DOC: NMPB-GFCP-01(CD) DRAFT STANDARD FOR GOOD FIELD .
DOC: NMPB-GFCP-01(CD)DRAFT STANDARD FOR GOOD FIELD COLLECTION PRACTICES OFMEDICINAL PLANTS
0. FOREWORD0.1 India has a rich heritage of plant based healthcare systems like Ayurveda, Unani and Siddhawith a very high degree of societal acceptance. The world is witnessing a change in the healthseeking behavior as more and more people world over are seeking health remedies through theuse of traditional and herbal medicines. There is a global upsurge in the use of traditional andcomplementary systems of medicine. This is primarily due to the fact that these systems ofmedicine, being largely plant based, are generally safe, efficacious and affordable. Theincreasing demand of natural/herbal products world over, therefore, creates a need not only forconserving medicinal plants but judicious utilization large potential in the service human kind ashealth care products. Over exploitation is leading to unsustainable collections from naturalforests resulting in uncertain availability of a large number of medicinal plants species and theirdecline in the wild.0.2 Forests have been the main source of the raw material used in the manufacture of Ayurveda,Siddha and Unani medicines. But concerns have been raised that unsustainable collection fromthe wild has resulted in a large number of species entering the red data book. Almost 90 percentof the raw materials of medicinal plants used by the manufacturing units are sourced fromnatural forests, often with little regard to environmental and social considerations, often resultingin harvest much in excess of sustainable limits.0.3 The major challenges facing growth and outreach of the traditional/herbal medicinal productsis their quality, safety and efficacy. This inter-alias is dependent on the quality of the rawmaterial used in the manufacture of the finished product. It is for this reason that development ofGood Field Collection Practices for medicinal plants will go a long way in improving the qualityof the final products. The National Medicinal Plants Board (NMPB), Department of AYUSHhas prepared India specific guidelines on Good Agriculture Practices (GAPs) on the pattern ofGood Agriculture and Field Collection Practices (GACPs) developed by the World HealthOrganization (WHO) for medicinal plants.0.4 In the preparation of this standard assistance has been taken from Good Agriculture and FieldCollection Practices (GAFCPs) developed by the World Health Organization (WHO) in 2003and Good Agricultural Practices enunciated by the GLOBALGAP Secretariat which is beingimplemented in over 80 countries.0.5. The requirements given in this standard are subject to the following statutory and regulatoryprovisions:a) The Drugs and Cosmetics Act and Rules (as amended up through 30th June 2005. NewDelhi: Department of Health. 2005.Schedule T: Good Manufacturing Practices (GMPs)for Ayurveda, Siddha and Unani Medicines.b) The Ayurvedic Pharmacopoeia of India, 5 Volumes, Ministry of Health and FamilyWelfare, Govt. of India, New Delhi, 1989-2005c) The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare,Govt. of India, New Delhi, 2007Page 2 of 43
d) The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt.of India, New Delhie) Indian herbal Pharmacopoeia, Revised Edition, Indian Drugs Manufacturers Association,Mumbai, 2002f) Quality Standards of Indian Medicinal Plants, 4 Volumes, Indian Council of MedicalResearch, New Delhi, 2003-2004g) The Indian Forest Act, 1927h) Wild Life (Protection) Act, 1972i) Biological Diversity Act 2002Page 3 of 43
1. SCOPEThis standard covers Good Field Collection Practices for wild medicinal plants insustainable manner and maintaining quality of produce used by all stakeholders.This standard does not cover the requirements for Good Agricultural Practices (GAPs)2. DEFINITIONS AND ABBREVIATIONS2.1 Definitions-For common understanding by the stakeholder in uniform manner, applicableterms have been defined and is given in Annex A2.2 Abbreviations- Abbreviations used in this standard are given in Annex G3. REQUIREMENTS3.1 The standard provides requirements for Good Field Collection Practices on different aspectsfor harvesting and post harvest management of medicinal plants. The details of requirements isgiven in Table 014. APPRAISALS AND ASSESMENT4.1The requirements stated in Table 01 shall be evaluated to establish that collectors complywith those requirements. An appraisal and assessment system has been developed. On evaluationof deficiencies that may appear in evaluation need to be resolved to establish compliance to therequirements. These deficiencies have been classified as:Critical:When evidence shows that the grower has not complied with requirements in itsdocumentation and implementation and which raises doubts on the operation and practice ofGAP calling for an early correction and corrective actions within the time frame.Major: When evidence suggests major break down in the implementation in certain elements ofthe criteria calling for the early corrective actions within a time frameMinor:When evidence shows an isolated non-compliance to the GAP criteria and has negligibleimpact on the operation of the system and its results.Note: Multiple Minor NCs with related impact on the operation of the system in one particulararea may result in major NC4.2 To develop a self-assessment against the criteria, a checklist has been developed and is givenin Table 02. This will bring uniformity in evaluation of the system. This also indicates when aviolation of a particular criteria leads to critical, major or minor nonconformities.Page 4 of 43
TABLE 01 REQUIREMENTS ANF EVALUATION CRITERIAParas Control criteriaCompliance criteria11.1SITE SELECTION FOR COLLECTIONThe site for collection of medicinalInformation on exposure of theplant produce should be free from toxiccollection place from insects,elements and from places not prone tochemicals, toxic gases, sewage,contamination1.2Are the sites close to road with heavyvehicular traffic?1.3Does the site is known as a reliablesource for the species intended tocollect?Does the site have gregariouspopulations of the intended species?COMPLIANCE TO REGULATORYGeneralAre the collection, processing, storageand sale of medicinal plant producecarried out in accordance with theexisting lawsAre the collection, processing, storageand sale of medicinal plant producecarried out in accordance with theinternational treaties and conventionssigned by India1.422.12.1.12.1.22.22.2.12.2.2Level ofcomplianceInternational regulation andguidelinesAre the provisions laid down in theCITES regulations adhered to whilecollecting any medicinal plant producefrom the wild?.Are the collection managers andcollectors of the medicinal plantproduce meant for export, honourexisting laws of the importingcountries?Majorautomobiles etc., also from or nearanthills, industrial areas, sewagelines, crematoria, hospitals, miningsites, public utilities, automobileworkshopsHarvested/collected from plants closeto roadside as perpetual exposure tovehicular exhaust renders the plantand its produce unsuitable for humanconsumption.Site survey report from an authorizedagencyMinorMajorSite survey report from an authorizedagencyREQUIREMENTMajorThis needs compliance to lawsenacted by both Central and localGovernments (See Clause 0.5)CriticalThe various international treaties andconventions related to conservationof biodiversity signed by India mustbe respected while collecting anymedicinal plant produce from thewild.CriticalThe collection managers andcollectors should be imparted on theprovisiond of CITES and theregulation copy must be available onsiteBesides the regulatory authorities inthe country of import, localsecretariats of CITES, IUCN andTRAFFIC may be consulted for suchlaws and regulations.CriticalCriticalPage 5 of 43
Paras Control .1National regulationsWhether the provisions of IndianForest Act 1927, The Wildlife(Protection) Act 1972, The Forest(Conservation) Act 1980, TheBiological Diversity Act 2002, TheScheduled Tribes & Other TraditionalForest-Dwellers (Recognition ofForest Rights) Act 2006 followed?Whether collectors and collectionmanagers keep themselves updatedabout the provisions in such Acts,Rules and abide by the conditions laiddown in themWhether managers and collectors areaware of Export-import policy and thenegative list of export in order tocomply with the provisions laid downin such policy documents?Local regulationsAre the collectors/collection managersaware of the local regulationsgoverning the collection, transit andsale of the medicinal plant produce inspecific areas and abide by them?Compliance criteriaLevel ofcomplianceA register of regulations (ROR)containing applicable provisions ofvarious Acts and Rules should beavailable at siteCriticalTraining and awareness records ofmanagers and collectors onregulatory requirementsMajorExistence of negative list of exportand policies on themMajorROR of local regulations enacted bystates such as The Madhya PradeshSustainable Harvesting Act 2005,The Andhra Pradesh Red SandersWood Possession Rules 1989, TheHP Forest Produce Transit (LandRoutes) Rules, 1977, The TamilNadu Sandalwood Transit Rules,1967, and The Maharashtra ForestProduce (Regulation of Trade) Act,1969. etc.CriticalPermission for enpriorwrittenpermission from the authorized agencyfor collection, possession, transit andsale of the medicinal plant produce,when required under law?The documentary proof of such Criticalpermissions must be kept in safecustody. Such medicinal plantproduce, when traded, must beaccompaniedbyappropriatedocumentation in accordance with thelaws and regulationsHARVEST/COLLECTION MANAGEMENTGuidelines given in Annex B must be kept in mindQuality ConsiderationsBotanical authenticity of species:Are the botanical identity established The species collected should be the CriticalPage 6 of 43
Paras Control criteriabefore a plant species are collectedfrom the wild. Is the identity of theplant from which the produce is beingcollectedverifiedandrecordsmaintained? The information soughtshould include - genus, species, subspecies, if any, along with newHow the identity of new medicinalplant species being collected, whichdoes not have any monographs in anyof the pharmacopoeias or referencebooks maintained?3.1.33.1.43.1.5Level ofcomplianceCompliance criteriaIs Field Collection Protocol available?same as given in AyurvedicPharmacopoeiaofIndia,Homoeopathic Pharmacopoeia ofIndia, Siddha Pharmacopoeia ofIndia, Unani Pharmacopoeia of India,IndianPharmacopoeia,,IndianHerbal Pharmacopoeia, or anyrecognized reference books likeICMR Monographs, or Major Herbsof Ayurveda .Where ever prior testing is done toauthenticate the identity, the voucherspecimens should be preserved in anappropriate manner along with thetest reportsMajorThe identity of new medicinal plantspecies should be established inconsultation with BSI or FRI or anyrecognized national or regionalherbaria.An operating manual/ collectionMajorprotocol applicable for the botanicalspecies should be made available atthe site for the collectors/ collectionmanagerSuch manual/ protocol should bedrafted in the local language usingsimple & instructional text.Plants, which are infested with MajorCollection of healthy plantsAre only healthy individuals of desired insects, pests, fungi, bacteria or virus,plant species harvested except when should be avoidedthe medicinal value of the speciescomes from such associations as in the Criteria for selection of healthy plantscase of insect galls, agar wood etc?should be laid down well withspecific reference to the species- inthe Operation manual/ Collectionprotocol.For those species where right stage of CriticalHarvesting at right phenologicalcollection is not known, collectionstage:managers must establish guidance inIn order to ensure optimum quantity consultation with finished productPage 7 of 43
Paras Control criteriaCompliance criteriaLevel ofcomplianceof biologically active substances in themedicinal plant produce, is harvestingdone at the right phenologicaldevelopmental stage?3.1.63.1.7manufacturers for such medicinalspecies for herbal formulations.The collection time in terms ofphenological stage of plant speciesalong with dates and months for eachmedicinal plant must be documented( See Annex F)Harvesting should not be done during MajorWeather conditions for collection:rain, mist or exceptionally highIs harvesting done under right weather humid conditions, as this wouldcondition?encourage fungal attack.When harvesting in wet conditionsbecomes inevitable, do provisions Collection should not be done duringexist to dry the water content as soon early hours to avoid dew, unless it isa specific need for any produce (e.g.as possible from the produce?floral parts like stigmas and anthers MinorIs the collection avoided during early are better harvested under dew).hours to avoid dew?The field collection protocol relatedto species should make a specificreference on a need basis, to idealweather conditions for collection.Sorting of produce:Are the medicinal plant produce sortedout from any immature or overmaturedproduce,whichmaydowngrade the overall quality of thelot?When trading is based grades ofproduce, is parameter of sorting andgrading defined objectively?3.1.8When such a reference is made in theprotocol, appropriate records relatedto the weather conditions prevailingon the date of collection should bemaintained at the site.There should be sorting and grading Majorprocedure sort out from immature orover mature to maintain the overallquality of the lot. Where trading ofdifferent grades of produce is invogue, grading should also be done inaccordancewithestablishedparameters. The basis of such grade- Majorwise sorting should be definedobjectively (e.g. diameter of roots,size or weight of the fruit etc.) .Foreign matter:Are care taken to avoid any accidentalmixing of foreign matter withmedicinal plant produce such as soilparticles, organic matters like leaves,Procedure should exist to avoid any Majoraccidental mixing with soil particles,organic matters like leaves, stems,wood pieces or food articles duringPage 8 of 43
Paras Control criteriaCompliance criteriaLevel ofcompliancestems, wood pieces or food articles the harvesting and post harvestbeing inadvertently mixed?management. Also to avoid anyAre collectors vigilant to avoid mixing and cross-contamination withmixing and cross-contamination with other medicinal plant produce being Majororprocessedother medicinal plant produce being neously?3.1.9Mixing of Toxic weeds:Are care taken to ensure that whileharvesting, no toxic weeds growing inclose vicinity get mixed withmedicinal plant produce?3.23.2.1Environmental ConsiderationsConservation status of species:Are Regulators (e.g. forest and wildlife field officials) and the collectorsaware of the current conservationstatus of the desired plant species?3.2.2Sensitive species:Are collection managers aware ofendemic plant species available in theareas of collection?3.2.33.2.43.2.5No toxic weeds growing in close Majorproximity get mixed with medicinalplant produce while harvesting theproduce. Collectors should know thephenotype of such weedsThe RET status of the plant species in Criticalthe respective areas should beavailable and any existing regulationapplicable in the area of collection toconserve such species should beadhered to.The managers must adhere to the Majorexistinglegalandecologicalprescriptions to ensure that thespecies is not subjected to anincreased threat.Distribution of species:Collection of a species should only be MajorAre quantity of collection of any plant done from areas where its frequencyspecies in proportion to the of occurrence is sustainable.distribution of the species in the areaof collection?For sustainability, certain percentage MajorRegeneration of species:of medicinal plant population shouldAre medicinal plant species harvested be left so as to allow the naturalwithin the limits of their capacity for regeneration. The population size toregeneration?be left may vary from species tospecies, depending on the habit andintrinsic regenerative capability of thespecies. This information should beavailableFrequency of collection:Are enough gaps left irrespective of Enough gaps should be given for the Minorthe demand of any medicinal plant plant to recoup the harvested parts.Page 9 of 43
Paras Control criteriaLevel ofcomplianceCompliance criteriaproduce, in its collection cycle to Data on regeneration cycle andsynchronize with the regeneration collection cycle should be available.cycle of the plant species or theproduce?3.2.63.2.73.33.3.13.3.2Minimizing the harm to sourceplant: While collecting the desiredplant parts such as leaves, fruits,flowers, seeds etc. are efforts made tominimize harm to the plant fromwhich these parts are being harvested?Cutting the branches to ease Minorcollection of its bearings (fruits,leaves, flowers etc.) should not beattempted. Proper guidelines shouldbe availableGuidelines should exist to minimize Majordamage to habitat of speciesWhile harvesting, do collectors ensure especially where roots or otherminimum damage to habitat of the underground parts are to be harvestedspecies to ensure sustainability?which result in uprooting of theassociated species of no interest tocollectors.Care should be taken that climbersand twiners while harvested causeleast disturbance to associated plantspecies. Certain species only occur inspecialized habitats (e.g. Acoruscalamus in waterlogged areas orBergenia ciliata syn. Bergenialigulata on rock crevices).Habitat management:Social Considerations:Local people enjoy certain bonafide Majorrights over the wild resources forfood, fodder, fuel wood, medicines,wild craft, agricultural implementsetc. under the regulations.Further, local healers in India collectmedicinal plant produce for use asraw materials for their medicinalrecipes from forests. The organizedcollection of medicinal plant producefrom the wild should not affect theavailability of species for use by localpeople. (ISSC-MAP Criterion 4.1:Traditional use, access rights, andcultural heritage)Fair Pricing: Do the collectors of Provisions should be laid down for a MinorLocal use of the species: Does theorganized collection of medicinalplant produce from the wild affect thebonafide rights and availability ofspecies for use by local people?Page 10 of 43
Paras Control criteria3.3.33.3.444.1Compliance criteriaLevel ofcompliancemedicinal plant produce get returns fair price mechanism for all thecommensurate with their efforts?species that are harvested in the area.Mechanismfor a fair and equitable MinorBenefit Sharing: Is there amechanism evolved for a fair and benefit sharing should be evolved andequitable benefit sharing that are adhered to by all the stakeholders ofadhered to by all the stakeholders of medicinal plant produce as providedfor in The Biological Diversity Act,medicinal plant produce?2002.Cultural Considerations: Are the Some plant species like Tulsi Minorharvestandthepost-harvest (Ocimum spp.), Doorba (Cynodonmanagement of medicinal plant dactylon), Bael (Aegle marmelos),produce carried out in accordance with Peepal (Ficus religiosa), Mangoethical codes and norms of local (Mangifera indica) etc. are attachedcommunity and the region in which with social and religious values.the activities take place and Due Local people may not allowed thesespecies to be harvested. Due respectrespect given to these values?should be given to such values duringharvestingandpostharvestmanagement of medicinal plantproduce.POST HARVEST MANAGEMENTGuidelines given in Annex B must be kept in mind. In addition, the collectors /collection managers should be provided with a M
India, Unani Pharmacopoeia of India, Indian Pharmacopoeia,, Indian Herbal Pharmacopoeia, or any recognized reference books like ICMR Monographs, or Major Herbs of Ayurveda . Where ever prior testing is done to authenticate the identity, the voucher specimens should be preserved in an
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for Ayurveda, Siddha and Unani Medicines. b) The Ayurvedic Pharmacopoeia of India, 5 Volumes, Ministry of Health and Family Welfare, Govt. of India, New Delhi, 1989-2005 c) The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare, Govt. of India, New Delhi, 2007
The Siddha Pharmacopoeia of India, Part I(1), Ministry of Health and Family Welfare, Govt. of India, New Delhi, 2007 d. The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt. of India, New Delhi 0.6 In preparation of this standard, considerable assistance ha
archaeological resource within a particular area or 'site' in order to make an assessment of its merit in context (using the HER, historic maps and other resources) Post-excavation Assessment (PXA) It is fairly unlikely that you will need to produce one of these as they are generally a planning requirement and/or for large sites with lots of finds. A post- excavation assessment report should .
