DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Table V: Method of Evaluation According to Product CategoriesMethod of EvaluationNo.Product CategoryFullEvaluationAbridged Evaluation1. New Drug Products √ Not Applicable2. Biologics √ Not Applicable3.Generics(Scheduled Poison)√Not Applicable4.Generics(Non-ScheduledPoison)[or known as OTC]* All productsfrom thiscategory,unless statedin AbridgedEvaluationIncludes, but not limited to the following:Antiseptics/ skin disinfectants;Locally-acting lozenges/ pastilles;Topical analgesic/ counter-irritants;Topical nasal decongestants;Emollient/ demulcent/ skin protectants;Keratolytics;Anti-dandruff;Oral care;Anti-acne;Medicated plasters/ patch/ pad; andTopical antibacterial.5.Health Supplementsa) General orNutritional Claimsb) FunctionalClaims (Medium)c) Disease RiskReduction Claims(High)Not ApplicableNot Applicable√√√Not Applicable6. Natural Products Not Applicable √National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 72
Drug Registration Guidance Document (DRGD)* Table VI:Products containing Glucosamine, Chondroitin and Methylsulphonylmethane (MSM)No.ProductProductCategoryRoute ofEvaluationConditionon ProductIndicationRemark1.ProductscontainingGlucosamineAs singleactiveingredientAscombinationwithChondroitinand/or MSMOTCOTCFullevaluationFullevaluationAs adjuvanttherapy forosteoarthritisAs adjuvanttherapy forosteoarthritisAs combinationwith othersupplementingredients areNOT allowed tobe registeredAs singleingredient2.ProductscontainingChondroitinORIncombinationwith othersupplementingredientsHealthsupplementAbridgedEvaluationNotherapeuticclaims areallowed-As singleingredient3.ProductscontainingMSMORIncombinationwith othersupplementingredientsHealthsupplementAbridgedEvaluationNotherapeuticclaims areallowed-AscombinationwithChondroitinHealthsupplementAbridgedEvaluationNotherapeuticclaims areallowed-Reference: Circular Bil (66) dlm BPFK/02/5/1.3National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 73
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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