DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)For product containing Momordica Charantia, please state:- “Shall not be used in pregnant and breast-feeding women.”- “Be sure to tell your pharmacist, doctor, or other healthcareproviders about any other supplements you are taking. There maybe a potential for interactions or side effects.”For product containing Pelargonium sidoides, please state:In very rare cases, pelargonium sidoides may causehypersensitivity reactionsFor product containing Propolis (topical preparation), please state:“Propolis may cause allergic skin reaction.”For product containing Propolis (for oral use), please state:- “This product contains propolis and may cause severe allergicreactions including fatal anaphylactic reaction in susceptibleindividuals.”- “Asthma and allergy sufferers may be at a greater risk.”For product containing Royal Jelly (for oral use), please state:- “This product contains royal jelly and may cause severe allergicreactions including fatal anaphylactic reaction in susceptibleindividuals.”- “Asthma and allergy sufferers may be at a greater risk.”For product containing naturally occurring SALICYLIC ACID (e.g. WillowSalix spp.), please state:- “People allergic to aspirin/ other NSAID should avoid thisproduct.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 290
Drug Registration Guidance Document (<strong>DRGD</strong>)For product containing Senna Leaf (Cassia) and Rhubarb/ Radix etRhizoma Rhei, please state:- “Do not use when abdominal pain, nausea or vomiting ispresent.”- “Frequent or prolonged used of this preparation may result independence towards the product and „imbalanced electrolytes‟.”For product containing St. John‟s Wort, please state:The product may interact with other medicines. Pleaseconsult a doctor/ pharmacist before using it.For product containing substance from seafood, please state:“Derived from seafood.”For product with indication “To regulate menstruation/ To improvemenstrual flow”, please state:“Contraindicated in pregnant women.”For product with indication „To reduce body weight‟, please state thesestatements, (unless proven otherwise):- “Balanced diet and regular exercise are essential.”- “Safety on long term use has not been established.”National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 291
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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