DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Outline:1. Introduction2. Exemptions3. Preparations not considered by the Authority for registration4. Ingredients5. Quality6. Good Manufacturing Practice7. Labelling8. Indications for useAttachments:• Attachment 1: List of exempted Single Homeopathic Potentised Dilutions• Attachment 2: Negative List• Attachment 3: List of acceptable references• Attachment 4: List of endangered animal species/ protected wildlifeNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 304
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 | 305
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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