Regulatory Aspects of Herbal Regulatory Aspects of Herbal Medicines in Nepal Medicines in Nepal Radha Radha Raman Prasad, Chief Drug Administrator, Raman Prasad, Chief Drug Administrator, MoHP MoHP Navin Navin P. P. Shrestha Shrestha , Senior Drug Administrator, DDA , Senior Drug Administrator, DDA Gajendra Gajendra B. B. Bhuju Bhuju , Drug Administrator, DDA , Drug Administ rator, DDA Presented at International Presented at International Arogya Arogya 2007 2007 Conference New Delhi, Oct. 2007 Conference New Delhi, Oct. 2007
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►► In order to promote the drugs underIn order to promote the drugs under Ayurvedic Ayurvedic,,
Homeopathic , Traditional and other system ofHomeopathic , Traditional and other system ofmedicines, the production of drugs for which themedicines, the production of drugs for which the
formula is well documented under their recognizedformula is well documented under their recognized
literatures will be facilitated both at governmentalliteratures will be facilitated both at governmentaland private sectors.and private sectors.
►► The drugs based on these formulas as well asThe drugs based on these formulas as well as
other ingredients will be modernized into dosageother ingredients will be modernized into dosageforms and be subjected to scientific evaluation forforms and be subjected to scientific evaluation for
their safety, efficacy and quality.their safety, efficacy and quality.
►► Activities related to drugs under Activities related to drugs under Ayurvedic Ayurvedic,,
Homeopathic , Traditional and other systemHomeopathic , Traditional and other systemof medicines will be developed suitablyof medicines will be developed suitably
involving qualified personnel and relatedinvolving qualified personnel and related
technologist.technologist.
►►TheThe Ayurvedic Ayurvedic department will conduct anddepartment will conduct and
coco--ordinate all technical activities related toordinate all technical activities related to Ayurvedic Ayurvedic drugs.drugs.
►►Governing Act:Governing Act: Drug Act 1978Drug Act 1978
►►National Authority for Drug Control:National Authority for Drug Control:Department of Drug Administration (DDA),Department of Drug Administration (DDA),Government of Nepal, Ministry of Health andGovernment of Nepal, Ministry of Health and
Population is National Regulatory Authority (NRA)Population is National Regulatory Authority (NRA)
Medicines Laboratory (NML) is the principal bodyMedicines Laboratory (NML) is the principal bodyof Government of Nepal for scientific research,of Government of Nepal for scientific research,testing and analysis of drug.testing and analysis of drug.
Drug Registration Requirements:Drug Registration Requirements:
Domestic ProductsDomestic Products
►►Obtaining the letter of recommendation forObtaining the letter of recommendation forthe establishment of drug industriesthe establishment of drug industries
►►Obtaining the product licenseObtaining the product license
►►Registration for sale/distribution of productsRegistration for sale/distribution of products
(National Guidelines for GMP)(National Guidelines for GMP)
Documents Required for Registration ofDocuments Required for Registration of
Medical Products:Medical Products:
►► Application for product registration in prescribed Application for product registration in prescribedform.form.
►► Application for product import recommendation Application for product import recommendationletter in the prescribed form.letter in the prescribed form.
►► Attested copy of Valid Certificate of Attested copy of Valid Certificate ofPharmaceutical Products (CPP) as recommendedPharmaceutical Products (CPP) as recommendedby WHO (Attested by National Regulatoryby WHO (Attested by National Regulatory
Authority or Notary Public). Authority or Notary Public).
►► Detail formulation including recipients, color, flavorDetail formulation including recipients, color, flavoretc.etc.
►►Methods of analysisMethods of analysis►► Samples of the product (2Samples of the product (2--unit packs), labelsunit packs), labels
and cartoonand cartoon
►► Analytical report from own lab and from any of Analytical report from own lab and from any ofthe laboratories for the same batchthe laboratories for the same batch
►► Government laboratory of the exporting countryGovernment laboratory of the exporting country
or Nepal (Nepalese laboratories)or Nepal (Nepalese laboratories)
(approved by Government of Nepal.(approved by Government of Nepal.
Commitments for the promotion ofCommitments for the promotion of
Herbal Medicines:Herbal Medicines:
►►Restriction on use of unnecessary, irrationalRestriction on use of unnecessary, irrational
and harmful medicinesand harmful medicines
►►Registration on Scientific Basis for QualityRegistration on Scientific Basis for Quality
Assurance Assurance►► Amendment of Act and Regulation for Amendment of Act and Regulation for
export promotion in the context of WTOexport promotion in the context of WTO
►►Implementation of National Guidelines onImplementation of National Guidelines onGMP (2007) for manufacturing HerbalGMP (2007) for manufacturing Herbal
SAARC Region Rich in Plant ResourcesSAARC Region Rich in Plant Resources
Many examples on use of HerbalMany examples on use of HerbalMedicines since itMedicines since it’ ’ s Part of Culturals Part of CulturalHeritage in the RegionHeritage in the Region
Many old testaments and literaturesMany old testaments and literaturesavailable on herbal medicines in theavailable on herbal medicines in theregion.region.
Globally more & more people gettingGlobally more & more people gettingattracted towards use of herbal medicinesattracted towards use of herbal medicines
►►Regional coordination / coRegional coordination / co--operations/operations/Networking for the research activitiesNetworking for the research activities
►►
Developing joint monographsDeveloping joint monographs►►Developing quality control techniquesDeveloping quality control techniques