Fixed-dose combinations banned in India: is it the right decision? An eye-opening review.

Abstract:

:Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in September 2018. The Drug Technical Advisory Board (DTAB) recommended that 'there is no therapeutic justification' for the active ingredients in the banned FDCs and accordingly these combinations 'may involve a risk to human beings'. Areas covered: The review illustrates the present status of FDCs, its regulatory framework, approvals in India and discusses the substantive cause behind the ban on FDCs in India. Expert opinion: The expert stress to establish a robust regulatory system for the approval of FDCs in India. The pharmaceutical industries should not perceive the ban against irrational FDCs as an impediment; rather, they should view as an opportunity to establish a stronger healthcare system. The current review is an eye-opener for the section of people who consider that the ban on FDCs is irrational. However, the ban on 328 FDCs may prove a landmark decision for the development of stronger healthcare policy in India.

journal_name

Expert Opin Drug Saf

authors

Miranda MRH,Dubey A,G S R,Charyulu RN

doi

10.1080/14740338.2019.1651292

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

977-985

issue

10

eissn

1474-0338

issn

1744-764X

journal_volume

18

pub_type

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