Fixed Dose Combinations (FDCs):
Fixed Dose Combinations are refer to the products which contains two or more active ingredients used in single finished formulation for a particular indication (s).
Few examples of Fixed Dose Combinations are as follow:
- Cefixime 200 mg with Azithromycin 250 mg tablet
- Aceclofenac 100 mg , Paracetamol 325 mg with Rabeprazole 20 mg
- Azithromycin 250 mg with Levofloxacin 500 mg
- Nimuslide with Paracetamol
- Amoxyxillin with dicloxacillin
- Cefpodoxime with levofloxacin
When did Fixed Dose Combinations come in limelight?
In march 2016, health ministry took the step to ban 344 fixed dose combinations in India and were planning to ban more fdc’s in future which were claimed to be not approved by Drug controller general of India (DCGI). After ban, pharmaceutical companies knock the high court door for removing ban from these combinations. Lot of petition were filed by pharmaceutical companies to cancel government decision. After many hearing Delhi High Court reverse the government decision on ban of FDC’s in December 2016.
After Delhi high Court order, Government has move to Supreme Court for challenging Delhi High Court order. At time of article written, any final decision is pending.
Related Article: Ban of more than 344 Fixed Dose Combinations by Government. Who is responsible for unapproved combinations manufacturing in India?
Let Know more about Fixed Dose Combinations:
FDC’s can be divided into four groups according to data required for approval for marketing and manufacturing in India.
1) Fixed Dose combinations which has one or more of its active ingredients that fall under new drugs. These combination requires similar data submissions that required for new drug approvals.
2) Fixed Dose Combinations which has all active ingredients that are already approved for marketing and manufacturing individually in India but first time as combination for a particular claim.
3) Fixed Dose Combinations which have already approved for marketing and manufacturing but there is proposed either to change the ratio of active ingredients or to make a new therapeutic claim.
4)Fixed Dose Combinations which have active ingredients those are widely used in a particular indication(s) for years individually their concomitant use is often necessary and no claim is proposed to be made other than convenience.