Government Bans 156 Fixed-Dose Combination (FDC) Drugs for Health Risks

The central government has announced a ban on 156 widely-used fixed-dose combination (FDC) drugs, including several commonly prescribed antibacterial and pain-relief medications. This decision follows concerns that these drugs pose significant risks to human health.

Drugs Affected:

The ban includes popular FDCs such as 'Aceclofenac 50mg + Paracetamol 125mg tablets,' which are frequently used for pain relief. Other banned combinations include Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, and several others.

Reason for Ban:

According to the Union Health Ministry's gazette notification dated August 12, the ban is based on recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). These panels concluded that these FDCs lacked therapeutic justification and could be harmful.

Specific Concerns: The banned list also includes combinations of paracetamol with tramadol, taurine, and caffeine, which were found to have potential health risks.

Legal Basis:

The ban is issued under Section 26A of the Drugs and Cosmetics Act, 1940, which authorizes the government to prohibit drugs that are deemed harmful or unnecessary.

Public Health: The DTAB highlighted that no regulatory measures could justify the continued use of these FDCs, leading to a complete prohibition to safeguard public health.

Impact and Alternatives:

Availability: The banned drugs will no longer be manufactured, sold, or distributed.

Alternatives: Safer alternatives to these FDCs are available and will be recommended for use in place of the banned combinations.