Future of Indian Herbal Industry – Trade-ition Or Trend-ition?
Dr Arun Bhatt MD (Med) FICP (Ind) MFPM (UK)
President
ClinInvent Research Pvt Ltd
Mumbai
arunbhatt@clininvent.com
“If you want to know your past, look into your present conditions.
If you want to know your future, look into your present actions.”
- A Chinese Proverb
“ Nobody can really guarantee the future. The best we can do is size up the chances, calculate
the risks, estimate our ability to deal with them and them make our plans with confidence. “
Henry Ford II
Introduction
Globally, herbal medicine has become an increasingly common form of alternative therapy. A
1997 survey estimated that 12.1 percent of adults in the United States had used an herbal
medicine in the previous 12 months (as compared with 2.5 percent in 1990). 1 Annual sales of
herbal drugs are approximately $3 billion in Germany and $1.5 billion in the US. Greater
acceptance of herbal medicine may be attributed to increased appreciation of products termed
"organic" and "all natural"; disenchantment with traditional medicine because of its inability to
cure everything; fewer side effects perceived or observed with many gentle herbal remedies; and
the relatively low cost of herbal products.[1]
In the US, pharmaceutical companies are generally not interested in funding clinical trials.
However, in Germany, where herbal products are widely used, the German Federal Health
Agency formed Commission E, a group of reputable scientists and practitioners with a mission to
collect data on the safety and efficacy of commonly prescribed herbs. More than 300 monographs
have been completed to date, and English translations are expected to be made available in 1998
by the American Botanical Council in Austin, Texas.
In the US, the Dietary Supplement Health and Education Act of 1994 established a federal
framework for the regulation of product labeling and information about dietary supplements.
Dietary supplements are, for the first time, specifically defined to include vitamins, minerals, herbs
and other botanicals, amino acids, and other dietary substances used to supplement the diet. [2]
The act also allows product labeling to contain a statement describing how the product's
consumption effects "structure or function" or general well-being in humans. However, it does not
permit a manufacturer to make a specific health claim for a product. The product label must carry
the disclaimer: "This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease." [3] The total quantity
of all ingredients and the phrase "dietary supplement" must also be included on all labels.
Clinical trials that have been designed to test currently used herbal preparations are laborious,
time-consuming, and costly, and it is understandable why many herbal preparations on the
market do not go through rigorous testing procedures.
Nonetheless, many consumers have turned away from conventional medicines, believing that
"natural"—though untested—substances such as herbs are safer than synthetic substances.
Batch-to-batch variability, however, is a significant problem with herbal preparations. Companies
that produce these preparations generally do not employ rigid quality controls, do not have
adequate personnel or standards, and do not evaluate their products for purity and reliability.
Contradictory pharmacologic effects have also been reported as a result of herbal preparations
containing different subspecies of plants or having alterations in the chemical composition of
active ingredients. Because herbal preparations are usually not evaluated for purity and
consistency of active compounds, they often contain accidental contaminants, such as allergens,
pollen, mold, and mold spores.[4] In addition, some herbs are edible when immature but
poisonous at maturity.
In general, side effects from herbal products are minimal. Many consumers are entranced by the
designation "all natural" and thus tend to believe that all herbal products are safe. They do not
think of herbs as drugs. The consumer should be advised by providers of medicinal herbs to
observe the proper dosage recommendations and stop taking the herbal product if any adverse
effects occur. Other concerns regarding herbals involve their use by pregnant or nursing mothers
and by young children and infants. There is not much information on drug (herb)-drug
interactions, so people taking prescription medications should be cautious. The Botanical Safety
Handbook published by the American Herbal Products Association contains labeling
recommendations for 700 herbs commonly used in the US.
A provider of herbal medicines should ask a consumer the following questions:
Have you used this product before?
Are you allergic to any plant products?
Is this product for personal use or for someone else, such as a child or elderly patient?
Are you pregnant or breast-feeding?
Are you aware of the importance of closely following label instructions for dosages and duration
of use?
Are you taking prescription or nonprescription medications intended for the same purpose as this
herb?
Alternative medicine is hitting the US like a storm. Sales of herbal medications now exceed $1.5
billion a year and are increasing annually by about 25%. While herbal products have been used in
other countries for many years, their popularity in the US has grown dramatically within the last 6
years. Consumers here are seeking alternative therapies to supplement modern conventional
medicine. There are approximately 250,000 plant species in the world; of these, nearly 1800 are
available for use in the US. This article reviews indications, dosing, side effects, and drug
interactions of 4 of the big sellers—Echinacea, garlic, Ginkgo biloba, and ginseng. Herbal
medicine is big business. Long popular in many parts of the world, its use has increased
dramatically in the US in recent years. Product sales now number in the billions of dollars and are
increasing by about 25% annually. Heightened interest in herbal remedies has also spurred
controlled scientific research into their efficacy and safety. In Part 2 of their article, the
investigators review the indications, dosing, side effects, and possible drug interactions of 2 of the
top sellers—St. John's wort and saw palmetto.
(Muller JL, Clauson KA Top Herbal Products Encountered in Drug Information Requests (Part 1)
Drug Benefit Trends 1998 10:43-50)
Among the first drugs for treatment of high blood pressure was reserpine from the herb Rauwolfia
serpentina, described many centuries ago in Indian Ayruvedic monographs. Indeed, some of our
most important drugs, while not originating as CAM therapies, are derivatives of the active
ingredients identified in herbal remedies. Such drugs of botanical origin include digitalis for the
treatment of congestive heart failure and vincristine, and more recently, taxol, for treatment of
cancers. There are indications that other herbal remedies and CAM practices may prove effective
in preventing and treating chronic diseases, possibly reducing the costs of healthcare, as well as
advancing our understanding of how healing works. At present, however, few of these practices
have been tested for safety and effectiveness. Still others await discovery and validation of their
worth.
The Past : Tradition to Trade-ition
For example, after visiting the Central Institute of Research in Indigenous Systems of Medicine at
Jamnagar on 2nd November 1955, Pandit Jawaharlal Nehru had observed – ‘a
fascinating inquiry is going on in this research institute and it may well
lead to very fruitful results. The only right approach has to be one of
Science, that is, of experiment, trial and error. In whatever type of
medicine we may deal with, we cannot profit by its study unless we
apply the method of science. Nothing should be taken for granted.
Everything should be tested and proved and then it becomes a part of
scientific medicine – old and new.’ Unfortunately this message, which
was given almost 50 years ago, has been lost somewhere.
Market
The total European over the counter market for homoeopathy was £590m in 1991, compared with
£1.45bn for herbal medicines
Size & Growth of Market for ISM
Market Size
Ayurvedic medicines
Homeopathic medicines
Siddha medicines
Unani medicines
Previous 3 year CAGR
Estimated market growth
In Million
Rs. 35,000 US$ 824
Rs. 6,000 US$ 141
Rs.
50 US$ 1.17
Rs. 1,000 US$ 23.5
12-15%
15-20%
According to the World Health Organisation estimates, the present demand for medicinal plants is
about US $14 billion a year and projected demand by the year 2050 is US$5 trillion. Medicinal
plant related trade in India is estimated to be around Rs.550 crores per year. While the value of
global trade in medicinal plants has been put at over $60 billion per year, Indians total turnover of
Rs. 2300 crores of Ayurvedic and herbal products, major over-the-counter (OTC) products
contribute around Rs.1200 crores.
Other formulations fetch around Rs.650 crores. And classical Ayurvedic formulations contribute
the remaining Rs. 450 crores. With world demand growing at 1% annually, the export market for
medicinal plants appears to be growing faster than the Indian domestic market.
The Rs 4,000 crore (Rs 40 billion) Indian herbal drug market, which is split between ethical -- that
is, drugs that require a doctor's prescription -- and over the counter drugs, is growing by over 15
per cent a year against the compounded annual growth rate of around 8-9 per cent reported by
the Rs 20,000 crore (Rs 200 billion) allopathic drugs market.
Globally, the herbal medicine market is valued at around $60 billion, half of it in Europe alone.
Small beer when compared with the $400 billion allopathic drugs market.
Most observers say that Indian companies will first launch ethical herbal drugs in India, and will
later develop new drugs, focus on exports and try to conquer the world -- a prescription followed
by their allopathic counterparts in India.
Regulatory Trends
EC directive 65/65 on proprietary medicinal products has considerably constrained product
licences for herbal medicines.28 Concern at the possible carcinogenic effects of pyrolizidine
alkaloids, which occur in a number of medicinal herbs, most importantly comfrey (Symphytum
officinale), has recently prompted both the German and British governments to restrict the
availability of these herbs. The case of comfrey highlights a regulatory problem--the plant is
common in many European countries and is sometimes taken as a tea or vegetable: should it
therefore be viewed as a food or as a medicine? This problem remains unresolved; the European
Court of Justice has had to adjudicate on whether vitamins and herbal medicines are foods or
medicines (cases 227/82 and 369/88).
Medical views
Surveys of doctors' attitudes to complementary medicine show that, overall, physicians believe it
is moderately effective, but low response rates make some studies unreliable. Although hospital
doctors and older general practitioners tend to be more sceptical than younger doctors and
medical students, most respondents believe that some of the more established forms are of
benefit and should be available on the NHS. Younger doctors and medical students are more
likely to perceive their knowledge of complementary medicine as inadequate and to want more
tuition in the subject.
Qualitative research shows that many doctors want to be supportive of patients' choices and
would welcome further information, although they generally regard complementary therapies as
scientifically unproved. Doctors' concerns about such therapies include whether they are used as
an adjunct or an alternative to conventional care, how effective conventional treatments are in the
given condition, and the possibility of adverse effects.
(Zollman C, Vickers A . ABC of complementary medicine Complementary medicine and the
doctor BMJ 1999;319:1558-1561)
BACKGROUND: Complementary (or alternative) medicine has become a prevalent phenomenon
in most industrialized countries. At present the evidence from randomized controlled trials
investigating its effectiveness is fragmentary and therefore inconclusive. OBJECTIVE: To assess
whether physicians perceive complementary medicine as useful and/or effective. METHOD: A
literature search was performed to retrieve all relevant articles. Twelve surveys addressing this
question were found and analyzed by evaluating perceived usefulness and/or effectiveness.
RESULTS: The results show a remarkable variability between surveys. On average physicians
perceive complementary medicine as moderately effective--the rating was 46 +/- 18 on a scale of
0 to 100 points. Young physicians seem to judge complementary medicine more optimistically
than their more seasoned colleagues. There is no trend to suggest that complementary medicine
is increasingly perceived as useful and/or effective. The data do not answer the question whether
physicians view complementary medicine as a nonspecific powerful placebo or as specifically
effective. CONCLUSION: Complementary medicine may be useful; however, the notion urgently
needs to be tested in randomized controlled trials.(Ernst E, Resch KL, White AR. Complementary
medicine. What physicians think of it: a meta-analysis. Arch Intern Med 1995 155:2405-8)
Percentage of public reporting use of complementary medicine
---------------------------------------------------------------------------------------------------Any form of
Manipulation
Phytotherapy
complementary
(including osteopathy
or
Country
medicine Acupuncture Homoeopathy and chiropractic) herbalism
---------------------------------------------------------------------------------------------------Belgium
31
19
56
19
31
Denmark
23.2
12
28
23
ND
France
49
21
32
7
12
Germany
46
ND
ND
ND
ND
Netherlands
20
16
31
ND
ND
Sweden
25
12
15
48
ND
United Kingdom
26
16
16
36
24
United States
34
3
3
30
9
---------------------------------------------------------------------------------------------------ND = data not available.
(Fisher P, Ward A Medicine in Europe: Complementary medicine in Europe BMJ 1994;309:107111 (9 July)
Quality
Results A total of 14 (20%) of 70 HMPs (95% confidence interval, 11%-31%) contained heavy
metals: lead (n = 13; median concentration, 40 µg/g; range, 5-37 000), mercury (n = 6; median
concentration, 20 225 µg/g; range, 28-104 000), and/or arsenic (n = 6; median concentration, 430
µg/g; range, 37-8130). If taken as recommended by the manufacturers, each of these 14 could
result in heavy metal intakes above published regulatory standards.
Conclusions One of 5 Ayurvedic HMPs produced in South Asia and available in Boston South
Asian grocery stores contains potentially harmful levels of lead, mercury, and/or arsenic. Users of
Ayurvedic medicine may be at risk for heavy metal toxicity, and testing of Ayurvedic HMPs for
toxic heavy metals should be mandatory.
(Saper RB, Kales SN, Paquin J, Burns MJ, Eisenberg DM, Davis RB, Phillips RS Heavy Metal
Content of Ayurvedic Herbal Medicine Products JAMA. 2004;292:2868-2873).
The growing popularity of traditional Indian remedies necessitates a critical evaluation of risks
associated with their use. This systematic review aims at summarising all available data relating
to the heavy metal content in such remedies. Computerised literature searches were carried out
to identify all articles with original data on this subject. Fifteen case reports and six case series
were found. Their collective results suggest that heavy metals, particularly lead, have been a
regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to
patients taking such remedies. The incidence of heavy metal contamination is not known, but one
study shows that 64% of samples collected in India contained significant amounts of lead (64%
mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of
heavy metal content in traditional Indian remedies and motivate us to consider means of
protecting consumers from such risks.
(Ernst E. Heavy metals in traditional Indian remedies Eur J Clin Pharmacol 2002 57:891-6)
It is only fair to emphasize that the heavy metal content of traditional remedies is not solely a
problem of traditional Chinese remedies. Indian traditional medicines 29 and remedies from the
Middle East32 and South America33 have also been implicated. It is therefore important that
regulatory measures aimed at minimizing the risks associated with such traditional treatments are
not exclusively targeted at TCMs. (Ernst E, Thompson Coon J Heavy metals in traditional
Chinese medicines: A systematic review Clin Pharm Therap 2001 70)
Clinical Use
A Cautionary Tale …
Placebo
10.3
Imipramine
12.0
St. John's Wart
13.4
Figure 2 indicates the promise of St. John's wort as an antidepressant in a study showing that it
compares favorably with a standard anti-depressant, imipramine, and that both are significantly
better than placebo (9) …
…However, Figure 3 indicates that if St. John's wort is taken by subjects who are also taking
indinavir, an HIV protease inhibitor, levels of indinavir in the blood are reduced below the level
required to block HIV multiplication. RESEARCH
The Clinical Imperative. The extensive use of untested CAM practices by the public dictates that
NCCAM make clinical research (15) its highest priority and the centerpiece of its research
portfolio. In this regard, the Center's approach differs significantly from that of the other NIH
Institutes and Centers where the emphasis is on the discovery of new knowledge through basic
research. In contrast CAM consumers and healthcare practitioners want to know now whether
available options are safe and effective. Thus, while essential basic information will be sought in
parallel, NCCAM is committed to the clinical study of promising CAM substances and modalities
before knowledge becomes available about their active ingredients, mechanisms of action,
stability, and bioavailability.
To help identify fertile areas for clinical investigation and the appropriate level of investment in
these areas, the Center relies on evidence-based reviews (described in Appendix VI). These
analyses indicate that information regarding the efficacy and safety of CAM therapies spans a
continuum ranging from anecdotes and case studies through encouraging data derived from
small, well-developed Phase I and II clinical trials (Table 1).
Basic Science Research. While clinical research is the centerpiece of NCCAM's research
portfolio, NCCAM will pursue basic studies in parallel. The realization that herbals are not single
agents but mixtures of many compounds makes our understanding of their underlying
mechanisms of action all the more critical. Moreover, research projects such as those designed to
understand the neurobiological basis for acupuncture-mediated analgesia and the essential
components of St. John's wort that ameliorate depression may contribute to the knowledge base
of conventional biomedical researchers and inspire novel treatment approaches and rational drug
discovery. To take full advantage of the opportunities to build a base of CAM-related basic
science discoveries, randomized clinical trials will be designed not only to test treatments, but
also, to the extent possible, to determine underlying mechanisms of action, discover biomarkers,
define pharmacokinetics, identify the active components in natural products, and collect data on
the natural presentation and progression of the diseases under study. For example, NCCAM's
current trial of Ginkgo biloba not only will test whether this ancient natural product delays the
onset and progression of dementia, but the trial also represents the single largest prospective
study of intellectual decline in aging Americans to date.
Collaboration. The efficiency with which we advance our research agenda will be enhanced by
leveraging the resources and expertise of our colleagues in other NIH Institutes and Centers,
other government agencies, (19) research institutions, the academic and international
communities, and industry. The opportunities for such collaborations are abundant and it is
gratifying that we have already found many partners at NIH and other agencies, and that centers
of excellence throughout the world have expressed interest in working with us. ( Expanding
Horizons Of Healthcare National Center For Complementary And Alternative Medicine Five-Year
Strategic Plan 2001-2005 September 25, 2000 )
Traditional Chinese Medicine
Traditional Chinese Medicines may be less affected than the pharmaceutical industry by WTO
accession. Competition from other countries will place pressure on domestic producers, but this is
expected to have a beneficial effect in forcing the restructuring of the TCM industry, where no
manufacturer controls more than 10 percent of the market and there is no dominant player. This
will include establishing a scientific basis for the efficacy of herbal medicines, which is imperative
if China is to develop medicines that conform to international standards of quality.
To increase competitiveness and market share, many domestic TCM industries have introduced
new medicines and increased the technology content of their products, transforming their
products from traditional forms of powder, mass and small pills into capsules, tablets, syrup.
Following WTO membership, the government has decided to nurture its own large
pharmaceutical companies, particularly those producing Traditional Medicines, while reducing the
number of small companies. This is intended to boost the quality of Chinese medicine and
enhance China's ability to compete in world markets. The government is also promoting
business-to-business e-commerce as a way of developing a nation-wide pharmaceutical
marketing network.
Over-the-counter sales have recorded very high growth in recent years, while retail outlets have
moved in the direction of large-scale and chained operation. Expecting increased competition
from foreign players, major local retail companies have embarked on aggressive expansion
programs to seize the market before it completely opens. To cope with the expected rise in
competition from foreign players, the Chinese government reportedly plans to groom five to ten
mega distribution enterprises with annual turnover amounting to $500 million, and 40 regional
distribution enterprises with annual turnover amounting to $250 million within the next three to five
years.
The limited scientific evidence about TM/CAM’s safety and efficacy as well as other
considerations make it important for governments to:
Formulate national policy and regulation for the proper use of TM/CAM and its integration into
national health care systems in line with the provisions of the WHO strategies on Traditional
Medicines;
Establish regulatory mechanisms to control the safety and quality of products and of TM/CAM
practice;
Create awareness about safe and effective TM/CAM therapies among the public and consumers;
Cultivate and conserve medicinal plants to ensure their sustainable use.
Suggestions
An earlier Exim bank study, finds renewed world wide interest in natural medicines
and newer cases in food and cosmetic industries, with good prospects for exports of
medicinal plants from India. A favourable policy framework is required to promote
commercial cultivation, research and development, and increased exports of
medicinal plants. The study adds that exports of finished products, rather than of
crude material, should be encouraged
What is urgently required is the change in attitude of scientists, traditional practitioners and
industry on one hand and the special policy initiatives by the Government on the other. Then only
can we create the golden triangle of traditional machine, modern machine and modern science.
On Building a Golden Triangle between Traditional Medicine, Modern Medicine and Modern
Science
Dr. R. A. Mashelkar, FRS
Director General, CSIR &
Secretary to Govt. of India
Department of Scientific & Industrial
Research
New Delhi
25th May, 2003
References
1 De Smet PAGM Herbal Remedies N Engl J Med 2002 347: 2046-56