DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1. INTRODUCTIONRegulation 7(1)(a) of the Control of Drugs and Cosmetics Regulations (CDCR) 1984requires all products to be registered with the Authority prior to being manufactured,sold, supplied, imported or possessed for sale, unless the product is exempted underthe specific provisions of the regulations.Under Regulation 2, CDCR 1984, “Homeopathic medicine” means anypharmaceutical dosage form used in the homeopathic therapeutic in which diseasesare treated by the use of minute amounts of such substances which are capable ofproducing in healthy persons symptoms similar to those of the disease being treated.This would include preparations that are to be chewed, sucked, swallowed wholeand applied topically.Applicants are reminded that it is their responsibility to ensure that their productscomply with these regulations and also other related legislations namely:(i) Sale of Drugs Act 1952(ii) Dangerous Drugs Act 1952(iii) Poisons Act 1952(iv) Medicines (Advertisement & Sale) Act 1956(v) Wildlife Protection Act 19722. EXEMPTIONAll homeopathic products are registrable under the Control of Drugs and CosmeticsRegulations 1984. Exemption to this are:i) single homeopathic potentised dilution;ii) extemporaneous preparation for an individual patient by a registered/ licensedhomeopathic practitioner;iii) All Mother Tinctures;iv) Unmedicated sugar globules and tablets.3. PREPARATION NOT CONSIDERED BY THE AUTHORITY FOR REGISTRATIONThe Authority will only register homeopathic products used for oral administration,nasal or mouth sprays and external application only. The following dosage forms willnot be considered for registration.- Sterile preparations such as eye-drops and injectables;National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 302
Drug Registration Guidance Document (DRGD)- Suppositories and vaginal tablets;- Transdermal patch;- Sublingual preparations;- Preparation in combination with non-homeopathic active ingredient, such asvitamins, minerals and herbs.- Preparations containing substance listed in the Poison List (except Attachment 1).4. INGREDIENTSHomeopathic products are prepared from natural or synthetic sources that arereferenced in pharmacopoeia monographs or other recognized documents. Notconsidering imponderable, the source materials for homeopathic medicines mayconsist of the following:- Plant material such as: roots, stems, leaves, flowers, bark, pollen, lichen, moss,ferns and algae;- Microorganisms such as: fungi, and plant parasites;- Animal materials such as: whole animals, animal organs, tissues, secretions;- Minerals and chemicals.For each medicinal ingredient, a copy of the monograph from the pharmacopoeia towhich the applicant attests must be provided. Also for homeopathic medicines with aspecific claim, it must be supported by the same level of evidence as for traditionalproducts.Products containing a combination of homeopathic and non-homeopathic medicinalingredient will not be evaluated as a homeopathic product.4.1 POSITIVE LISTHomeopathic medicinal ingredients are allowed as multi ingredient inhomeopathic products and the active ingredient must be documented in amonograph as a homeopathic medicinal ingredient as stated in the currentedition of Homeopathic Pharmacopoeias recognized by the Authority listed inAttachment 3.Homeopathic products are allowed to be registered when the homeopathicmedicinal ingredients used in their products are more than 2C or 4X.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 303
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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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