DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)c) Aqueous/vitreous humourreplacementmedium7 Peritoneal dialysisdialysate8 HaemodialysisdialysateIt is used to assist in performing during ophthalmicsurgery, e.g. to maintain the shape of the eyeballduring the intervention, preserve tissue integrity,protect from surgical trauma, or to function as atamponade during retinal reattachment.It is used for the exchange of solutes across theperitoneum of the patient (in this case, used as asemi-permeable membrane)It is used for the exchange of solutes with bloodthrough a semi-permeable membrane in thedialyser of a haemodialysis system.MEDICAL DEVICEDRUGMEDICAL DEVICE9 Fluoride dentalpreparationsa) Oral care product To maintain oral hygiene.COSMETIC(If concentration of fluoride isless than or equal to1500ppm)To maintain oral hygiene and prevent oraldiseases.DRUG(If concentration of fluoridemore than 1500ppm)b) Fluoride dentalpreparations witha typical devicemode of action.10 Wound treatmentproducta) comprising amatrixb) comprising amatrixTo provide filling to the cavity and provide layer fordiseases prevention.To administer medicinal product.To provide protective layer/ barrier to preventmicrobial penetration and create healingenvironment.MEDICAL DEVICEDRUGMEDICAL DEVICEc) providing a matrix,typically of livingcells (fibroblasts)and/or structuralproteinsTo facilitate the infiltration of native skin elements(e.g., fibroblasts, leukocytes, blood vessels) forskin regeneration.MEDICAL DEVICEd) topical applicationto a skin wound(e.g. abrasion,laceration, cut,ulcer)To facilitate local haemostasis primarily throughhaemoglobin binding. It is available in variousforms (e.g. gel, spray, powder, ointment, plaster/gauze pad) that can be applied directly to thewound where it forms a seal of transparent layer.MEDICAL DEVICENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 47