Supply chain and Management System based Standardization of Botanicals
In recent years with ever-growing commercialization in the field of herbal medicines, inadvertent contamination, substitution and intentional adulteration with pharmaceutical drugs in herbal plants and products are common practices. The challenges are innumerable and enormous, making the global herbal market potentially unsafe. Generally, quality control and quality assurance activities cover the entire supply chain and include good practices throughout the supply chain from cultivation to the point of use by the consumer. In practice, good manufacturing practices are used to address safety requirement of medicinal plants and herbal medicines primarily during the processing of harvested medicinal plants for conversion into products intended for consumer use. This talk seeks to enlighten physicians, pharmacists, consumers, manufacturers and stake holders in herbal medicine of the need to establish quality parameters for cultivation, collection, handling, processing and production of herbal medicines as well as employ such parameters in ensuring the safety of the global herbal market. The processes of good quality assurance and standardization of herbal medicines and products will also be discussed in detail with regard to WHO guidelines. This presentation will cover current perspectives for addressing all aspects for supply chain quality control and assurance of botanicals from cultivation to consumer use, an attempt has been made for a sequential study of the quality control of herbal medicinal products (HMP) starting from selection of medicinal plants; good agricultural practices (GAP); cultivation; good field collection practices (GFCP); organized and unorganized drugs; source and period of collection; identification; storage chemical standardization; assay; good manufacturing practices (GMP); pharmacological study to clinical approach, with special reference to maintain standardization at each and every stage. Modern techniques used for quality, safety and quality control will be discussed in detail to outline the challenges of standardization with special reference to marker compounds in plant species and their fingerprinting. Practical experiences of laboratory work on inadvertent contamination and substitution as well as intentional adulteration with pharmaceutical drugs in herbal plants and products will been discussed in detail.