DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)[2] Dosage FormPlease select dosage form and further select „in the form of‟ from the dropdownlist.For example, a tablet may be in the form of chewable, coated (enteric,film, or sugar), uncoated, dispersible, effervescent, extended release,subligual, etc.The form that correctly describes it in terms of its product quality controlspecifications and performance shall be selected.A separate application for registration is required for each dosage form.[3] Active Ingredientsi) Name of Active Ingredient:Please refer Appendix 8.1 List of Prohibited and Restricted ActiveIngredients and Combinations.Please select active ingredient from the search database by clickingbutton „click here to search‟. If an active ingredient is not listed in thedatabase, please click button „Not Listed Ingredient‟. Automatic e-mailwill be send to NPCB for verification. Please ensure that the spelling isaccurate.The actual raw material that is employed in the manufacturing processshall be named. For example:- Where the raw material used is the salt (e.g. ampicillin trihydrate)which will yield an equivalent effective component from its basecontent (i.e. ampicillin), the substance name is the salt and theequivalent base component should be indicated in remarks onsubstance (if any) field. ***- Similarly where a chemical is a component in the ingredient (e.g.iron in ferrous sulfate; or EPA and DHA in fish oil), the componentdetails shall be stated in the remarks field if a label claim of thecomponent 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.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 436