CHALLENGES AND ISSUES RELATED TO REGULATION OF TRADITIONAL MEDICINE

Prof. Dr. K. R. Kohli Director of Ayurveda, Maharashtra

TRADITIONAL MEDICINE
The sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observation handed down from generation to generation, whether verbally or in writing.
y y y y y

Ayurveda Yoga & Naturopathy Unani Siddha Homeopathy

POSSIBLE REGULATORY CATEGORIES FOR HERBAL MEDICINES

1. Prescription

medicines: medicines/drugs that can only be purchased with a prescription (i.e. a physicians order). In some countries, the legal framework allows traditional practitioners to prescribe medicines. the counter medicines: medicines/drugs that can be purchased without a prescription from a physician.

2. Over

3. Self

medication only: medicines/drugs permitted for self medication purposes only.

POSSIBLE REGULATORY CATEGORIES FOR HERBAL MEDICINES

4.

Dietary supplements: A dietary supplement is a substance which contains, for instance, a vitamin, a mineral, a herb or other botanical or an amino acid. A dietary supplement may be intended to increase the total daily intake of a concentrate, metabolite, constituent, extract or combination of these ingredients. Health food: health foods could be products that are presented with specific health claims and therefore regulated differently from other foods. Functional foods: like health foods, functional foods may be products which are offered with specific health claims and therefore regulated differently from other foods.

5.

6.

NEED OF DIFFERENTIATION BETWEEN

Ayurvedic Products
1. Based on sound fundamental principles, well documented 2. Time tested on human beings for safety & efficacy 3. Based on wholesome ingredients 4. Simple procedures of processing and manufacturing 5. Holistic and comprehensive approach of use for health

Herbal Products
1. Emperical and Experimental base 2. Products based on in-vivo and in-vitro trials 3. Isolated or extracted material is used 4. Sophisticated procedures for new molecules 5. Generalized or Empirical use

Contd

NEED OF DIFFERENTIATION BETWEEN

Ayurvedic Products
6. The product is developed and tested in the manner it is used

Vs. Herbal Products

6. The product is developed and tested on the basis of analytical parameters 7. No such consideration, fragmented approach of treatment

7. Psychophysical characteristics of patients are taken into consideration, hence holistic approach

REGULATION/REGISTRATION OF TRADITIONAL MEDICINES

MEMBER STATES REPORTING HAVING REGULATIONS OR LAWS GOVERNING HERBAL MEDICINES

TYPE OF LAW OR REGULATION ON HERBAL MEDICINES

MANUFACTURING: REGULATORY REQUIREMENTS

REGULATORY STRUCTURES
y

The regulatory structure governing ASU products in India is divided between the regulation of the products themselves and the regulation of the institutions which either train the personnel in charge of training doctors in AYUSH, or are concerned with delivery of AYUSH healthcare or in some cases, both. Chapter IV A of the Drugs and Cosmetics Act, 1940 (the Act) governs these products and they are defined in the Act as including all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani (Tibb) systems of medicine specified in the First Schedule to the Act.

REGULATORY STRUCTURES
y

Though the Act classifies AYUSH products as medicinal products for regulatory convenience (regulating manufacture on a commercial scale as well as regulating sale through pharmacies against a prescription), many of these products are not only used as medicines, but also as food supplements, or health foods, or OTC products. However, the effect of the legislation is that any product which is manufactured for commercial sale without a license as required under the Act is not an AYUSH product.

TECHNICAL IMPLEMENTATION / ENFORCEMENT RELATED EVALUATION OF AYUSH MEDICINES

y

Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB which advises the government on drug related issues) Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC which advises the government on implementation issues) State licensing authorities who actually look after the testing process of AYUSH drugs to ascertain their purity, safety etc.

Manufacturing Process
In India Schedule M of the Drugs and Cosmetics Act includes the Good Manufacturing Practices that are applicable to the pharmaceutical industry and these have come into effect from the 1st of July, 2005

WHY REGULATION?
1. 2. 3. 4.

Growing Popularity Newer Communities using the TMs Increase in the awareness Availability of sophisticated equipments & Laboratory equipments. Use of toxic substances and metals in traditions Depleting RM resources & fear of adulterations and adjustments. Concerns on Safety of the medications of TMs.

5. 6. 7.

WHY REGULATION?
8.

9. 10. 11. 12.

Multiplicity of usages as Food, Diet Supplement, Medicine etc. Variety of prescribers: from a Natural traditional healer to Degree holders. Owing to very low literacy levels, many quacks make inroads into practice of Ayurvedic and Herbal medicine. Uncontrolled advertising and a greed to make quick buck(MUSLI POWER). Unethical practices like adulteration of products with western medicines, peddling of products with no therapeutic benefits, making unsubstantiated medicinal claims.

WHY REGULATE ?
Protect Protect

consumer interests unsubstantiated product claims product integrity- evaluation parameters

Maintain Ensure

requisite standards batch to batch consistency public safety not compromised toxicities

Are safe, effective, beneficial Products, practices lead to positive clinical outcomes.

TRADITIONAL MEDICINE REGULATION: CHALLENGESCHALLENGES-1

1. Traditional medicines & practices being adopted by newer populations
2.

International diversity: Traditional medicine practices have been adopted in different cultures and regions without the parallel advance of international standards and methods for evaluation. National policy and regulation: Not many countries have national policies for traditional medicine. Regulating traditional medicine products, practices and practitioners is difficult due to variations in definitions and categorizations of traditional medicine therapies. A single herbal product could be defined as either a food, a dietary supplement or an herbal medicine, depending on the country.This disparity in regulations at the national level has implications for international access and distribution of products.

3.

TRADITIONAL MEDICINE REGULATION: CHALLENGESCHALLENGES-2

y

Safety, effectiveness and quality: Scientific evidence from tests done to evaluate the safety and effectiveness of traditional medicine products and practices is limited. While evidence shows that acupuncture, some herbal medicines and some manual therapies (e.g. massage) are effective for specific conditions, further study of products and practices is needed. Requirements and methods for research and evaluation are complex. For example, it can be difficult to assess the quality of finished herbal products. The safety, effectiveness and quality of finished herbal medicine products depend on the quality of their source materials (which can include hundreds of natural constituents), and how elements are handled through production processes.

TRADITIONAL MEDICINE REGULATION:CHALLENGESREGULATION:CHALLENGES-3

Knowledge and sustainability: Herbal materials for products are collected from wild plant populations and cultivated medicinal plants. The expanding herbal product market could drive over-harvesting of plants and threaten biodiversity. Poorly managed collection and cultivation practices could lead to the extinction of endangered plant species and the destruction of natural resources. Efforts to preserve both plant populations and knowledge on how to use them for medicinal purposes is needed to sustain traditional medicine. Patient safety and use: Many people believe that because medicines are herbal (natural) or traditional they are safe (or carry no risk for harm). However, traditional medicines and practices can cause harmful, adverse reactions if the product or therapy is of poor quality, or it is taken inappropriately or in conjunction with other medicines. Increased patient awareness about safe usage is important, as well as more training, collaboration and communication among providers of traditional and other medicines.

CHALLENGES RELATED TO THE REGULATORY CONTROL OF TRADITIONAL MEDICINES 1. 2. Brand Names: Differences in Opinion of approving brand names in different states. Lack of interest in Implementation of rules and regulations by state regulatory authorities (Examplesamples of Ayurvedic/herbal medicines contain heavy metals, steroids.. etc.) Shortage of staff due to less importance being given to Regulation Leniency in punishing the Guilty of bypassing the rules(Lethargy or Corruption??) The widespread use of multi level marketing for alternative therapies is an additional ethical challenge.

3. 4. 5.

ASSESSMENT OF SAFETY AND EFFICACY

y

Lack of education/ information leads to believe that Traditional drugs are safe, but there are certain herbs which causes adverse effect on the body e.g. Chitrak , Bhallatak. Adverse drug reactions of the drugs are not recorded properly (Pharmacovigilance) Most of the manufacturers are not interested in evaluation of safety and efficacy of the herbal medicines. (not ready to spend time & money on quality) Each product may contain several different plants and potentially hundreds of chemical constituents, some of which may be present in very low concentrations; these factors combine to make laboratory investigation both complicated and expensive. Infrastructure for testing safety of the drugs is not adequate Inadequacy of trained staff for evaluation of safety of herbal drugs

y y

ISSUES ON QUALITY CONTROL OF HERBAL MEDICINES

1.

The source and quality of the raw material are variable.

2.

The methods of harvesting, drying, storage, transportation, and processing (for example, mode of extraction and polarity of the extracting solvent, instability of constituents, etc.) have an effect.

ISSUES ON QUALITY CONTROL OF HERBAL MEDICINES

1.

Lack of adequate studies to prove safety of many of the traditional medicinal categories like Herbomineral preparations, poisonous plants etc. Lack of Price control mechanism. Lack of adequate data on resourcing of the RM Complexity of traditional drugs; metals with minerals, minerals with herbs, metals, minerals & herbs, Animal material, Herbs alone The widespread use of multi level marketing for alternative therapies is an additional ethical challenge.

2. 3. 4.

5.

PHARMACOPOEIA COMMISSION FOR INDIAN SYSTEM OF MEDICINE

Govt. of India has published standards on 540 single drugs and 101 compound formulation. Still there are about 2000 single drugs and about equal number of compounded formulation where standards are to be developed. The emphasis on limiting undesirable impurities in bulk drugs and formulations. There is fast progress in evolution of more and more sophisticated methods of analysis. These rapid developments should be reflected in successive editions of pharmacopoeia which must per force be brought out more frequently than it is done at present. A well organized independent body may be able to assure this, and furthermore the standards embodies in monographs can be fully unbiased.

Stronger pharmacovigilence
y y y y

A stronger pharmacovigilence by AYUSH department needs to be implemented. Knowledge of existence of Pharmacovigilence and its role to be made popular. Act not only at the time of problem but make a habit of making it as routine. Atleast start incentivising companies for Clinical Trials & Phase IV studies

ISSUES RELATED TO MEDICINES PREPARED BY

TM PRACTITIONER
GMP

registration is mandatory for industry but exemption has been given to registered ayurvedic practitioner and teaching institutions that prepare medicines for their patients. is no system available to check quality of the herbal medicines prepared by Vaidyas or the Institutions. are occasions when self made medicines contain heavy metal, mixtures of synthetic drugs, steroids etc. reactions owing to the use of such drugs are usually not communicated to the regulatory authorities.

There

There

Adverse

RECOMMENDATIONS
There

is a strong need to hasten the process of preparing Ayurvedic pharmacopoeia for established drugs and constituents.

Quality

assurance is a significant demand of AYUSH importers and should help in establishing credibility of AYUSH products. Therefore, a quality certification for AYUSH products exported from India would establish quality credentials of these products, and is strongly recommended. (AYUSH & QCI)

IMPORTANT PROVISIONS OF INDIAN DRUGS & COSMETICS ACT RELATING TO AYURVEDIC MEDICINES Stringent and Quick Penalty for manufacture/sale of drugs in contravention of the Act. Penalty for subsequent offences needs to be more severe. Availability of specific analysts for traditional products. Standardize methods of testing and analysis. Establish and rope in more Laboratories for Testing and Analysis of Drugs Schedule - E of Drug Act prescribe list of poisonous material used in ASU drugs require special safeguards

WHO PERCEIVES CHALLENGES IN REGULATION

y

According to the WHO global survey on the national policy and regulation of TM, common difficulties and challenges in regulation: 1. Lack of information sharing 2. Lack of safety 3. Monitoring for herbal medicines 4. Lack of methods to evaluate their safety and efficacy

RECOMMENDATIONS OF THE WHO COMMITTEE

Member States should:
1.

Work to strengthen the regional network in all possible aspects of herbal medicines, particularly with regard to their safety, efficacy and ADR; Develop and strengthen herbal medicine education and training, practice and research; Work at facilitating harmonization among those countries that have common systems of herbal medicine

2.

3.

RECOMMENDATIONS OF THE WHO COMMITTEE

Member States should:
4.

Establish a national advisory committee for herbal medicines Adopt requirements for the registration of herbal medicines. Establish coordination agencies to implement GACP; Establish an ADR monitoring centre and system for conventional medicines and herbal medicines, and develop necessary linkages with other ADR monitoring centers in the Region and with WHO collaborating centers;

5.

6. 7.

DRUG MAGIC REMEDIES ACT.

A strong implementation of the Magic Remedies Act (MRA) needs to be done for AYUSH products right from the point of providing license by the state FDAs to monitoring marketing of these products. Rampant use of herbal medicines is done today by offering cure for diseases like cancer, HIV etc.

TEACH REGULATORY NORMS IN CIRRICULUM

y

REGULATIONS FOR MANUFACTURING, SALES, QUALITY CONTROL ETC AND THE VARIOUS LAWS SHOULD BE TAUGHT AT THE GRADUATION/POST GRADUATION LEVEL OF THE AYUSH CIRRICULUM. THIS INFORMATION WILL LEAD TO DEVELOPING BETTER AND RESPONSIBLE PRACTITIONERS TO SERVE THE SOCIETY.

GMP Implementation for AYUSH products

Implementation of GMP to AYUSH manufacturing is a real challenge due to varied reasons ranging from Raw materials, to process standardization, testing methods etc. A separate and unique method needs to be developed for implementation of Schedule M for AYUSH products manufacturing .

Use of AYUSH medicines by the unorganised sector

y

Rampant use of AYUSH medicines is done in the unorganised market by quacks, retail shops selling these medicines. Need strict regulations on these but the challenge is its fall back on the popularity of such medicines and non availability issues. Education through mass media discouraging such practices needs to be done.

Lack of price control mechanism

Unlike the DPCO (Drug Price Control Order) for pharmaceutical preparations, absence of any such order makes the whole business of manufacturing and selling AYUSH products a money making business without any control on the quality. y A simple oil used for relieving pain of Arthritis could thus be sold at Rs. 1200.00 for a bottle of 100 ml.
y

REGULATION: A CONTINUOUS NEED BASED PROCESS

Notification dated July 9, 2008 to allow use of excipients, additives, preservatives, anti-oxidants, coloring agents, flavouring agents, alternate sweeteners permitted in the Indian Pharmacopoeia/Prevention of Food Adulteration Act, 1954 (NEW) Notification GSR NO.893(E) of 170 Guidelines for evaluation of Ay. Siddha & Unani Drugs. Grant of Ayurvedic licenses to soaps, shampoos, hair tonics and antacid products(New) Clarification with regarding to use of prefix and suffix in classical and patent ASU medicines.(New) Supplementary guidelines for manufacturing of Rasaushadhies/ Rasamarunthukal / Kushtajat (Herbo-mineral-metallic compounds).

AYUSH MARK VOLUNTARY CERTIFICATE SCHEME (VCS) FOR AYUSH PRODUCTS The scheme has been started since Oct, 2009, which has two levels of certification an AYUSH Standard Mark for meeting for domestic regulatory requirement and an AYUSH Premium Mark for meeting international norms such as those set by WHO or regulation of importing countries.This will go under an independent third party assessment system and would result in Quality seal being awarded. Till now 125 Premium Marks and 95 Standard Marks has been awarded to ASU products.

WAY FORWARD
REGULATION IS A CONTINUOUS PROCESS WHICH WILL KEEP ASKING FOR MORE

T H A N K Y O U