DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)11.2.1 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, confusive and against the law;b. Scandalous and offensive;c. Prejudicial;d. Notorious.Any product name which is the same or similar either in writing/pronunciation, with the product name of an adulterated product or aproduct that has been revoked due to safety concerns is prohibited.The invented name shall not be liable to confusion with the commonname.The generic name means the international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.If a product name is found similar to another registered product or anyother name which deemed inappropriate by the Authority, NPCB reservesthe rights to request for the change of the product name.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 435