Full List Of 156 Fixed-Dose Combination Drugs Banned By The Government

The Health Ministry has banned 156 fixed-dose combination (FDC) medicines, including commonly used antibiotics, painkillers, and multivitamins. A gazette notice issued on August 21 announced the prohibition of these drugs due to associated health risks. The production, marketing, and distribution of these FDCs are now prohibited.

Fixed-dose combination (FDC) drugs contain a specific ratio of two or more active pharmaceutical ingredients. These are often referred to as cocktail drugs. On August 12, the Union Health Ministry banned the 'Aceclofenac 50mg + Paracetamol 125mg tablet', a widely used pain reliever from leading pharmaceutical companies.

Combination Treatments for Fever and Hypertension

The notification lists various banned FDCs, including antibiotics, anti-allergic medications, pain relievers, multivitamins, and combination treatments for fever and hypertension. The list 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 banned the combination of Paracetamol, Tramadol, Taurine, and Caffeine. Tramadol is an opioid-based painkiller included in this 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," stated the notification.

Expert Committee Review

An Expert Committee appointed by the Centre reviewed these FDCs and deemed them irrational. The notification mentioned that "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."

"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," added the statement. Based on recommendations from the DTAB (Drugs Technical Advisory Board), 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."

This move aims to safeguard public health by eliminating potentially harmful combinations from circulation. The decision underscores a commitment to ensuring safer alternatives are available for medical treatments.