MPA 204T Herbal & Cosmetic Analysis PDF

See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/353526448 MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) Presentation · July 2021 DOI: 10.13140/RG.2.2.18629.78564 CITATIONS...

See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/353526448 MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) Presentation · July 2021 DOI: 10.13140/RG.2.2.18629.78564 CITATIONS READS 0 5,727 1 author: Dr Sumanta Mondal GITAM (Deemed to be University) 331 PUBLICATIONS 1,006 CITATIONS SEE PROFILE All content following this page was uploaded by Dr Sumanta Mondal on 28 July 2021. The user has requested enhancement of the downloaded file. MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II Unit – I: Herbal remedies- Toxicity and Regulations: Herbals vs Conventional drugs, Efficacy of herbal medicine products, Validation of Herbal Therapies, Pharmacodynamic and Pharmacokinetic issues. Herbal drug standardization: WHO and AYUSH guidelines. - Phytochemicals or traditional medicine are other terms for herbal medicine. Herbal medicine comprises herbs, herbal materials, herbal preparations, and finished herbal products that contain active component portions of plants or other plant materials, or mixtures thereof, according to the World Health Organization (WHO). Herbal medicine is commonly regarded as a necessary component of a dietary supplement. - phytomedicine or herbalism is a type of alternative and complementary medicine (CAM) that uses plants or their crude products for the treatment of diseases. It may include also animal, fungi or bacteria products. Whereas the conventional medicine, which uses pure chemicals regardless of their origin, natural or synthetic. - Other types of complementary medicine (CAM) like Physical therapy, Aromatherapy, Vacuum cups (cupping), Acupuncture, Phytopharmacology. A recently established field of drug research, dealing with the study of the interactions that occur between a living organism and natural drugs. - Herbal medicine is the use of plants or plant extracts for medicinal purposes (especially plants that are not part of the normal diet). Phytonutrient or nutraceutical or functional food Natural substances that aid the body to maintaining health and combating disease such as anthocyanidins, isoflavones and carotenoids. - Natural product is biosynthetic substances produced by living cells. - Crude Drug is a medically useful drug of plant or animal origin without any further processing or modification. ❖ Herbal drug toxicity and safety evaluation of traditional medicines - Complementary and alternative therapies differ in that the former are treatments that can work alongside and in conjunction with orthodox medical treatments, while the latter are those given in place of orthodox medicine and whose effects may be negated by orthodox medicines. - The following examples demonstrate the range of problems encountered with the use of herbal medicines and products. Some herbal products were found to contain 0.1–0.3 mg of betamethasone per capsule after some patients developed corticosteroid-like side effects. Owing to misidentification of the medicinal plant species, plant materials containing aristolochic acid were used for manufacturing herbal products, which caused severe kidney failure in patients in several countries. Reports have been received by drug safety monitoring agencies of prolonged prothrombin times, increased coagulation time, subcutaneous haematomas and intracranial haemorrhage associated with the use of Ginkgo biloba. One of the most well-known traditionally used herbal medicines caused severe, sometimes fatal cases of interstitial pneumonia when used in conjunction with interferon. - Action required: For the safety of those using herbal medicines, four complementary actions are needed: Clear identification of the nature of adverse events. Management of the risks. Institution of measure to prevent adverse events. Good communication of the risks and benefits of herbal medicines. Increased ability to learn from identified adverse events through better reporting systems, skilful technical investigation of incidents and responsible sharing of data. Greater capacity to anticipate adverse events and to probe systemic weaknesses that might lead to problems. Identification of existing knowledge resources, within and outside the health sector. Improvements in the health-care delivery system, so that structures are reconfigured, incentives are realigned, and safety and quality are placed at the core of the system. - Action needed by WHO to respond to these requests includes: Provision of technical guidance to facilitate the expansion of existing systems to monitor and report adverse drug reactions to herbal medicines or the establishment of comprehensive national drug safety monitoring systems that incorporate the safety monitoring of herbal medicines, where these do not yet exist. support to countries in strengthening their pharmacovigilance system for herbal medicines, allowing for the involvement of health-care providers, consumers and manufacturers. Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 1|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II - Where there is a national drug safety monitoring system in place, there is a clear need to expand its scope to include herbal medicines. If no such system exists, there is an urgent need to establish such a system, which should include monitoring of herbal medicines. However, adding herbal medicines to a list of target substances for a national drug safety monitoring activities is not enough in itself. Because of the particular nature of the distribution and use of herbal medicines, adequate and effective monitoring demands special requirements, including: Expanding the source of case reports, for example by: o Involving all providers of herbal medicines, including providers of traditional medicine and complementary/alternative medicine, according to national circumstances. o Strengthening the role of providers, such as pharmacists and health-care professionals, working in the community. o Involving manufacturers of herbal medicines. o Facilitating consumer reporting. o Developing systems of information exchange involving drug information centres, poisons centres, consumer organizations and manufacturers. Establishing a system for the exchange of regulatory and quality information on herbal medicines among national pharmacovigilance centres and national drug regulatory authorities. Strengthening capacity to carry out monitoring of herbal medicines at national pharmacovigilance centres by: o Training staff in relevant technical areas. o Ensuring access to facilities for analysing products suspected of causing adverse reactions. o Providing access to reliable information. Developing a standard classification and/or coding system for herbal medicines, with standardized terms and definitions strengthening communication and awareness at all levels (global, regional, national, local and community) and among key players (international bodies, regulatory authorities, national pharmacovigilance centres, health-care providers and consumers). - The objectives of these guidelines are to: Support Member States, in the context of the WHO International Drug Monitoring Programme, to strengthen national pharmacovigilance capacity in order to carry out effective safety monitoring of herbal medicines. Provide technical guidance on the principles of good pharmacovigilance and the inclusion of herbal medicines in existing national drug safety monitoring systems; and where these systems are not in place, to facilitate the establishment of an inclusive national drug safety monitoring system. Provide standard definitions of terms relating to pharmacovigilance, and safety monitoring of herbal medicines Promote and strengthen internationally coordinated information exchange on pharmacovigilance, and safety monitoring of herbal medicines among Member States. Promote the safe and proper use of herbal medicine. - The regulation of herbal medicines and their place in national health-care systems differs from country to country, and these guidelines will therefore need to be adapted to meet the needs of the local situation. Terms relating to herbal medicines: These terms and their definitions have been selected and adapted from other WHO documents and guidelines that are widely used by the WHO Member States, such as the General guidelines for methodologies on research and evaluation of traditional medicine. Herbal medicines: Which include herbs, herbal materials, herbal preparations and finished herbal products. In some countries herbal medicines may contain, by tradition, natural organic or inorganic active ingredients that are not of plant origin (e.g., animal and mineral materials). Traditional use of herbal medicines: Which refers to the long historical use of these medicines. Their use is well established and widely acknowledged to be safe and effective and may be accepted by national authorities. Therapeutic activity: Which refers to the successful prevention, diagnosis and treatment of physical and mental illnesses. Treatment includes beneficial alteration or regulation of the physical and mental status of the body and development of a sense of general well-being as well as improvement of symptoms. Active ingredients: Which refer to ingredients of herbal medicines with therapeutic activity. Where the active ingredients have been identified, the preparation of the finished herbal product should be standardized to ensure that it always contains a defined amount of the active ingredients, providing adequate analytical Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 2|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II methods are available. In cases where it is not possible to identify the active ingredients, the whole herbal medicine may be considered as one active ingredient. Traditional medicine: It refer that the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health and in the prevention, diagnosis, improvement or treatment of physical and mental illness. The terms “complementary medicine”, “alternative medicine” and “nonconventional medicine” are used interchangeably with “traditional medicine” in some countries. Terms relating to safety monitoring of medicinal products: The terms and definitions below have been adopted by the national pharmacovigilance centres participating in the WHO International Drug Monitoring Programme. Different medical paradigms may view clinical events differently in their relationship to herbal medicines, whether they are expected therapeutic outcomes or adverse reactions. Side effect: Any unintended effect of a pharmaceutical product occurring at doses normally used in humans that is related to the pharmacological properties of the drug. Adverse event/experience: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but that does not necessarily have a causal relationship with this treatment. Serious adverse event. Any untoward medical occurrence that, at any dose: o results in death o requires inpatient hospitalization or prolongation of existing hospitalization o results in persistent or significant disability/incapacity o is life-threatening. Adverse reaction: A response to a drug that is noxious and unintended, and that occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function. Unexpected adverse reaction: An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from the characteristics of the drug. Signal: Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. Spontaneous reporting: A system whereby case reports of adverse drug events are voluntarily submitted by health professionals and pharmaceutical manufacturers to the national regulatory authority. Pharmacovigilance: It is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. National pharmacovigilance centre: A single, governmentally recognized centre (or part of an integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety. Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 3|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II ❖ Efficacy of herbal medicine products - Herbal drugs have been used since ancient times as medicines for the treatment of a range of diseases. Medicinal plants have played a key role in world health. In spite of the great advances observed in modern medicine in recent decades, plants still make an important contribution to health care. - There are several herbal drugs that have their efficacy like: o Urtica dioica has been used for the management of most of immunological, hepatic and nephron damaging diseases. o Other medicines such as Echinacea commonly used in the management of common cold. o Ginseng is a similar plant with potential herbal activity. It has been used in the management of physical and cognitive performance and in the improvement of energy. o Ginkgo has been used as herbal plant for ages. It is indicated to possess about 24% flavonoids and about 6% terpenoids. Findings and reviews from previous controlled trials suggests that it may be an effective herbal extract for the management of the dementia. o Garlic has also been widely studied following the numerous claims of medicinal effect. It has been validated that it has significant potential in the management of cholesterol. It was able to lower cholesterol levels by about 5% on average. o St Johns worts have been effective in the management of mild depression [38,39]. However, it has been found not to work in the management of patients with severe depression. o Most people use Peppermint in the management of irritable bowel syndrome. o Ginger is used in tea and coffee and as a drug for the management of nausea. The potential of application of ginger in the management of post-operative nausea has also been evaluated in three randomized clinical trials. o Soy has been associated with its ability to lower the symptoms of menopause in women. o Chamomile is a common plant for the management of pain, sleep disorders, anxiety, and gastrointestinal problems. Even though the plant is considered safe, there are case reports that have identified serious allergic reactions. o Kava is also used as a sedative in many places, but mostly in the south pacific region. It is also a relaxant and has beneficial effects in the management of anxiety. Several studies have identified potential hepatotoxicity from the use of this extract - Phytotherapeutic agents are normally marketed as standardized preparations in the form of liquid, solid (powdered extract), or viscous preparations. They are prepared by maceration, percolation or distillation (volatile oils). Ethanol, water, or mixtures of ethanol and water are used for the production of fluid extracts. Solid or powered extracts are prepared by evaporation of the solvents used in the process of extraction of the raw material. - Compared with well-defined synthetic drugs, herbal medicines exhibit some marked differences, namely: The active principles are frequently unknown. Standardization, stability and quality control are feasible but not easy. The availability and quality of raw materials are frequently problematic. Well-controlled double-blind clinical and toxicological studies to prove their efficacy and safety are rare. Empirical use in folk medicine is a very important characteristic. They have a wide range of therapeutic use and are suitable for chronic treatments. The occurrence of undesirable side effects seems to be less frequent with herbal medicines, but well- controlled randomized clinical trials have revealed that they also exist. They usually cost less than synthetic drugs. - According to the phytomedicine market has grown at an expressive rate worldwide since 1985 (from 5 to 18% a year). Several important factors have contributed to the growth of this worldwide phytotherapeutic market, among which the following may be mentioned: o Preference of consumers for natural therapies. o Concern regarding undesirable side effects of modern medicines and the belief that herbal drugs are free from side effects, since millions of people all over the world have been using herbal medicines for thousands of years. o Great interest in alternative medicines. Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 4|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II o Preference of populations for preventive medicine due to increasing population age. o The belief that herbal medicines might be of effective benefit in the treatment of certain diseases where conventional therapies and medicines have proven to be inadequate. o Tendency towards self-medication. o Improvement in quality, proof of efficacy and safety of herbal medicines. o High cost of synthetic medicines. - Dietary supplements, including vitamins, minerals, and herbal remedies, are not regulated by either state or federal agencies. They have been classified by the FDA as dietary supplements these products may be in the form of tablets, capsules, soft gels, gel caps, liquids, teas, or powders. Their use is often justified based upon experience from trial and error, not rigorous scientific scrutiny. - Under the Dietary Supplement Health and Education Act (DSHEA) of 1994; the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. As a general rule, supplement manufacturers do not need to register with the FDA, prove product safety, or get FDA approval before producing or selling supplements. - The FDA monitors safety (e.g., voluntary dietary supplement adverse event reporting) and product information, such as labelling and claims. - The Federal Trade Commission regulates advertising of dietary supplements. Manufacturers must make sure that the product label is truthful and not misleading. They must list all ingredients contained in the product on the label and limit the claims (health claims, nutrient content claims, and structure/function claims) that can be made. Structure/function claims are those which claim that the nutrient is intended to affect normal structure or function in humans (i.e., "calcium builds strong bones"). - If a manufacturer makes a structure/function claim on the supplement label, DSHEA requires a disclaimer commenting: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 5|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II ❖ Validation of Herbal Therapies - Traditional Medicine (TM) has a long history of traditional use. However, the efficacies of some of these are unproven. The lack of evidence does not necessarily mean that TM lacks efficacy or is unsafe. - Some evidence of efficacy for herbal medicines, safety and quality, if they exist, are considered to be anecdotal or empirical at best and rarely is it subjected to the rigorous prospective randomized controlled trial. - Through a slow throughput process of clinical trial and error each culture developed a local, natural resources-based tradition of healing. These systems of traditional medicine, today, provide the basic drug supply for an estimated 4.6 billion people worldwide. - As for Example: ‘Triphala’ is a classical example of polyherbal formulation in Ayurveda having synergistic and counter balancing properties which contain dried fruits of Emblica officinalis Gaertn. (Euphorbiaceae), Terminalia belerica Roxb. (Combretaceae) and T. chebula Retz. (Combretaceae) in equal proportions (1:1:1), prescribed as laxative in chronic constipation, colon detoxifier, and as rejuvenator of the body due to its gallic acid and ellagic acid content47. These three fruits were mixed, and the polyphenols of those plants collectively produced synergistic effect and formulation have been validated. - Searching for the natural products in untapped sources can lead us to new horizons where we can find novel, potent and selective drug leads. Such leveraging innovations in the development of natural health products suggested an immense growth potential in future for their validation in every aspect. - However, for most herbal medicines, the therapeutic components have not been fully elucidated or easily monitored. The European Medicines Agency (EMEA) defines chemical markers as chemically defined constituents or groups of constituents of herbal medicinal product, which are of interest for quality control purposes in spite of whether they possess any therapeutic activity. Classification of different chemical markers can be as follows: o Therapeutic components o Bioactive components o Synergistic components o Characteristic components o Main component o Correlative components o Toxic components o General components - A total of 282 chemical markers are listed in the Chinese Pharmacopoeia (2005 edition) for the quality control of Chinese herbal medicines. As discussed in the monographs of the American Herbal Pharmacopoeia (AHP), the use of single or multiple chemical markers was important to quality control Apart from proper cultivation, collection and quality, optimum extraction and standardization of raw materials the evaluation of herbal medicine should be done in a better way to get meaningful results. - The starting point for plant based new drug discovery should be identification of the right candidate plants by applying traditional documented use, tribal non-documented use, and exhaustive literature search. Bioassay-guided Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 6|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II fractionation of the identified plant may lead to standardized extract or isolated bioactive compound as the new drug. This integrated approach could enhance success rate in drug discovery. - The development of Traditional Medicine requires the convergence of modern techniques and integrated approaches related to their evidence-based research in various fields of science through national and international coordination. - The integrated strategies of drug development from Traditional Medicine are as follows: - India has an ancient heritage of traditional system of medicine. Indian Materia-Medica provides a huge knowledge base on folklore practices of traditionally inspired medicine. Indian traditional medicine is based on AYUSH, with the emerging interest of the world in adopting and studying traditional systems, and in exploiting their potential from different healthcare perspectives, the Ministry of AYUSH, Government of India has initiated several attempts to explore the possibility of evaluating TMs for their therapeutic potential as originally practiced, as well as to generate data to put them in national healthcare programs. The Ministry of AYUSH regulates education, practice and encourages research in these systems. The National Medicinal Plant Board (NMPB) deals with conservation, cultivation, postharvest technology and related issues on medicinal plants. The detailed profile of Ministry of AYUSH, Govt. of India is given in the Table. Various organizations of Ministry of AYUSH, Govt. of India for exploration and development of TM Ministry of AYUSH, Govt. of India Organizations Particulars Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India Central Council for Research in Siddha (CCRS), Tamil Nadu, India Research councils Central Council for Research in Unani Medicines (CCRUM), New Delhi, India Central Council for Research in Homoeopathy (CCRH), New Delhi, India Central Council for Research in Yoga & Naturopathy (CCRYN), New Delhi, India Board National Medicinal Plant Board (NMPB) National Institute of Ayurveda (NIA), Jaipur National Institute of Naturopathy (NIN), Pune National Institute of Unani Medicine (NIUM), Bangalore National Institute of Siddha (NIS), Chennai Educational institutions National Institute of Homoeopathy (NIH), Kolkata Institute of Post Graduate Teaching & Research in Ayurveda (IPGTRA), Jamnagar (Gujarat) Rashtriya Ayurveda Vidyapeeth (RAV), New Delhi Morarji Desai National Institute of Yoga (MDNIY), New Delhi The Central Council of Indian Medicine (CCIM), New Delhi Statutory organizations The Central Council for Homoeopathy (CCH), New Delhi Manufacturing unit Indian Medicine Pharmaceutical Corporation Ltd. (IMPCL), Almora, Uttarakhand Pharmacopoeial Laboratory for Indian Medicine (PLIM), Ghaziabad, U.P. Laboratories Homoeopathic Pharmacopoeia Laboratory (HPL), Ghaziabad, U.P. Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 7|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II ❖ Herbal drug standardization: WHO and AYUSH guidelines - The term “herbal drugs” denoted by means of plant or part of plants that have been converted into phytopharmaceuticals by simply means of processes involving collection or harvesting, drying and storage. Phytomedicine and phytopharmaceuticals sold as over the counter (OTC) products in modern dosage forms such as tablets, capsules and liquids for oral use. - Herbal drugs are of two types: o Single/ crude drug o Multiple herbal formulations - Single /crude drugs: All mainly whole, fragment or cut plant, plant parts usually dried forms, but sometimes fresh. It also includes algae, fungi and lichen. - Multiple herbal formulations: Formulations are obtained by subjecting herbal ingredients to various manufacturing process such as extraction, distillation, expression, fractions, partition, chromatography and formulations. - “Standardization is a system to ensure that every packet of medicine that is being sold has the correct amount and will induce its therapeutic effect (Chaudhry, 1992).” Standardization of herbal formulations is essential in order to assess of quality drugs, based on the concentration of their active principle, physical, chemical, physicochemical standardization and in vitro, in-vivo parameters. - It is necessary to maintain reproducible efficacy and safety of phytopharmaceutical therefore if phytopharmaceutical have to regard as rational drug should be standardized and pharmaceutical quality must be approved. o Advantages of herbal drugs Low cost of production. They may have fewer side effects. Effective with chronic condition. Wide spread availability. o Disadvantages of herbal drugs Lack of dosage instruction. Poison risk associated with wild herbs. Can interact with other drugs. Inappropriate for many conditions. Some are not safe to use. - Standardization of herbal medicines – concept and scope Standardization of herbal medicines is the process of prescribing a set of standards or inherent characteristics, constant parameters, definitive qualitative and quantitative values that carry an assurance of quality, efficacy, safety and reproducibility. It is the process of developing and agreeing upon technical standards. Specific standards are worked out by experimentation and observations, which would lead to the process of prescribing a set of characteristics exhibited by the particular herbal medicine. Hence standardization is a tool in the quality control process. Several problems not applicable to synthetic drugs often influence the quality of herbal drugs. For instance: 1. Herbal drugs are usually mixtures of many constituents. 2. The active principle(s) is (are), in most cases unknown. 3. Selective analytical methods or reference compounds may not be available commercially. 4. Plant materials are chemically and naturally variable. 5. Chemo-varieties and chemo cultivars exist. 6. The source and quality of the raw material are variable. - Need of Standardization of Herbal drug: Quality control of crude drugs material, plant preparations and finished products. Stability assessment and shelf life. Safety assessment: documentation of safety based on experience or toxicological studies. Assessment of efficacy by ethnomedical information and biological activity evaluations. Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 8|P a g e MPA 204T: Herbal & Cosmetic Analysis (Herbal remedies: Toxicity and Regulations) M. Pharm. (Pharmaceutical Analysis) _ Semester II - The bioactive extract should be standardized on the basis of active principles or major compounds along with the chromatographic fingerprints (TLC, HPTLC, HPLC and GC). The standardization of crude drug materials includes the following steps: 1) Authentication (Stage of collection, parts of the plant collected, regional status, botanical identity like phytomorphology, microscopical and histological analysis, taxonomical identity, etc.) 2) Foreign matter (herbs collected should be free from soil, insect parts or animal excreta, etc.) 3) Organoleptic evaluation (sensory characters – taste, appearance, odour, feel of the drug, etc.) 4) Tissues of diagnostic importance present in the drug powder. 5) Ash values and extractive values. 6) Volatile matter 7) Moisture content determination 8) Chromatographic and spectroscopic evaluation. TLC, HPTLC, HPLC methods will provide qualitative and semi quantitative information about the main active constituents present in the crude drug as chemical markers in the TLC fingerprint evaluation of herbals (FEH). The quality of the drug can also be assessed on the basis of the chromatographic fingerprint. 9) Determination of heavy metals – e.g., cadmium, lead, arsenic, etc. 10) Pesticide residue – WHO and FAO (Food and Agricultural Organization) set limits of pesticides, which are usually present in the herbs. These pesticides are mixed with the herbs during the time of cultivation. Mainly pesticides like DDT, BHC, toxaphene, aldrin cause serious side-effects in human beings if the crude drugs are mixed with these agents. 11) Microbial contamination – usually medicinal plants containing bacteria and molds are coming from soil and atmosphere. Analysis of the limits of E. coli and molds clearly throws light towards the harvesting and production practices. The substance known as Afflatoxins will produce serious side-effects if consumed along with the crude drugs. - Authentication and standardization of herbal raw material: - General protocol for standardized production of herbal drugs Lecture Notes_Dr Sumanta Mondal_GITAM (Deemed to be University) 9|P a g e View publication stats