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All India Institute of Medical Sciences, Nagpur

The Department of Ophthalmology conducted a CME on Advances in Ophthalmic Drug Quality: Drug Master Files, on 21st October 2023

The Department of Ophthalmology conducted a CME on Advances in Ophthalmic Drug Quality: Drug Master Files, on 21st October 2023 from 12.30 to 1.30 pm.  Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. Since DMF comprises complete, accurate information about Active Pharmaceutical Ingredient reviewed by USFDA as per US pharmacopoeia and International Council of Harmonization prescribed guidelines. This ensures that the same quality of manufacturing facilities is audited every year, ensuring better quality standards for medications.

DMF though voluntarily submitted by the manufacturer, is an assurance of quality worldwide. Usually, the Indian patients are supplied a lower quality product than western patients. This might be a matter of concern. Availability of DMF grade medications in India assures us of better and more effective drugs with higher bioavailability to our patients. In the field of Ophthalmology, these drugs are less common. However, with greater awareness, this too has started now.

The CME was briefed by experts representing the field of drug manufacture and attended by all Faculty, Senior residents, Junior residents, Nursing staff and Optometrists.