DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)d) Classification of the products in reference countries.For classification of MDDCI products as decided by the committee, please referTable III and it shall be used as guidance for classification only.Table III: Summary of Product Classification DecisionNO. PRODUCT INTENDED PURPOSE OR INDICATION CATEGORY1 Eye Lubricant A sterile substance used to provide supplementallubrication/ hydration to the natural eye to treat dry,tired, and/or strained eyes resulting from dry eyesyndrome, ageing/ hormone changes(menopause), or environmental factors (e.g.pollution and air conditioning).2 Irrigation solutions For mechanical cleansing and rinsing includingthose used in the eye such as for cleansing of theeye, body tissues, body cavities, wounds orirrigation of a special tube called a catheter whichis used to drain the bladder.3 Medical gases To be used in anaesthesia and inhalation therapy,including their primary containers.4 Medical gases For in-vivo diagnostic purposes including lungfunction tests.MEDICAL DEVICEMEDICAL DEVICE(If it containspharmacologically activesubstance, it will be classifiedas DRUG)DRUGDRUG5 In vivo diagnosticagents6 Hyaluranon basedproducts used as;For diagnostic purposes, carrier solutions tostabilize micro bubbles for ultrasound imaging.DRUGa) Synthetic-fluidtissuereconstructivematerialb) Synovial jointreplacement fluid(Joint lubricant)To correct cutaneous contour deformities of theskin (e.g. wrinkles, folds, scars), particularly incases of ageing or degenerative lesions, or as asubmucosal implant in the urinary tract for urinaryincontinence or vesicoureteral reflux. It may alsobe injected into the vocal cords to treat the effectsof paralysis, atrophy, or scarring.To help cushion the joint, especially in cases ofendogenous synovial fluid reduced viscosity fromdegenerative disease.MEDICAL DEVICEMEDICAL DEVICENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 46