to human beings".
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as "cocktail" drugs.
According to a gazette notification issued by the Union health ministry on August 12, the government has banned 'Aceclofenac 50mg + Paracetamol 125mg tablet', one of the popular combinations used as pain-relieving medicines manufactured by top pharma companies.
The list also includes Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg.
The Centre also banned the combination of Paracetamol, Tramadol, Taurine and Caffeine. Tramadol is an opioid-based pain killer.
"The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available," the notification said.
It said that the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational".
It further stated that the apex panel Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that "there is no therapeutic justification for the ingredients contained in these FDCs".
"The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940," the notification read.
"In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended," it added.
Following the DTAB's recommendations, the notification said that "the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country".
The list includes certain products which were already discontinued by many drug makers.
The government in 2016 had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court, had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court, sources said.
In June 2023, 14 FDCs which were part of those 344 drug combinations, were banned. Many of the FDCs banned recently were also from those 344 drug combinations, the sources said.
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Austrian police detain suspect in case of rat poison found in baby food jars on supermarket shelves
Vienna (AP): Police in eastern Austria say a 39-year-old suspect has been arrested after rat poison turned up in some HiPP baby food jars on supermarket shelves in central Europe.
HiPP, which recalled some of its baby food jars in Austria, Slovakia and the Czech Republic after the case came to light last month, said in a statement Saturday it was “greatly relieved” by the arrest, and would provide further updates as verified details come in.
The Burgenland State Criminal Police Office, under the direction of prosecutors, said a probe was launched after poison turned up in a baby food jar purchased at a supermarket in the city of Eisenstadt on April 18.
It said the suspect was being questioned, and that no further details would be immediately provided. The Burgenland public prosecutor's office has announced an investigation into suspected “intentional endangerment of the public.”
The Austrian Press Agency reported that an expert report on the toxicity of the poison was pending. A total of five tampered baby food jars were seized before they could be consumed, APA reported.
Authorities said previously they believe the tampering occurred in 190-gram (6.7-ounce) jars of baby food made with carrots and potatoes for 5-month-olds that were sold from SPAR supermarkets in Austria.
HiPP responded by recalling all of its baby food jars sold at SPAR supermarkets — which include SPAR, EUROSPAR, INTERSPAR and Maximarkt stores — in Austria as a precaution. Vendors in Slovakia and the Czech Republic also removed all of the brand's baby jars from sale.
The company said the recall was not due to any product or quality defect on its part, and said the jars left its facility in “perfect condition.”
Police said a customer at the time of the discovery had reported that a jar appeared to have been tampered with, but no one had consumed the baby food.
