India bans 156 fixed dose combination (FDC) drugs
The central government has banned 156 widely sold fixed-dose combination (FDC) drugs, including antibacterial medicines used for fever, cold, allergies and pain, saying they are “likely to pose risks to humans.” FDC drugs These are medicines that have a combination of two or more active pharmaceutical ingredients in a fixed proportion. These drugs are also known as “cocktail” medicines.
The decision comes after the Drugs Technical Advisory Board (DTAB) and a committee of experts determined that these combinations, including antibacterial drugs, lacked therapeutic justification and posed risks to human health.
According to a gazette notification issued by the Union Health Ministry on August 12, the banned drugs include combinations like ‘aceclofenac tablet 50 mg + paracetamol 125 mg’, mefenamic acid injection + paracetamol, cetirizine hydrochloride + paracetamol + phenylephrine hydrochloride, levocetirizine + phenylephrine hydrochloride + paracetamol, paracetamol + chlorpheniramine maleate + phenylpropanolamine and camillophine dihydrochloride 25 mg + paracetamol 300 mg.
Apart from these, the combination of paracetamol, tramadol, taurine and caffeine was also banned as tramadol is an opioid-based painkiller. The government issued the ban under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to ban the manufacture, sale and distribution of drugs deemed harmful or unnecessary.
The DTAB stressed that no form of regulation or restriction could justify the use of these fixed-dose combinations on patients, leading to the decision to ban them altogether in the interest of public health. The gazette notification read: “The central government is satisfied that the use of the fixed-dose combination drug is likely to involve risks to human beings, whereas safer alternatives to the said drug are available.”
He also said the DTAB also reviewed these FDCs and recommended that “there was no therapeutic justification for the ingredients contained in these FDCs.”
The notification said: “FDC may pose a risk to human beings. Therefore, in the interest of the general public, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26 A of the Drugs and Cosmetics Act, 1940.”
“In view of the above, no regulation or restriction is justified to allow its use in patients. Therefore, only the prohibition provided for in Article 26A is recommended.”
The notice also noted that “the central government is convinced that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution for human use of the said drug in the country.”
The government had announced in 2016 a ban on the manufacture, sale and distribution of 344 drug combinations after a panel of experts, set up at the behest of the Supreme Court, declared that they were being sold to patients without scientific data and the order was challenged by the manufacturers in court.
As of June 2023, 14 FDCs that were part of those 344 drug combinations were banned. Many of the recently banned FDCs were also part of those 344 drug combinations.
(With contributions from PTI)
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