Scaling Up : A few initiatives8. Various steps are being undertaken by different stakeholders of the sector to overcome the bottlenecks and scale-up. A fewsuch initiatives have been illustrated below.Accreditation councils and Clinical research centersAs per Mr Darshan Shankar, Executive Chairman – Institute of Ayurveda & Integrative Medicine, the foremost step for upscalingshould be creation of accreditation councils for clinics and hospitals along with steps like distributing free software forstandardized documentation for clinical management. Other measures that could help the sector are establishing world classcommon facilities for quality control and using NMPs.Raw Material Sourcing• Dr N B Brindvanam, Member – NMPB Technical Committee states that in order to increase the exports to the growingmarkets, India needs to focus on QMS with focusing on both good agricultural practices and good field collection practices.• According to Mr T Balakrishnan, IAS, Additional Chief Secretary Industries & Commerce Department, Government ofKerala, India need to promote cultivation of medicinal plants while implementing good agricultural practices and promotingsingle point sourcing of raw materials.Manufacturing and StandardizationPoor standardization results in varying characteristics in products and hence, lesser acceptability in the global market. As perDr Nimish Shroff, Director – Charak Pharma Private Limited, it is essential to achieve world standards through quality inprocess and adopting the global standards of GMPs of WHO to ensure exports to regulated markets. The GMP outlines practicesto be incorporated for:• QMS as documented in quality manual with focus on procedures, change controls, failure investigation, quality complaintsand vendor development• Personnel with focus on qualification, training and responsibility of quality assurance/control• Premises and equipment with focus on cleaning and sanitization program, pest control, air handling unit systems,equipment identification, status labeling and maintenance• Documentation with focus on standard operating procedures, master formula cards, batch manufacturing records, material,equipment, utility and product specifications• Manufacturing with focus on technology transfer, stringent manufacturing operations and environmental monitoring• Quality control and assurance with focus on control of laboratory operations, sampling procedures, analysis certificates,control of retention samples and annual product review• Inspection with focus on regulatory inspections and self inspectionIntegrating Ayurveda with TourismIntegrating Ayurveda with tourism will also help promote not only the core competencies of Ayurveda but also tap theinternational market.• According to Dr Anil Kumar, Executive Director, Kerala Ayurveda Limited, India needs to focus on curative aspects of Ayurvedawhile Mr Rajiv Vasudevan, Member -NABH Technical committee advocates Government to encourage more hospitals andmedical centres to obtaining NABH accreditation (currently only 40 hospitals and 3 nursing homes accredited).Policy and CertificationsIt is an imperative for India to work further on a stricter guideline for herbal products in line with global forces like EU (THMPD),USA (DSHEA), Canada (NHPD) and Australia (ARGCM).42• As per Mr Anil Jauhri, Director – NABCB QCI, certifications at both domestic and international levels are required. In lineto the requirements, a multi stakeholder committee has been setup by Department of AYUSH with technical and certificationcommittee setup by QCI with main elements of the scheme being certification criteria and standards, certification process,internal quality assurance protocols and rules for using certification marks• According to Ms Shobha Hegde, Advisor to QCI, the Government in association with QCI are working towards developingregulations in line with international process of regulation due to drawbacks in the traditional process. An accreditation bodywill be working with conformity assessment bodies for ensuring voluntary certification and quality assurance. The regulatorsin the process are FSSAI for accreditation of CABs, WDRA for certifications of warehouses and inspection of commoditiesand DGCI for medical devices regulation. For AYUSH regulation, professional inspection bodies accredited to ISO 17020 willsupplement the inspection machinery and primary onus of compliance will be on industry to get itself inspected by any of theinspection bodies.According to Mr Ranjit Puranik, General Secretary to Ayurvedic DMA, India needs to utilise full potential of CRISM andadopt a plan for implementation of THMPD as the current XIth year plan has outlined various promotion measures for AYUSHresearch and it is essential to work towards implementation.Development of clustersAccording to Dr A K Krishna kumar, Head – Agri Business for IL&FS Clusters, formation of clusters so as to counter thedisadvantages, like lack of economies of scale and scope, of the fragmented MSME industry is a critical step for up-scaling the sector.
Conclusion: GROW framework9. Ayurveda is slowly emerging as an independent medical knowledge system and to increase its acceptability and adaptability,India needs to focus on a GROW framework:Globalization of AyurvedaResponsible practicesOrganizational approachWealth sharingNeed for adoption of standardized western pharmaceutical methods to comply with US,Europe and WHO guidelinesCultivating a system of sustainable harvesting and protection of species together with goodagricultural, manufacturing and healthcare practicesShift from home based to mass scale production by adopting cutting edge technologiesfor identification of new pharmaceutical leads, creation of global brands and adoptingtechnology for manufacturing and service deliveryProtection of traditional inventive and creative activity against misappropriation of thirdparty patents and ensuring that the knowledge providers participate in the global marketand get benefitedAbbreviations and AcronymsAbbreviationsARGCMCABCRISMDGCIDMADSHEAFDAFSSAIGMPNABCBNABHNHPDNMPBQCITHMPDWDRAWHODetailsAustralian Regulatory Guidelines for Complementary MedicinesCertified Accreditation BodiesCentre for Research in Indian Systems of MedicineDrugs Controller General of IndiaDrugs Manufacturer’s AssociationDietary Supplement Health and Education ActFood and Drug AdministrationFood Safety and Standards Authority of IndiaGood Manufacturing PracticesNational Accreditation Board for Certification BodiesNational Accreditation Board for Hospitals & Healthcare ProvidersNational Health Products DirectorateNational Medicinal Plants BoardQuality Council of IndiaTraditional Herbal Medicinal Products DirectiveWarehousing Development and Regulation ActWorld Health OrganizationNote: This document has been prepared by <strong>CII</strong> and Deloitte based on interactions and deliberationsat the Global Ayurveda Summit <strong>2010</strong> held in Cochin on 25 & 26 March <strong>2010</strong>.43
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