DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)No. Non-Permissible Product Names Example6.7.8.9.10.11.12.Prohibited use of names which may beoffensive or indecentProhibited use of product names whichare incoherent with the approvedindicationName containing a product claim whereasproduct is indicated for more than theapproved indicationProhibited use of product names whichhas elements of ludicrous beliefStatements referring to ancient believe/negative spirits/ supernatural powerProhibited use of product names similarto the existing approved product namesProduct names similar to the spelling andpronunciation of words of the existingproduct namesProhibited use of product names whichmay cause ambiguity in the nature ofproduct (drug/ food/ beverage)Product names similar to a food/ beverageproductProhibited use of product names whichrepresents professional advice oropinion or referring to the professionProhibited use of product names whichrepresent weight loss/ slimmingpropertiesExample:SENXBIG=SEnXBIG(label)Sexy, Enjoy, Paradise,Heavenly, Blue boy, Casanova,Desire(Dezire),Sensual(Xenxual),Asmara,SyokExample:Cough Syrup X= Approvedindication for cough, dizziness, fluand itchExample:Words such as miracle, magic,magical, miraculous, saintly,heavenlyExample:Tenormin vs Tenormine vsTenormyRe-Liv vs Re-LifExample:Juice, Health drink, Beverage,KookyExample:Dr Sunny, Dr Noortier RooiboseTea, Professor, Herbalist, DoctorExample:Slim, Langsing, Trim, Trimnfit,Sleen, Kurus, Susut perutNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 270
Drug Registration Guidance Document (DRGD)No. Non-Permissible Product Names Example13.Prohibited use of product namesreferring to any religious contentExample:Maksum, Mahmudah, Arifbillah14. Other prohibited product namesExample:Minda, IQ, Smart, Genius, UltraMega, DetoxNote:The Authority reserves the right to disallow any other words or phrases for productnames which in its opinion is misleading, improper or not factual.2.5 QUALITY CONTROL2.5.1 SAMPLE FOR TESTINGSample for testing shall be submitted to the Drug Analysis Division, NPCBwithin 14 days of payment confirmation by the NPCB.For further information, please refer Section C: Guideline for Submissionof Product Samples for Laboratory Testing in the main DRGD.2.5.2 APPEAL FOR SAMPLE RETESTINGAppeal for retesting must be submitted through on-line registration systemwithin 30 days from the date the results are sent to the applicant. Samplessubmitted after the 30 days grace period will not be entertained. Theapplication will then be tabled to the Authority for rejection.2.5.3 QUALITY TESTING FOR SPECIFIC INGREDIENTi) For product containing Aphanizomenon flosaquae, applicants would haveto provide certificates of analysis showing that the microcystin-LR or totalmicrocystins content of the raw material does not exceed 1μg/g and theNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 271
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: Drug Registration Guidance Document
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
Page 274 and 275: Route of AdministrationTAMC(CFU/g o
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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