DOC: NMPB-GFCPMP-01(FD) GOOD FIELD COLLECTION PRACTICES .

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DOC: NMPB-GFCPMP-01(FD)GOOD FIELD COLLECTION PRACTICES STANDARDFOR MEDICINAL PLANTS - REQUIREMENTSPage 1 of 44

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 productsare 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 44

d) The Unani Pharmacopoeia of India, Part-I, Ministry of Health and Family Welfare, Govt.of India, New Delhie) The Indian Forest Act, 1927f) Wild Life (Protection) Act, 1972g) Biological Diversity Act 2002Page 3 of 44

1. SCOPEThis standard covers Good Field Collection Practices for wild medicinal plants in sustainablemanner 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 are 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 44

TABLE 01 REQUIREMENTS AND EVALUATION CRITERIAParasControl criteria11.1SITE SELECTIONThe site for collection of medicinalplant produce should be free from toxicelements and from places not prone tocontaminationCompliance criteriaLevel ofcomplianceInformation on exposure of thecollection place from insects,chemicals, toxic gases, sewage,automobiles etc., also from or nearanthills, industrial areas, sewage lines,crematoria, hospitals, mining sites,public utilities, automobile workshopsHarvested/collected from plants closeto roadside as perpetual exposure tovehicular exhaust renders the plantand its produce unsuitable for humanconsumption.Site survey report from an authorizedagencyMajor1.2Are 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 gregariousSite survey report from an authorizedpopulations of the intended species? agencyCOMPLIANCE TO REGULATORY REQUIREMENTGeneralAre the collection, processing,This needs compliance to laws enactedstorage and sale of medicinal plantby both Central and localproduce carried out in accordanceGovernments (See Clause 0.5)with the existing lawsAre the collection, processing,The various international treaties andstorage and sale of medicinal plantconventions related to conservation ofproduce carried out in accordancebiodiversity signed by India must bewith the international treaties andrespected while collecting anyconventions signed by Indiamedicinal plant produce from the wild.International regulation andguidelinesAre the provisions laid down in theThe collection managers andCITES regulations adhered to whilecollectors should be imparted on thecollecting any medicinal plantprovision of CITES and the regulationproduce from the wild?.copy must be available on siteAre the collection managers andBesides the regulatory authorities incollectors of the medicinal plantthe country of import, localproduce meant for export, honoursecretariats of CITES, IUCN andexisting laws of the importingTRAFFIC may be consulted for suchcountries?laws and regulations.National regulationsWhether the provisions of IndianA register of regulations (ROR)1.422.12.1.12.1.22.22.2.12.2.22.32.3.1.Page 5 of ritical

Paras2.3.22.3.32.42.4.12.52.5.133.13.1.1Control criteriaCompliance criteriaForest Act 1927, The Wildlife(Protection) Act 1972, The Forest(Conservation) Act 1980, TheBiological Diversity Act 2002, TheScheduled Tribes & OtherTraditional Forest-Dwellers(Recognition of Forest Rights) Act2006 followed?Whether collectors and collectionmanagers keep themselves updatedabout the provisions in such Acts,Rules and abide by the conditionslaid down in themWhether managers and collectors areaware of Export-import policy andthe negative list of export in order tocomply with the provisions laiddown in such policy documents?Local regulationsAre the collectors/collectionmanagers aware of the localregulations governing the collection,transit and sale of the medicinal plantproduce in specific areas and abideby them?containing applicable provisions ofvarious Acts and Rules should beavailable at siteLevel ofcomplianceTraining and awareness records ofmanagers and collectors on regulatoryrequirementsMajorExistence of negative list of exportand policies on themMajorROR of local regulations enacted bystates such as The Madhya PradeshSustainable Harvesting Act 2005, TheAndhra Pradesh Red Sanders WoodPossession Rules 1989, The HP ForestProduce Transit (Land Routes) Rules,1977, The Tamil Nadu SandalwoodTransit Rules, 1967, and TheMaharashtra Forest Produce(Regulation of Trade) Act, 1969. etc.CriticalPermission for collectionsHavethecollectors/collectionmanagers taken prior writtenpermission from the authorizedagency for collection, possession,transit and sale of the medicinal plantproduce, 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: The species collected should be theAre the botanical identity (genus, same as given in statutory documents Criticalspecies etc) established before a (See 0.5). Where ever prior testing isplant species are collected from the done to authenticate the identity, thePage 6 of 44

ParasControl criteriaCompliance criteriaLevel ofcompliancewild. Is the identity of the plant from voucherspecimensshouldbewhich the produce is being collected preserved in an appropriate mannerverified and records maintained?along with the test reports3.1.2Botanicalplants:authenticityofHow the identity of new medicinalplant species is collected, which doesnot have any monographs in any ofthe pharmacopoeias or referencebooks ionProtocolCollection of healthy plantsAre only healthy individuals ofdesired plant species harvestedexcept when the medicinal value ofthe species comes from suchassociations as in the case of insectgalls, agar wood etc?Harvesting at right phenologicalstage:In order to ensure optimum quantityof biologically active substances inthe medicinal plant produce, isharvesting done at the rightphenological developmental stage?3.1.6Weather conditions for collection:Is harvesting doneweather condition?underMajornewrightWhen harvesting in wet conditionsbecomes inevitable, do provisionsexist to dry the water content as soonas possible from the produce?Is the collection avoided during earlyhours to avoid dew?The 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/ collectionmanager.Such manual/ protocolshould be drafted in the local languageusing simple & instructional text.Plants, which are infested with insects, Majorpests, fungi, bacteria or virus, shouldbe avoidedCriteria for selection of healthy plantsshould be laid down well with specificreference to the species- in theOperationmanual/Collectionprotocol.CriticalThe 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 Majorrain, mist or exceptionally high humidconditions, as this would encouragefungal attack.Collection should not be done duringearly hours to avoid dew, unless it is aspecific need for any produce (e.g.floral parts like stigmas and anthersare better harvested under dew).MinorThe field collection protocol related tospecies should make a specificPage 7 of 44

ParasControl criteriaCompliance criteriaLevel ofcompliancereference on a need basis, to idealweather conditions for collection.3.1.7Sorting of produce:Are the medicinal plant producesorted out from any immature or overmatured produce, which maydowngrade 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 related tothe weather conditions prevailing onthe 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, sizeor weight of the fruit etc.) .Foreign matter:Is care taken to avoid any accidentalmixing of foreign matter withmedicinal plant produce such as soilparticles, organic matters like leaves,stems, wood pieces or food articlesbeing inadvertently mixed?Procedure should exist to avoid any Majoraccidental mixing with soil particles,organic matters like leaves, stems,wood pieces or food articles during theharvestingandpostharvestmanagement. Also to avoid anyAre collectors vigilant to avoid mixing and cross-contamination withmixing and cross-contamination other medicinal plant produce being Majorwith other medicinal plant produce harvested or processed simultaneouslybeing harvested or processedsimultaneously?3.1.9Mixing of Toxic weeds:Are care taken to ensure that whileharvesting, no toxic weeds growingin close vicinity get mixed withmedicinal plant produce?3.23.2.1No toxic weeds growing in close Majorproximity get mixed with medicinalplant produce while harvesting theproduce. Collectors should know thephenotype of such weedsEnvironmental ConsiderationsThe RET status of the plant species in Criticalthe respective areas should beAre Regulators (e.g. forest and wild available and any existing regulationlife field officials) and the collectors applicable in the area of collection toaware of the current conservation conserve such species should beConservation status of species:Page 8 of 44

ParasControl criteriaCompliance criteriaLevel ofcompliancestatus of the desired plant species?3.2.23.2.33.2.43.2.53.2.5 a3.2.5.b3.2.6adhered to.The managers must adhere to the MajorSensitive species:existinglegalandecologicalAre collection managers aware of prescriptions to ensure that the speciesendemic plant species available in is not subjected to an increased threat.the areas of collection?Distribution of species:Collection of a species should only be MajorIs 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 shouldAremedicinalplantspecies be left so as to allow the naturalharvested within the limits of their regeneration. The population size to becapacity for regeneration?left may vary from species to species,depending on the habit and intrinsicregenerative capability of the species.This information should be availableBaseline Assessment& Monitoring:Is baseline assessment done of Based on the baseline data available, Majorthe regular monitoring should beavailability of medicinal plantcarried out of availability of medicinalproduce in the wild?plant produce in wild as a part ofroutine management plan. Baselineassessment should be done byadoptingmathematicalmodelsincluding computer soft wares.Are assessments done on sustainable The assessment should also be done Majorfor sustainable level of harvesting forlevel of harvest?each species at least for those likely tobe threatened in short durations.Frequency of collection:Are enough gaps left irrespective ofthe demand of any medicinal plantproduce, in its collection cycle tosynchronize with the regenerationcycle of the plant species or theproduce?3.2.7Enough gaps should be given for the Minorplant to recoup the harvested parts.Data on regeneration cycle andcollection cycle should be available.Minimizing the harm to sourceplant: While collecting the desired Cutting the branches to ease collection Minorplant parts such as leaves, fruits, of its bearings (fruits, leaves, flowersPage 9 of 44

ParasControl criteriaCompliance criteriaLevel ofcomplianceflowers, seeds etc. are efforts made etc.) should not be attempted. Properto minimize harm to the plant from guidelines should be availablewhich these parts are delines should exist to minimize Majordamage to habitat of species especiallyWhile harvesting, do collectors where roots or other undergroundensure minimum damage to habitat parts are to be harvested which resultofthespeciestoensure in uprooting of the associated speciessustainability?of no interest to collectors.Care should be taken that climbers andtwiners while harvested cause leastdisturbance 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 use of the species: Does theorganized collection of medicinalplant produce from the wild affectthe bonafide rights and availability ofspecies for use by local people?Local people enjoy certain bonafide Majorrights over the wild resources for food,fodder, fuel wood, medicines, wildcraft, agricultural implements etc.under the regulations.Further, local healers in India collectmedicinal plant produce for use as rawmaterials for their medicinal recipesfrom forests. The organized collectionof medicinal plant produce from thewild should not affect the availabilityof species for use by local people.(ISSC-MAP Criterion 4.1: Traditionaluse, access rights, and culturalheritage)EquityDo the collectors of medicinal plant Provisions should be laid down for a Majorproduce get returns commensurate fair price mechanism for all thespecies that are harvested in the area.with their efforts?Is there a mechanism evolved for a Mechanism for a fair and equitable Majorfair and equitable benefit sharing that benefit sharing should be evolved andare adhered to by all the stakeholders adhered to by all the stakeholders ofmedicinal plant produce as providedPage 10 of 44

Paras3.3.444.14.1.14.24.2.14.2.24.34.3.14.3.2Level ofcomplianceControl criteriaCompliance criteriaof medicinal plant produce?for in The Biological Diversity Act,2002.Some plant species like Tulsi Minor(Ocimum spp.), Doorba (Cynodondactylon), Bael (Aegle marmelos),Peepal (Ficus religiosa), Mango(Mangifera indica) etc. are attachedwith social and religious values. Localpeople may not allow these species tobe harvested. Due respect should begiven to such values during harvestingand post harvest management ofmedicinal plant produce.Cultural Considerations: Are theharvestandthepost-harvestmanagement of medicinal plantproduce carried out in accordancewith ethical codes and norms of localcommunity and the region in whichthe activities take place and Duerespect given to these values?POST HARVEST MANAGEMENTGuidelines given in Annex B must be kept in mind. In addition, the collectors/ collection managers should be provided with a Manual/ Operative protocolfor all stages of post-harvest management. The manual / protocol should bedrafted in the loc

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

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