DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No. Subject Matter Example(s) Notesmay cause confusion Radix Ginseng which isimprovised as a male sexualorgan22. Statement on sugars in traditionalproductsExample:- This product contains no sugar-This product contains no addedsugarAllowable on product label provided theproduct contains no fructose, glucose,sucrose or other kind of sugars with apotential to affect diabetics are notincluded in the formulation23. Other statements Example:- This product is blended withpremium quality- Certified chemical residue freeProhibited on product labelNotes:The Authority reserves the right to disallow any other words, phrases or graphics for product label which in its opinion ismisleading, improper or not factual.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 298
Drug Registration Guidance Document (<strong>DRGD</strong>)3. PRODUCT SPECIFIC REQUIREMENTS3.1 FOOT PATCHESA foot patch which contains herbs with a health claim needs to be registered with theAuthority.Summary of registration for foot patches is described below:a) Product Indication- Traditionally used fora) General health;b) Promoting blood circulation;c) Relieve fatigue.- If there are other indications other than those mentioned above, applicant isrequired to submit clinical study data to support the proposed indication.b) Active ingredient/ Excipient- May only contain active ingredient which are classified under the category ofNatural Products (Traditional).- Pharmaceutical ingredients which have dual-function as an active ingredientand excipient, e.g. Vitamin C can be used as excipient.- However the maximum allowable amount for the excipient in the traditionalproduct has to follow the pharmacopoeia limits established. If for example inthis case the amount of Vitamin C is more than 0.1%, the product shall beclassified as an OTC product. The product will then have to fulfill therequirement for the registration of an OTC product.c) Certificate of Analysis for Finished Product- It is required with at least one batch data for registration.d) Certificate For Free Sale- CFS from the regulatory authority of the country of origin of the productdepending on the product classification of that product in that countryNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 299
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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