regulatory aspect of herbal medicines

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  • 1. REGULATORY ASPECT FOR HERBAL MEDICINES Presented by: Vishal ganda M.Pharm (2ndSem.) Parul Institute of Pharmacy Guided by: Mr. Rikin Patel Asst. Professor Parul Institute of Pharmacy 1

2. I N D I A 2 3. HERBAL MEDICINES It Include herbs, herbal materials, herbal preparations and finished herbal products that contain as active ingredients part of plant, or other plant materials or combinations. 3 4. Traditional/ Complementary Medicine -WHO perspective Traditional Medicine Indigenous Medicine existent in the region either recognised or ethnic as in Chinese medicine, Indian Ayurveda, Arabic Unani medicine, African & Latin American practices. Complementary / Alternative Medicine Added or used alternatively to dominant health care system of allopathic medicine as in US, Canada and Europe 4 5. Herbal drug products constitute a major share of all the officially recognized systems of health in India,like Ayurveda, Yoga, Unani, Siddha, Homeopa thy and Naturopathy. Research Councils (ICMR and CSIR), Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) & Drugs and Cosmetics Act 1940 (Amendment) regulates herbal medicines in India. Department of AYUSH, ICMR and CSIR work together to achieve safe, effective AYUSH products for the identified diseases and to develop new drugs. 5 6. Indian Council of Medical Research Founded in 1911 as Indian Research Fund Association Renamed as ICMR in 1949 Apex organization to formulate, conduct, coordinate and promote biomedical research 6 7. ICMRs Research on herbal drugs 1911 onwards - ICMR 1964 70 : Composite Drug Research Scheme 1983 Disease oriented approach 2000 onwards - Collaboration between ICMR & Dept. of AYUSH (earlier ISM & H) Golden Triangle Partnership Program 2005 ICMR NIF Initiative 7 8. Quality Standards of Indian Medicinal Plants Standards set as per WHO guidelines. Use conventional and modern scientific approach. Developed at 4 national laboratories. 3 Volumes. 8 9. MAJOR ACTIVITIES Status Report on propagation techniques of Pterocarpus marsupium, Saraca indica and Streblus asper IHBT, Palampur. Agrotechnology of P. kurroa, IHBT, Palampur Clinical trial with Vijayasar (Pterocarpus marsupium) in Chronic Diabetics Survey of Medicinal plants of Western Ghats 9 10. Spends on Traditional Medicine Development NCCAM, USA USD 123.1 m in 2005 increase by 0.5 % in 2006 WHO - 3 months if there are reports suggesting toxicity when a larger multicentric Phase III trials are subsequently planned based on the results of Phase II study. Adverse Drug Reaction & drug-herb interaction should be reported 13 14. Protocol Group of experts should include experts from traditional systems of medicine. GCP compliant trial design Biostatistician to be involved while designing clinical trial protocol. Pilot studies can be observational Ideal to conduct a randomized, controlled trial to validate Monitoring must to detect toxicity as well as efficacy Statistical analysis should be presented in a manner that is likely to facilitate the interpretation of their clinical importance. 14 15. Monitoring To be based on considerations such as objective, purpose, design, complexity, blinding, size and end points of the trial. To be conducted and documented properly in accordance with GCP. Efficacy to be based on such defined endpoints as, specific clinical symptoms or signs, or defined prognostic laboratory markers. Safety to be monitored on the basis of either symptoms or signs,particularly to end points that may signal anticipated toxicity. Laboratory indicators of liver, kidney, cardiac or haematological toxicity. 15 16. Special Concerns for Herbal Remedies 1)For all researchers GCP Guidelines also pertain to traditional drugs Herbal remedies and medicinal plants to be incorporated in modern system must follow DCGIs guidelines Multidisciplinary Expert group for designing and evaluating the study from concerned systems : ideal for multicentric studies. Association with physicians from the concerned system shall be necessary as co-investigators / collaborators if trial is in Modern Medicine Hospitals 2)Researchers from Indian Systems of Medicine Guidelines not binding for evaluation of traditional drugs for use in their own hospitals / clinics 16 17. QUALITY CONTROL AYURVEDIC DRUGS (Drugs & Cosmetics Act, 1940 & Rules, 1945) Separate Chapter for Ayurveda, Siddha & Unani medicines introduced in Chapter IV A. 33 C - Separate Drug Technical Advisory Board under Drugs & Cosmetics Act, 1940 for Indian Systems of Medicines to advise Government on all aspects related to quality control and drug standardization. 33 D - Separate Drugs Consultative Committee comprising State Drugs Licensing Authorities set up under the Act for securing uniformity in the administration of the Act throughout India 33 E misbranded drugs, 33 EE adulterated drugs, 33EEA spurious drugs. 17 18. IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS ACT, 1940 RELATING TO AYURVEDA, SIDDHA AND UNANI DRUGS 33EEB - Regulation of manufacture for sale of Ayurvedic drugs through drug license system. 33EEC-Prohibitionof manufacture and sale of certain drugs. 33EED Power of Central Government to prohibit manufacture etc., of drugs in public interest. 33 F - Provision for Government Analysts. 33 G - Provision for Inspectors to visit factory. 18 19. 33 H - Penalty for manufacture, sale etc., of drugs in contravention of the Act. 33 J - Penalty for subsequent offences. Prescribe qualifications and duties of the Government analysts. Prescribe methods of testing and analysis. Establish Good Laboratories for Testing and Analysis of drugs. 33 EEB heavy metals within permissible limits - Mandatory testing for heavy metals (Arsenic, Lead, Mercury & Cadmium) in export formulations. 19 20. Permissible Limit of Heavy Metals in ASU Formulations with only Herbal Ingredients As per W.H.O & US F.D.A Lead (Pb) 10 ppm Cadmium (Cd) 0.30 ppm Arsenic (As) 10 ppm Mercury (Hg.) 1 ppm 20 21. List of Approved ASU Drug Testing Laboratories 1)Under Rule -160 A to J of the Drugs and Cosmetics Rule 1945 12 Labs 5 Madhya Pradesh, 4 - Bangalore, 2 - Hyderabad, Chennai, 1 Haryana, New Delhi, Jammu 2)GLP Compliant NABL Accredited Laboratories a. International Institute of Bio-technology (IIBT), Padappai, Tamil Nadu b. Rallis Research Centre, Peenaya, Bangalore, Karnataka c. Jai Research Foundation, VAPI, Gujarat d. Reddys Lab, Hyderabad, Andhra Pradesh 21 22. E U R O P E 22 23. European Community Directives CD 2001/83(basic regulation) CD 2003/63 of 25 June 2003 (Annex I, criteria) CD 2004/24 (Traditional herbal medicinal products) CD 2004/27 of 31 March 2004 (HMPC) 23 24. European Medicines Agency - EMA Central European Authority with specified tasks. Committees and Working Parties Herbal Medicinal Products Committee HMPC Monographs and List Working Party - MLWP Coordination of National Competent Authorities Guidance Documents (www.ema.europa.eu) 24 25. HMPC - Tasks Monographs List entries Scientific opinions Coordination Scientific advice Questions 25 26. Herbal medicinal products fall within the scope of the European Directive 2001/83/EC that foresees marketing of each medicinal product and requires an ad hoc authorisation to be granted on the basis of results of tests and experimentations concerning quality, safety and efficacy. The main features of Directive 2001/EC are traditional herbal medicine definition, simplified registration procedure, provisions for community herbal monographs and community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products(HMPC). 26 27. Most individual herbal medicinal products are licensed nationally by member states, the process for licensing and information of herbal substances and, preparations is harmonised across the European Union. IN United Kingdom, to get a product registered, companies have to submit a dossier to the Medicines and Healthcare products Regulatory Agency (MHRA) demonstrating that it meets the requirements of quality, safety and patient information as per the Traditional Herbal Registration Scheme. The HMPC evaluates scientifically all available information including non-clinical and clinical data but also documented long-standing use and experience in the Community. 27 28. Community monographs are divided into two columns: well-established use (marketing authorisation) and traditional use (simplified registration). Well-established use section describes the safety and efficacy data while traditional use section is accepted on the basis of sufficient safety data and plausible efficacy. The Committee on Herbal Medicinal Products (HMPC) has developed procedure to invite the public to submit scientific data on herbal substances and preparations. The provided information may then be used by the Committee in the development of Community monographs and to Community list entries. 28 29. The European Scientific Cooperative on Phytotherapy (ESCOP) The European Scientific Cooperative on Phytotherapy (ESCOP) was founded in 1989, the main objectives being to establish harmonized criteria for the assessment of phytomedicines, to support scientific research and to contribute to the acceptance of phytotherapy at a European level. In October 1990, the first five monographs were presented at a symposium in Brussels and were officially handed over to representatives of the European Community. After a thorough assessment, the Committee on Proprietary Medicinal Products (CPMP) published four monographs on anthraquinone laxatives in May 1994 29 30. United States of America 30 31. In United States, the term complementary/alternative medicines (CAM) are most commonly used for traditional medicine systems.

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