DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Use in Lactation:When the active substance(s) or its metabolites are excreted in milk,recommendations as to whether to stop or continue breast feeding, andthe likelihood and degree of adverse reaction in infant shall be stated.For abridged evaluation, please state any effect on pregnancy and lactation, ifapplicable.14. Side Effects/ Adverse ReactionsPlease state in order for severity and frequency, the side effects, adversereactions, toxic effects, etc. (i.e. reactions, toxic effects, other than thosedesired therapeutically) including reactions such as allergy,hypersensitivity, drug dependence, addiction, carcinogenicity, tolerance,liver/ kidney toxicity etc.Indicate also symptoms and sites of effects/ reactions.Reactions, whether minor or serious shall be stated.Severity, reversible, frequency of occurrence shall be indicated, whereverpossible.Clinical tests for detection of „sensitive‟ patients, measure for managementof adverse reactions developed shall be described wherever possible.15. Signs and Symptoms of Overdose and TreatmentPlease state briefly symptoms of overdose/ poisoning, and where possible,recommended treatment and antidotes for overdose/ poisoning.16. Storage ConditionsPlease state the recommended storage conditions (temperature, humidity,light etc.).Information include storage condition before first opening, afterreconstitution and/or after opening and for all the listed pack types shallalso be provided, where applicable. Stability data to support such storagecondition shall be submitted.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 444
Drug Registration Guidance Document (<strong>DRGD</strong>)17. Shelf LifeShelf life for all the listed pack types shall be supported by stability data.Information include shelf life before first opening, after reconstitutionand/or after opening where applicable shall also be provided. Stability datato support such shelf life shall be submitted.Evidence is required to demonstrate that the product is stable which meetsthe finished product shelf life specifications throughout its proposed shelflifeand toxic decomposition products are not produced in significantamounts during this period; potency, sterility and efficacy of preservative,etc. are maintained.18. Therapeutic CodePlease indicate WHO assigned ATC code for each distinct therapeuticindication proposed for a product, if such a code is available. Click button„click here to search‟ to search the code via database athttp://www.whocc.no/atcddd/.For natural products, please select “Traditional/ Homeopathy” from thelisted button.After completion of Section A has been done, please click Section List for display ofmain page of application form and select Section B: Product Formula, or click button„next‟ after saving the entered data.SECTION B: PRODUCT FORMULAa) For full evaluation requirement, B1.1 and B1.2 as described below is requiredunder Section B: Product Formula. Data pertaining to quality of product isrequired to be submitted under Part II: Quality of Product.B1.1 Batch Manufacturing FormulaPlease state batch size and actual batch manufacturing masterformula.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 445
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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