DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)component is made for the product, and the actual raw materialused declared as the active ingredient.International Non-proprietary Names (INN), approved names,pharmacopoeia names of ingredients shall be used whenever possible.After each ingredient entry is correctly made, click the button „add/save‟. The button „remove‟ will allow for corrections to an entry underthis heading. To remove item, please select item from the listing andclick „remove‟.ii) Strength of active ingredient:Please enter strength of active ingredient (numerical) and then selectunit weights and measures from the drop-down list.Content of ingredients shall be expressed as appropriate in thefollowing manner :a. quantity per dose unit(e.g. for unit dose formulations - tablet, capsule, lozenge, etc.)b. percentage composition - %w/w, %w/v, %v/v, etc.(e.g. for products without defined dose unit such as ointments,creams, solutions, etc.)c. weight per ml.(e.g. for solutions, injections, etc.)d. quantity (percentage or amount) per measured dose(e.g. oral liquids, metered aerosols, drops, etc.)Metric weights and measures shall be used.In cases where product contains active ingredient(s) that cannot bedefinitely identified (e.g. certain biological products) state the name ofthe material to which activity is ascribed and, where appropriate, thepotency or activity of the product.iii) Remarks on active ingredient (if any):***This field shall be used where the raw material in product formulationyields an equivalent active component.After each ingredient entry is correctly made, click the „add/ save‟ button. Theremove button will allow for corrections to an entry under this heading. Toremove item, select item from the listing and click remove.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 431