The market is increasing on all fronts. This includes consumer purchases from health food stores, drugstores, grocery stores as well as mass market outlets. Increased demand is reflected in the growth of multilevel marketers; Amway is now selling herbs! So is Shaklee and many others. It is no longer correct to say that they are going mainstream - they are mainstream! When you take aspirin for a headache, you are essentially practicing herbalism in a sense. Why? Aspirin comes from the inner bark of the Willow tree. Obviously, it does not come in the form of a tablet, but there is no denying the relief you obtain from taking it is from the plant derivative of that bark
Despite this damper cast by the recession, the medium to long-term outlook for animal feed industry still remains encouraging, with growth fundamentals such as population, per capita meat consumption, and consumption in developing nations, expected to display resurgence in the upcoming years and drive growth in the post recession period Extending the required impetus to market growth are recent advances in finding more scientific formulations, new molecules, and use of biotechnology, genetically modified organisms (GMOs), and natural/herbal products to enhance animal productivity. Developments in feed manufacturing technology and new feeding concepts also unraveled possibilities to manufacture a range of novel feed additives. Since the ban on antibiotics, livestock producers have been seeking ways to promote animal production and deliver similar benefits offered by antibiotic growth promoters, thus translating into a strong business case for alternative feed additives. animal feed antibiotics/antibacterials market is the largest product segment, having contributed a share of about 27.89% in the total market revenue generated for the year 2009, the animal feed amino acids market is the fastest growing product segment displaying a CAGR of 5.21% over the analysis period 2007-2015.
It is worth to recognize that more than about 25 % of modern pharmaceutical drugs have botanical origins, such as digoxin (drug used to treat congestive heart failure) from foxgloves, tamoxifen (anti estrogenic ) from pacific yew tree ,morphine from poppies, aspirin from willow bark and, and so on…..
First, there is the forthcoming availability of the English translations of the German government's Commission E monographs, to be published by the American Botanical Council. Also, there is the intuition of both standards and therapeutic information monographs from the United States Pharmacopeia, the nation's oldest compiler of standards for medicines, since 1820. There are now 50 therapeutic monographs produced by the Europe Scientific Cooperative on Phytotherapy (ESCOP), an attempt to develop harmonized monographs for leading phytomedicines sold in the European Union. The world Health Organization (WHO) is publishing this year its first 25 monographs which deal with both standards for identity and analysis as well as therapeutic information on 25 medicinal herbs sold world wide. Finally, the new monographs from the American Herbal Pharmacopoeia - particularly the 32-page monograph on St. John's Wort will become a significant contribution to the botanical literature. All these will create a flood of authoritative information that will enable industry to produce better quality herb products and health professionals to use them more effectively.
Clinical Trials In clinical trials teams of physicians carry out studies designed to determine if the drug is safe in people and an effective treatment for the disease in question. Of the 250 compounds that enter preclinical testing, only five will make it this far. There are three phases of clinical trials: Phase I: The medicine is tested in a small group (20-100) of healthy volunteers - often in a hospital setting - to determine its safety profile, including the safe dose range. Pharmacokinetic studies examine how a drug is absorbed, distributed, metabolized and excreted, as well as the duration of its action. Phase I studies can take from six months to one year to complete. Phase II: Placebo-controlled trials involving approximately 100 to 500 volunteer patients who have the disease being studied. The goal of this phase is to establish the &quot;proof of concept&quot; - i.e., the medicine effectively treats the disease. Researchers continue to evaluate the drug's safety and look for side effects, and determine optimal dose strength and schedule (e.g., once or twice daily). Phase II studies can take from six months from one year to complete. Phase III: The medicine is tested in large, randomized, placebo-controlled trials with much larger numbers of patient volunteers - from 1,000 to 5,000, in hospitals, clinics and/or physician offices - to generate statistically significant data. Researchers closely monitor patients at regular interviews to confirm that the drug is effective and identify side effects (also called adverse events). Phase III studies can take from one to four years to complete, depending on the disease, length of the study, and the number of volunteers. While Phase I-III studies are taking place, researchers are also conducting a number of crucial parallel studies: toxicity tests and other long-term safety evaluations; dosage forms; plans for full-scale production; package design; and preparation of the complex application required for FDA approval. Back to top New Drug Application (NDA) Once all three phases of the clinical trials are complete, a company analyzes all of the data. If the findings demonstrate that the experimental medicine is both safe and effective, the company files an NDA with the U.S. Food and Drug Administration (FDA). NDAs typically run 100,000 pages or longer, just one illustration of the extensive testing a medicine must go through in order to gain FDA approval. They contain all of the information about all of the studies - including preclinical testing, all clinical trials, dosing information, manufacturing details and proposed labeling for the new medicine. Back to top FDA Review/Approval In this final stage, the FDA scientists review all the results from all the studies carried out over the years and determine if they show that the medicine is safe and effective enough to be approved. Depending on the medicine or disease in question, the FDA sometimes convenes an Advisory Committee meeting. These independent panels of experts, appointed by the FDA, consider data presented by company representatives and FDA reviewers. Committees then vote on whether the FDA should approve an application, and under what conditions. The FDA is not required to follow the recommendations of the advisory committees, but they often do. If the medicine is approved, or &quot;cleared for marketing,&quot; it becomes available for physicians and patients. It took an average of 16.9 months for the FDA to review each medicine it approved in 2003. The proportion of rejected applications has remained constant over the years at about 10% to 15%. Back to top Manufacturing Following the R&D, and approval stages, manufacturers must build infrastructure and design processes to mass produce the drugs. Construction of manufacturing facilities often has to wait until very late in the research and development process because manufacturers can?t be sure if a particular drug will be approved. If manufacturers choose to use existing facilities, they often need to perform renovations or cut back or eliminate production of other drugs. Engineers and chemists scale-up the fabrication process from the research laboratory level to a mass production level in order to meet the global demand. This process is challenging; facilities must meet strict FDA inspection criteria for Good Manufacturing Practices to ensure high quality control of the product. Once built, the production facilities employ hundreds of highly skilled workers, including engineers, chemists, and quality control technicians. Even the most basic tasks require a more highly trained and technically savvy worker than most other manufacturing industries. Back to top Ongoing Studies Even after approval, the studies and observation continue. A much bigger group of patients may begin to use a medicine upon approval compared with the thousands of patients in clinical trials and in this larger scale rare side effects may occur, so companies must continue to monitor the drug carefully. The FDA requires them to continue to submit periodic reports, including any cases of adverse events (side effects or complications). Sometimes, the FDA requires a company to conduct additional studies. Known as Phase IV or &quot;post-marketing&quot; studies, they evaluate long-term safety or generate more data about how the medicine affects a particular group of patients (e.g., children or the elderly). Phase IV studies can continue for years; one study can cost between $20-30 million. Depending on the findings, a company can use the studies to submit a Supplemental NDA, seeking additional indications for the medicine. Source: www.Innovation.org
Role of Ayurvedic Products in livestock Health and production- A Global Scenario
Role of Ayurvedic Products in livestock Health and production- A Global Scenario Dr (Capt) Tanweer Alam Natural Remedies, India
The comparison of scope! Source: FAOSTAT website Total world population Poultry : 19 Billion Cattle : 1.5 billion Sheep and goat : 1.6 billion Total world population Human: 6.88 Billion
The Market Source: FAOSTAT website & CLFMA REPORT 2009 1.5 Billion USD Total Global Herbal Market 100 Billion USD Total Animal Health Herbal Market
Positive Trend: Across the Segment and Species Digestive Respiratory Dermal Nutrient replacer Stress care
Global Trend of herbal products usage in Animal Health Care <ul><li>Growth Promoters </li></ul><ul><li>Global Feed additive market to grow to $18 billion by 2014 </li></ul><ul><li>Largest contributor is the antibiotic / anti bacterial (28%) and fastest growing is amino acid segment (6%) </li></ul><ul><li>Herbal/ Phytoconstituents based products market is catching up in an impressive manner (20% CAGR) </li></ul>Foodceo.com
<ul><li>Growing Popularity : The Reasons </li></ul>
Growing Credentials: Technical back up available Total number of research papers listed on PubMed containing the word "phytoconstituents."
Growing Credentials: Array of Herbal Monographs <ul><li>Publication and availability of authoritative monographs by various organizations, improving the scientific credibility of herbs. </li></ul>
Indian Herbal Pharmacopoeia British Herbal Pharmacopoeia English Translation of German Commissions E monographs American Herbal Pharmacopoeia ( AHP ) World Health Organization (WHO) Europe Scientific Cooperative on Phytotherapy (ESCOP) United States Pharmacopoeia ( USP ) Confluence of Herbal Pharmacopoeia
<ul><li>Comparatively Less Gestation time of phytodiscovery </li></ul>Growing Credentials: Positive Economics
Pharmaceutical Research and Development (R & D) Process Definitions IND = Investigational New Drug Application FDA = U.S. Food and Drug Administration NDA = New Drug Application Source: www.Innovation.org
Growing Importance <ul><li>Out of 252 drugs considered basic and essential by WHO , 11% are exclusively from plant origin and 28% are of synthetic origin but obtained from natural precursors </li></ul><ul><li>Eighty Five percent (85%) people in deve- loping Countries still rely on traditional medicines as first choice for human health care (WHO). </li></ul>
Advantage India <ul><li>One of the largest flora bio diversity </li></ul><ul><li>75% of the medicinal plants grow naturally in India. </li></ul><ul><li>Good Reservoir of animal species for reconfirming the results and ROI </li></ul>
Example of applications: <ul><li>Role of herbs in treating skin diseases </li></ul>Many results indicate that the concentration of fibers and enzymes (directly/indirectly involved in wound healing) are modulated in treated cases and promoted the wound healing. Ocimum sanctum , Cymbopogon citratus and Andropogon nardus
Shishodia & Pande, 2000 Skin disorders and Ayurvedic medicines Pinus longifollia , Eucalyptus spp. and Cedrus deodara
Conclusion <ul><li>More acceptance of herbal formulation demands more validation and standarization preparedness </li></ul><ul><li>Educating and training the stake holders ( researchers, practitioners etc ) </li></ul><ul><li>Exposing ethno veterinary ,to some extent ,in veterinary course curriculum </li></ul>