Fixed Dose Combinations of anti ‐tubercular, anti‐malarial, and anti‐retroviral medicines on the Indian market: Critical analysis of ubiquity, sales, and regulatory status

ConclusionA large proportion of FDC formulations available in India has never been approved by CDSCO, hence raising the doubts about their safety and efficacy. An opaque regulatory framework and ambiguity over licencing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.This article is protected by copyright. All rights reserved.
Source: Tropical Medicine and International Health - Category: Tropical Medicine Authors: Tags: Original Article Source Type: research