Why Did Government Ban Over 300 Fixed Dose Combination Drugs?

Why Did Government Ban Over 300 Fixed Dose Combination Drugs?

The Health Ministry of India recently banned 344 Fixed Dose Combinations which include several common cough syrup solutions, painkillers and antibiotic combinations, many of which are sold over the counter.

What Is A Fixed Dose Combination (FDC) ?

Fixed dose combinations (FDCs) is a combination of two or more active drugs in a single dosage form used for a particular health condition(s).

How Is Fixed Dose Combination (FDC) Approved For Marketing?

A particular Fixed dose combination is approved on the basis of following considerations:

-A valid therapeutic justification or value addition of a particular combination.

-Clinical Trials of the fixed dose combinations drug with reference treatment are necessary.

What Is The Risk With A Fixed Dose Combination (FDC) ?

Sometimes, taking Fixed dose combination (FDC) may not be beneficial for the patients. Reasons include:

-It can add to the cost of the medicine.

-The patient may have more chances of side-effects

-Dosage alteration of one drug may not be possible without altering the other drug.

-There may be increased chances of drug-drug interactions.

Why Has The Government Banned Many Fixed Dose Combinations (FDC) Drugs?

A large percentage of the Fixed dose combinations being introduced in India are usually irrational whose therapeutic justification is not defined. These irrational FDC increase cost and expose patients to unnecessary side-effects. the Government is convinced that there are enough single drug medicines that are safe and effective.

Are All FDC Drugs Dangerous?

No, all FDC drugs are not dangerous.Most of the FDC drugs are made so that a patient can take benefit from the added effects of the two or more active drugs given in a single dosage form. Some other benefits include:

-Simple dosage schedule improves patient compliance (instead of taking two or more different medicines, patient can take one medicine with two or more active drugs)

-Lower costs of manufacturing compared to the costs of producing separate products.