DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Endangered Species Act 2008 (Act 686). If the ingredient is from alocal source, a special permit/ license shall be obtained from the:Division of Protection and Quarantine of Plants,Department of Agriculture,Tingkat 1-3, Wisma Tani,Jalan Sultan Salahuddin,50632 Kuala Lumpur.Tel: +603 - 20301400, Fax: +603 - 26913550.2.2 EXCIPIENTSa) Excipients are substances used to assist in the manufacture of activesubstance into dosage forms suitable for administration to consumers. Eachexcipient ingredient included in a formulation must have a justifiable excipientrole and shall be controlled by specifications. The intended use of anexcipient shall be appropriate.b) New excipient will require safety and/or other additional data to support thefunction in the product prior to addition into the Quest 3 database.2.3 INDICATIONS2.3.1 INDICATIONS ACCEPTABLE FOR NATURAL PRODUCTSa) General Health Maintenance/ Kesihatan Am“Traditionally used…./ “Digunakan secara tradisional….“Digunakan secara homeopati untuk.../ “Homeopathically used....1. For general health/ for health/ untuk kesihatan.2. General health maintenance/ for general well being.3. For health and strengthening the body/ untuk kesihatan danmenguatkan badan.4. For relief of body heatiness/ untuk melegakan panas badan.5. For general debility, weakness after illness or childbirth/ untuk letihlesu/ kelesuan badan selepas sakit atau selepas bersalin.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 266
Drug Registration Guidance Document (<strong>DRGD</strong>)6. For loss of appetite/ untuk kurang selera makan.7. For difficulty in sleep/ bagi melegakan kesukaran untuk tidur.8. For relief of fatigue/ untuk melegakan kepenatan.9. As an aid to overcome fatigue during physical exertion/ membantumelegakan kepenatan fizikal.10. To expel wind and invigorate vital energy/ untuk membuang angin danmenambah tenaga.11. To improve appetite/ untuk menambah selera makan.12. For relieving waist ache and body weakness/ untuk melegakan sakitpinggang dan lemah anggota badan.13. For relieving dizziness, sweating, and difficulty in sleep/ untukmelegakan pening, berpeluh berlebihan dan sukar untuk tidur.14. For reducing body odour/ untuk mengurangkan bau badan.15. For reducing toothache/ untuk mengurangkan sakit gigi.16. To relieve tired eyes/ untuk melegakan kepenatan mata.17. For healthy eyes/ untuk kesihatan mata.b) Blood & Body Fluid/ Darah & Cecair Badan“Traditionally used…./ “Digunakan secara tradisional….1. For improving blood circulation/ untuk melancarkan perjalanan darah.2. To improve urination/ untuk melawaskan kencing/ buang air kecil.3. For improving bowel movement/ untuk melawaskan buang air besar.4. For relieving mild vomiting/ untuk melegakan muntah ringan.5. For reducing minor swelling/ untuk melegakan bengkak-bengkakringan.c) Bone, Muscle & Joint/ Tulang, Otot & Sendi“Traditionally used…./ “Digunakan secara tradisional….1. For strengthening muscle and bone/ untuk menguatkan otot dantulang.2. For relieving muscular ache/ untuk melegakan sakit otot.3. For relieving waist ache and backache/ untuk melegakan sakitpinggang dan sakit belakang.4. For relief of joints and muscular pain/ untuk melegakan sakit sendi danotot.5. For relieving muscles sprain/ untuk melegakan terseliuh/ terkehel.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 267
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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