Government Bans 14 Fixed-Dose Combination Drugs

The government has recently imposed a ban on 14 fixed-dose combinations (FDC) drugs in the country due to a lack of "therapeutic justification" and potential risks to the public. FDC drugs are formulations that combine two or more active pharmaceutical ingredients (APIs) in fixed proportions. This decision was made based on recommendations from an expert committee and has been officially notified by the Health Ministry.

Caution: The Following Drug Combinations are Banned

Among the 14 banned FDC drugs are:

• Nimesulide + Paracetamol dispersible tablets
• Chlorpheniramine Maleate + Codeine Syrup
• Pholcodine + Promethazine
• Amoxicillin + Bromhexine
• Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
• Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
• Salbutamol + Bromhexine

Nimesulide and Paracetamol dispersible tablets, as well as Chlorpheniramine Maleate and Codeine syrup. These FDC drugs are commonly used to treat various ailments, including common infections, cough, and fever.

The expert committee emphasized the absence of valid therapeutic justification for these FDCs and highlighted potential risks to human health. As a result, the government found it necessary to prohibit their manufacture, sale, or distribution under section 26A of the Drugs and Cosmetics Act of 1940. The committee concluded that any regulatory measures or allowances for patient use are not justifiable.

The Health Ministry's notification further confirms that the Central Government, based on recommendations from the Expert Committee and the Drugs Technical Advisory Board, deems it necessary and expedient to regulate and prohibit the manufacture, sale, and distribution of these drugs for human use in the country.

This recent ban is reminiscent of a previous action taken in 2016 when the government prohibited 344 drug combinations. The decision was made after an expert panel, initiated by the Supreme Court, raised concerns about these combinations being sold to patients without sufficient scientific data. The manufacturers contested the order in court, and the current list of 14 banned FDCs is part of those 344 combinations (1^✔ ✔Trusted Source
Crippled Pharmacovigilance: A Qualm of Medical Profession!

Go to source).

Factors that can Influence a Drug Ban

Following factors can influence a drug ban

1. Adverse Effects caused by the drug
2. Availability of safer alternatives
3. Harmful interactions between the drug and other medications or substances
4. Irrational use of drugs, including illicit drugs
5. Harmful interactions with other drugs
6. Failure of risk management

To conclude, it is essential to be mindful of banned combinations and exercise caution when purchasing drugs from the pharmacy.

Reference:

1. Crippled Pharmacovigilance: A Qualm of Medical Profession! - (https://www.jcdr.net/article_fulltext.asp?id=349#)

Source-Medindia