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REGULATORY ASPECT FOR
HERBAL MEDICINES
Presented by: Vishal ganda M.Pharm (2ndSem.) Parul Institute of Pharmacy
Guided by:
Mr. Rikin PatelAsst. Professor Parul Institute of Pharmacy
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INDIA
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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.
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
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Herbal drug products constitute a major share of all the officially recognized systems of health in India,like Ayurveda, Yoga, Unani, Siddha, Homeopathy 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.
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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
ICMR’s 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 Initiative7
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.
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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
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Spends on Traditional Medicine Development
NCCAM, USA – USD 123.1 m in 2005 increase by 0.5 % in 2006
WHO - <.1 % of budget
India & China spend more
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1980 ICMR Guidelines – “Policy Statement on Ethical Considerations
involved in research on Human Subjects’’
Ethics Committee Informed consent Clinical trials Research on children, mentally
disadvantaged, those with diminished autonomy Traditional Medicine Publications
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Revised ICMR Ethics Guidelines
Released in 2000
All institutions involved in biomedical research involving human beings should follow these guidelines to protect safety and well being of all individuals.
Guidelines on website - http://www.icmr.nic.in
To be legislated - The Biomedical Research on Human Subjects (Promotion and Regulation) Bill, 2006
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Research on herbal drugs – Reverse Pharmacology
No toxicity study to be done for Phase II trials…. if there are no toxicity reports when use is for less than 3 months.
It should be necessary to undertake 4-6 weeks toxicity study in 2 species of animal to be used for > 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
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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.
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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.
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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 DCGI’s 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
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.
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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
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.
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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
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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. Reddy’s Lab, Hyderabad, Andhra Pradesh21
EUROPE
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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)
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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)
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HMPC - Tasks
Monographs List entries Scientific opinions Coordination Scientific advice Questions
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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).
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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.
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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.
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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
United States of America
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In United States, the term complementary/alternative medicines (CAM) are most commonly used for traditional medicine systems.
"Complementary medicine" refers to use of CAM together with conventional medicine, such as using acupuncture, in addition to usual care to help lessen pain.
FDA in its draft guidance “Guidance for industry on complementary and alternative medicine products and regulation by the food and drug administration” clarified different categories of Complimentary Alternative Medicines (CAM) products into cosmetic; device; dietary supplement; drug, as well as "new drug" and "new animal drug;" food; and food additive.
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FDA’s Center for Drug Evaluation and Research (CDER) Guidance for Botanical Drug Products differentiates between those botanical drugs that could be marketed as Over-The-Counter (OTC) and those that would require New Drug Application (NDA).
The current state of herbal research in the United States also contrasts with that of China and Germany. The limited availability of funds (mainly in the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine) greatly restricts the volume of research conducted; thus, in comparison with China and Germany, there is less published US scientific and medical literature regarding herbal use.
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Under DSHEA, the manufacturer or marketer of dietary supplements containing new ingredients is required to notify FDA 75 days before they are marketed.
Under DSHEA, a 7-member Commission on Dietary Supplements was formed to conduct studies and make advisements on the regulation of herbal label claims and statements.
The Office of Dietary Supplements, an office within the National Institutes of Health, was established in 1995 to explore the potential role of supplements for improving health care in the United States.Along with herbs, supplements also include vitamins, minerals, amino acids, homeopathic remedies,concentrates,extracts, and various combinations of these ingredients.
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REFERENCES 1)International journal of herbal medicine.
(www.florajournal.com)
2)WHO Regional Office for the Western Pacific. Guidelines for the Appropriate Use of Herbal Medicines.Manila, Philippines: World Health Organization; 1998.
3)US Food and Drug Administration, Center for Food Safety and Applied Nutrition. Dietary Supplement Health and Education Act of 1994. December 1, 1995. Available at:http://vm.cfsan.fda.gov/~dms/dietsupp.html. Accessed August 14, 2009.
5)Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region.
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