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Many fixed dose drug combinations for sale in India are not approved

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2517 (Published 13 May 2015) Cite this as: BMJ 2015;350:h2517
  1. Ingrid Torjesen
  1. 1London

Large numbers of fixed dose drug combinations—formulations that contain two or more active compounds in a fixed ratio of doses—are being sold to patients in India without having been approved by central regulatory authorities for safety and efficacy, research published this week in PLOS Medicine has found.1

In 2012 an Indian parliamentary committee reported that state authorities had issued manufacturing licenses for “large numbers” of fixed dose drug combinations despite their not having been approved by the Indian central drug licensing agency (the Central Drugs Standard Control Organisation) and warned that this could be …

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