DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)11.2.2 STEP 1: PRODUCT VALIDATIONAll fields are compulsory to be entered.Option is given either to accept the validation result and submit; or overrideand manually select.Once validation is verified and submitted, the related application form underStep 2 will be displayed.Information entered in Step 1 will be captured in the database and need notbe re-entered at Step 2.[1] Product NameProduct name, dosage form and strength shall be entered.(e.g. X Brand Paracetamol Tablet 500mg)Product name is defined as a name given to a product which may beeither a proprietary name (an invented name); or a generic name(common name) or scientific name, together with a trade mark or thename of the manufacturer.Product name shall not imply the following:a. Tricky, confusion and against the law;b. Scandal and offensive;c. Prejudice;d. Well-known;e. The name which may sound like or had been used for a product thathas been revoked due to safety concerns;f. Any other name which deemed inappropriate by the Authority.The invented name shall not be liable to confusion with the commonname.The generic name means the international non-proprietary namerecommended by WHO (rINN), or if one does not exist, the usualapproved name.The product name shall be shown on the product labelling i.e. immediatelabel, outer unit carton, package insert and patient information leaflet.Dosage form and strength of product would need to be entered as part ofproduct name to allow for multiple dosage forms (e.g. tablet, capsule) andstrengths (e.g. 200mg and 400mg) for any particular named (proprietary orgeneric) product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 429