New Delhi: The government has decided to ban 156 fixed-dose combination (FDCs) medicines, including antibiotics, painkillers, and multivitamins, after a review found that they posed health risks.
In a gazette notice issued on August 21, the Ministry of Health announced that the manufacturing, marketing, and distribution of these medications are now prohibited due to their associated health risks.
The notification states that the banned FDCs include antibiotics, anti-allergic medications, pain relievers, multivitamins, and combination treatments for fever and hypertension.
Fixed-dose combination (FDC) drugs are treatments that include a specific ratio of two or more active pharmaceutical ingredients and are commonly referred to as cocktail drugs.
On August 12, the Union Health Ministry issued a gazette notification announcing the ban of the 'Aceclofenac 50mg + Paracetamol 125mg tablet', a commonly used pain reliever from leading pharmaceutical companies
The list of banned medications 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 300 mg.
The Centre has also prohibited the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol, an opioid-based painkiller, is among the ingredients in this banned mixture.
"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
The issue was reviewed by an Expert Committee appointed by the Centre, which deemed these FDCs as irrational. The notification stated, "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."
"Because 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," the statement added.
The ministry added that two committees — including one under the Central Drugs Standard Control Organisation’s (CDSCO) Drugs Technical Advisory Board (DTAB) — examined the FDCs and found that “there is no therapeutic justification for the ingredients contained” in the combination drug while they may involve “risk to humans”.
Based on the DTAB's recommendations, the notification noted 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."
Input from various sources
Rehash/Simran Sethi/MSM