The government recently banned a number of fixed drug combinations.
Fixed Drug Combinations (FDC):
A fixed-dose combination (FDC) is that which includes two or more active pharmaceutical drugs combined in a single dosage form, which is manufactured and distributed in fixed doses. There is single tablet instead of two or three. Eg. Single tablet will have dual salts for diabetes and blood pressure.
There were arguments in favour of the ban and against it.
Arguments in favor:
1. The rationale behind banning FDCs is the fact that there are some irrational combinations.
2. Combining two drugs is not possible as both of them require opposite mode of action in body. Eg. sulphonylurea (diabetic drug) needs to be given before food and metformin (diabetic drug) after food. This combination which was available in market which makes it becomes difficult for doctor to recommend the drug -before or after food.
3. Unregulated drug market exists in India and number of drugs in different combinations available, which makes it difficult to check if the drugs and their various combinations have indeed been cleared for safety and efficacy.
1. In many everyday multiple drug regimens for different diseases like diabetes and blood pressure the FDC’s managed to achieve excellent results.
2. It improves compliance of patient. Instead of taking 5 different drugs in a day at different times they have to take only two tablets of FDC’s.
3. For a person diagnosed with diabetes, there are multiple risk factors like metabolic disorder, cholesterol, blood pressure, heart disease. So combinations help to a great extent by bringing down the number of drugs that a patient takes.
4. The FDC’s are also cost effective for patients ad they have to take them life long.
5. There was dissatisfaction from a vibrant pharmaceutical industry as it reduces their revenues.
The Way forward:
Instead of blanket ban the Central Drug Standards Control Organisation, should specify inclusion criteria based on clear scientific evidence for FDCs.
All the FDCs that do not fulfill the criteria should be banned.