The central government has banned 156 widely sold fixed-dose combination drugs (FDCs) used to treat fever, pain, cold and allergies, citing “potential danger to humans.”
FDC medicines are medicines that contain two or more active pharmaceutical ingredients combined in a set ratio and are also known as “cocktail” medicines.
The decision was taken after a committee of experts and the apex body, the Drugs and Technical Advisory Board (DTAB), found that these combinations, which include antibiotics, have no therapeutic justification and pose a risk to human health.
According to a gazette notification issued by the Union Ministry of Health on August 12, the banned drugs include common combinations such as “aceclofenac 50 mg + paracetamol 125 mg tablet”, mefenamic acid + paracetamol injection, cetirizine HCl + paracetamol + phenylephrine HCl, levocetirizine + phenylephrine HCl + paracetamol, paracetamol + chlorpheniramine maleate + phenylpropanolamine, and camilofine dihydrochloride 25 mg + paracetamol 300 mg.
Additionally, because tramadol is an opioid painkiller, the concomitant use of paracetamol, tramadol, taurine and caffeine was also prohibited.
The ban was issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to prohibit the manufacture, sale or distribution of drugs deemed harmful or unnecessary. The DTAB emphasised that no regulation or restriction can justify the use of these FDCs on patients and decided on a total ban in the interest of public health.
“The central government is of the opinion that the use of this fixed-dose combination drug may be hazardous to the human body but safer alternatives to the drug exist,” the notification said.
The matter was investigated by an expert committee appointed by the central government, which found these FDCs to be “unreasonable”, it said.
It further states that the DTAB has also investigated these FDCs and recommended that “the ingredients contained in these FDCs have no therapeutic justification.”
“FDCs are potentially hazardous to human health. Hence, in larger public interest, it is necessary to prohibit the manufacture, sale and distribution of these FDCs under Section 26-A of the Drugs and Cosmetics Act, 1940,” the notice said.
“In view of the above, any kind of regulation or restriction on its permitted use in patients is not justified. Hence, only a ban under Section 26A is recommended,” it added.
Following the DTAB recommendation, the notification said, “The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the drug for human use in the country.”
The list also includes certain products that have already been discontinued by many pharmaceutical companies.
In 2016, the central government banned 344 drug combinations that an expert committee found were being marketed without scientific data. The ban was challenged in court by drug companies, but the DTAB subsequently recommended that 328 of the combinations were “unreasonable” and should be banned.
Last June, 14 FDCs were banned from the original list, and many of the more recently banned drugs were also included on the original list.
(With inputs from PTI)
