DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Figure 1:PRHNote:Numerical notations shown in the above figure are in line with the numberingfor the parameters, shown in Table 1 above, to be included in the product label(as identified and adopted by the ACCSQ-PPWG).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 350
Drug Registration Guidance Document (<strong>DRGD</strong>)9.1.2 PROPOSED PACKAGE INSERTPackage insert (PI) is required for products containing scheduled poison. PI mayalso be submitted for OTC products. The draft copy of the PI shall be submitted forevaluation.Sharing of PI is only allowed for products having the same active ingredient(s) butwith different strengths.The following information is required to be included in the PI:a) Brand or Product Nameb) Name and Strength of Active Substance(s)c) Product Descriptiond) Pharmacodynamics/ Pharmacokineticse) Indicationf) Recommended Dosageg) Route of Administrationh) Contraindicationsi) Warnings and Precautionsj) Interactions with Other Medicamentsk) Statement on usage during pregnancy and lactationl) Adverse Effects/ Undesirable Effectsm) Overdose and Treatmentn) Incompatibilities (For injections only)o) Storage Conditions (may be omitted if the information is stated on the labelor outer carton labels)p) Dosage forms and packaging availableq) Name and address of manufacturer/ product registration holderr) Date of revision of PINational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 351
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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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