DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Additional Requirements for Labelling‣ Product with dosage form of soft gel with tail (twist and squeeze) shallinclude the statement „Under parent supervision‟ in the label.‣ For products containing animal origin(s), please add this statement: Thisproduct contains substance(s) from animal origin.‣ For products containing porcine, please add this statement: This productcontains animal part(s) (porcine/pig).Health supplement products with disease risk reduction claims (high) areencouraged to be dispensed under the supervision of pharmacists or medicalpractitioners. At such, the label and package insert of health supplementproducts with disease risk reduction claims (high) shall have the followingstatement:“Please consult a healthcare professional before taking this product”.The front panel must contain the information as specified in DRGD. However,the information on the side panels is interchangeable. Additional cautionarylabelling relating to the safety of the product may be imposed.Specific Labelling Requirement (Label & Package Insert)1. ALFALFAThe following boxed warning shall be included on the labels of productscontaining Alfalfa (Medico sativa):This product contains Alfalfa (Medico sativa).Individual with a predisposition to systemic lupuserythematosus shall consult their phycisian beforeconsuming this product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 202
Drug Registration Guidance Document (DRGD)2. ARGININEThe following statement shall be included on the labels and in the packageinsert of oral preparations containing Arginine for health supplements:WARNING:Arginine is not recommended for patients following a heart attack.3. ASPARTAMEThe following statement shall be included on the labels and in the packageinsert of products containing Aspartame:WARNING:Unsuitable for phenylketonurics4. BEE POLLENThe following statement shall be included on the labels and in the packageinsert of product containing bee pollen:This product contains Bee Pollen and may cause severe allergicreactions, including fatal anaphylactic reactions in susceptible individuals.Asthma and allergy sufferers may be at greater risks.5. CHITOSANThe following statement shall be included on the labels and in the packageinsert of products containing chitosan.“DERIVED FROM SEAFOOD”6. GINKGO BILOBA/ GINKGO EXTRACTThe following statements shall be included on the labels and in the packageinsert of products containing Ginkgo Biloba/ Ginkgo Extract:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 203
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Page 152 and 153: Drug Registration Guidance Document
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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