Are Fixed dose combinations(FDCs) really successful?

General
1

FDCs are mainly prescribe for chronic condition such as Diabetes,TB,HIV etc for better patient compliance , and increasing adherence to the therapy.

some fdcs are used in which one component decreaes the side effect of the another , example : triple drug(amlodipine,indapamide,telmisartan : for antihyptersion and prevent recurrent stroke) etc.

there are various other successful examples but the problem lies in marketing of some fdcs that do not offer any therapeutic advantage over monotherapy at the same time costly than the single pill.

last year in April 2025 CDSCO released banned drug list of fdcs and asked the state authority to review their approval process and follow the NDCT Rules 2019 under the Drugs & Cosmetics Act 1940.

how does these drugs got approved and marketed even though there was no rationale behind it?

Patient usually have a mindset that one pill is less effective than 2 pills, and above that if such FDCs are marketed ofcourse it will not provide any benefit to the patient and they might loose trust in the therapy and FDC might loose their significance…

1 Like
2

Yes, maybe we all share some responsibility. Patients mostly trust the medications prescribed by healthcare professionals, so the burden lies on the shoulders of practitioners to verify whether these FDCs are approved by regulatory authorities like the CDSCO. Furthermore, regulatory bodies need to be much more vigilant to ensure such irrational combinations are not allowed into the market in the first place.

1 Like
3

your point about marketing-driven combinations is very valid. Some FDCs may get approved due to gaps in regulation, inconsistent state approvals, or commercial pressure despite lacking strong clinical evidence. Strict regulatory review and evidence based prescribing are essential to preserve the real value of FDCs and ensure patient safety.