Phytopharmaceuticals

A New Drug Class Regulated in India

Dr. Neeraj Tandon

Scientist-G and Head
Medicinal Plants Division
Indian Council of Medical Research
(Ministry of Health & Family Welfare, Govt. of India)
Ansari Nagar, New Delhi 110029

16th May , 2017

 Global Scenario of Botanical Medicines
• Globally, herbal medicine has been considered an important alternative to
modern Allopathic medicine.
• Although the herbal medicines are very popular in the society, only few
medicinal herbs have been scientifically evaluated for their potential in medical
treatment.
• In most countries, the herbal drugs are poorly regulated and are often neither
registered nor controlled by the health authorities.
• The safety of herbal medicines remains a major concern. In the United States,
the FDA has estimated that over 50,000 adverse events are caused by botanical
and other dietary supplements.
• In addition, for most herbal drugs, the efficacy is not proved and the quality is
not assured.
• To address these issues, US-FDA has created a separate guidance document for
botanical products for NDAs and IND submissions - 2004 (first revision Aug 2015)
• Similarly, in India, CDSCO (DCGI) has created a separate guidelines for botanical
products called ‘phytopharmaceutical guidelines’– 2013 (first revision – Nov
2015)
 Herbal medicines
• Herbal medicine products include herbs, herbal materials,
herbal preparations, and finished herbal products containing
parts of plants, other plant materials, or combinations thereof
as active ingredients.
• Herbs include crude plant material, eg. leaves, flowers fruit,
seed and stems.
• Herbal materials include, in addition to herbs, fresh juices,
gums, fixed oils, essential oils, resins and dry powders of
herbs.
• Herbal preparations are the basis for finished herbal products
and may include comminuted or powdered herbal materials,
or extracts, tinctures, and fatty oils of herbal materials.
• Finished products consist of herbal preparations made from
one or more herbs.
 Regulatory scenario

• Regulatory scenario regarding herbal preparations

varies from country to country

• Globally, several diverse regulatory approaches are

in vogue
GLOBAL REGULATIONS
 USA
• US FDA has issued way back in 2000 a
document “Guidance to industry for
Botanical Drugs”.
• As per this, detailed guidelines have been
provided for chemistry, manufacture, quality,
safety and efficacy of botanical origin leads
for approval as drug.
• Such approvals are given by the same FDA
which regulates synthetic drugs.
 China
• In China, the state FDA regulates both synthetic drugs as well as TCM.
• Just like Indian drug regulations, TCM regulations are part of the same
regulatory system.
• Also Chinese regulations recognize and give weightages to history of use
and efficacy for formulations listed in traditional Chinese compendiums.
• However, Chinese regulations have specific regulations that permit
especially processed/fractionated/potentiated Chinese herbal
extracts/leads after review of scientific data for issue of what is called
“Modern TCM Drugs”.
• For Modern TCM Drugs, it is even understood that the IPR protection is
available incase inventive steps exist for the lead which is not specifically
indicated in the traditional Chinese compendiums.
• Artemisinin to treat Malaria, is a classic case of such a drug development
in China which has even secured the Nobel Prize to the inventor from
China.
 South Africa
• It is learnt that South Africa government is considering
to bring in regulations onlines similar to the Indian
“Phytopharmaceuticals as drugs” after the approval of
a South Africa botanical lead by US FDA as a drug.
• It may be recognized that South Africa has a rich
traditional knowledge most of which is oral and
traditional with much less level of documentation as
seen in Ayurveda, Siddha etc. in India.
• Despite this, South Africa is working to bring in
regulations as part of the main drug regulations to
promote traditional knowledge based herbal drugs.
 United Kingdom
• In the UK, as part of the main pharmaceutical
regulations a separate chapter is included for herbal
medicines.
• Herbal medicines are also regulated under “products
under general sale licenses.
• There is no separate dedicated rules yet notified for
botanical drugs where, well characterized botanical
extracts form the lead.
• However, applicants are permitted to apply for such
leads under the same drug regulations that apply to
synthetic drugs – this creates lot of problems which
should be one reason for lack of botanical drugs
approved in the UK.
 Europe
• In Europe, except in Germany where “FITO
therapy regulations permit botanicals as
drugs”, the situation is very similar to the UK.
• However, since the TMP directive has elapsed
it is understood that medicine control agency
of Europe has begun exercise for regulations,
for botanical drugs.
• In fact, this has caused a kind of trade barrier
preventing India Ayurvedic products to be
approved in EU nations.
 Indian Scenerio
In Indian regulations, the major class of Ayurveda, Siddha, or Unani (ASU) drugs
included are
a. Classical ASU drugs as mentioned in the authoritative books of ASU system
drugs, which are manufactured and named in accordance with the formulations
described in the authoritative texts.
For this category, issue of license to manufacture is based on citation in
authoritative books and published literature, unless the drug is meant for a new
indication when proof of effectiveness is required.

a. Patent or proprietary medicine makes use of ingredients referred in the

formulations of authoritative texts but with intellactual intervention, innovation,
or invention to manufacture requires proof of effectiveness, based on the pilot
study as per relevant protocol for ASU drugs.

In 2010, Ministry of Ayurveda, Unani, Siddha, and Homeopathy (AYUSH)

introduced Rule 158 (B) which made the requirement of proof of effectiveness
for licensing of a patent or proprietary ASU medicine. This was followed by the
release of GCP guidelines for voluntary use by the researchers interested in
taking up clinical trials using ASU medicine.
• The government of India has published a draft amendment to Drugs and
Cosmetics Act, and Rules (D & C Act and Rules) on 24th October 2013.
• This creates regulatory provisions of defining phytopharmaceuticals
(botanical-base drugs) and a schedule providing requirements of
scientific data on quality, safety and efficacy to evaluate and marketing
authorization for a plant-based lead as drug on similar lines to synthetic,
chemical moieties.
• In India, it is known that though the new draft regulation was not
present, Guggulu tablets (for treatment of hypercholesterolemia),
Gingko-biloba tablets (to treat liver disorders) have been approved and
marked as drugs by the Central Drugs Standards Control Organization
(Drug Controller General of India)
• However, it is known that approval of Guggulu tablets took a more than
a decade to get this approval as a drug.
• It had required efforts to convince the authorities that several
requirements applicable to a synthetic chemicals were not possible for a
botanical based product.
 Indian Scenerio
 In India, ASU drugs have been under the purview of Ministry of
Ayush.

 In contrast, 2015 regulatory requirements for

phytopharmaceuticals are under the purview of the Central
Drugs Standards Control Organization (CDSCO).

 The gazette notification defines regulatory provisions for

phytopharmaceuticals and regulatory submission requirements
for scientific data on quality, safety and efficacy to evaluate and
permit marketing for an herbal drug on similar lines to synthetic,
chemical moieties.
 Appendix IB

•In Schedule Y, the newly added Appendix IB describes data

to submitted along with the application to conduct clinical
trial or import or manufacture of a phytopharmaceutical
drug in the country.

•The regulatory requirements for NDA for the

phytopharmaceutical drug include standard requirements
for a new drug-safety and pharmacological information,
human studies, and confirmatory clinical trials.
 Phytopharmaceutical drug
 Phytopharmaceutical drug is defined as purified and standardized
fraction with defined minimum four bioactive or phytochemical
compounds (qualitatively and quantitatively assessed) of an extract of a
medicinal plant or its part, for internal or external use of human beings
or animals for diagnosis, treatment, mitigation, or prevention of any
disease or disorder but does not include administration by parenteral
route.

 The new regulation for phytopharmaceutical is in line with regulations in

USA, China, and other countries involving scientific evaluation and data
generation. It does not simply depend on traditional knowledge alone.

 Phytopharmaceutical can be from a botanical (medicinal plant) from any

part of the globe.
 Why Phytopharmaceutical

• This regulation is expected to develop new drugs from

botanicals in a scientific way and would help in the
acceptance of the use of herbal products by modern medical
profession.
• Phytopharmaceutical’s proposal would promote innovations
and development of new drugs from botanicals in a
scientific way, and would give boost to research in drug
development for innovators, industry, and national
laboratories and pharmaceutical research labs in India.
 Scope and Potential

 Complementary/Adjuvant use

 Mainstay Therapy

 Safer alternatives to Synthetic drugs

S. Attributes Products licensed as Ayurvedic Products licensed as new drugs
N medicines made using botanicals (Phyto-pharmaceuticals)
o. as actives
1. Manufacturing As Proprietary Ayurvedic medicine As a new drug whose import of
license/Marketing issued by licensing authority of the marketing is authorized by DCGI
authorization state in which the manufacture is (CDSCO)
undertaken.
2. Number of Can be single or combination of Recommended a
herbs/botanicals more that one with each phytopharmaceutical from a single
ingredient being listed in the botanical to begin with. Combining
authoritative texts of First more than one is not barred but
Schedule or their processed would need a lot more scientific
materials including extracts as data on the rationale, interactions
permitted under Chapter IV-A of and other aspects which are much
DCAR more difficult to generate.
3. Source of the Has to be mentioned in one of the Can be any botanical form any part
Botanical authoritative texts of ayurveda as of Globe.
per first schedule of DCAR
4. Combination with Permitted as per DCAR Not permitted as the definition of
mineral/metel phytopharmaceutical has no
provision
5. Extracts of Extracts of herb as per Chapter IV- Purified/fractionated extracts that
botanicals A applicable to ayurveda meet the definition of phyto-
pharmaceutical and needs to be
supported by scientific data.
• For phytopharmaceutical drug, there is a lot of stress on:

• Available information on the plant, formulation and route of

administration, dosage, therapeutic class for which it is indicated
and the claims to be made for the phytopharmaceutical
• Supportive information from published literature on safety and
efficacy and human or clinical pharmacology information.

• Data generated on:

– Identification, authentication and source of the plant used for
extraction and fraction
– Process for extraction and subsequent fraction and purification
– Formulation details of phytopharmaceutical drug
– Manufacturing process of formulaiton
– Stability data
 Part I (Already known information)
1. Data to be submitted by the applicant
1.1 A brief description or summary of the phytopharmaceutical drug
1.2 Published literature on plant or phytopharmaceutical drug
1.3 Information on any contraindications, side effects
1.4 Published scientific reports on safety and pharmacological studies of phytopharmaceutical
drug
1.5 Present usage of the phytopharmaceutical drug

2. Human or clinical pharmacology information

2.1 Published scientific reports on pharmacological studies including human studies or clinical
studies or epidemiological studies
2.2 Pharmacodynamic information
2.3 Monographs, if any, published on the plant or product or extract or phytopharmaceutical
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI

Part II (data generated by applicant)

Data generated by applicant

3. Identification, authentication and source of plant used for extraction and fractionation
3.1 Taxonomical identity
3.2 Morphological and anatomical description, confirmation of identity and authenticity. (Furnish
certificate of confirmation of botanical identity by a qualified taxonomist)
3.3 Natural habitat and geographical distribution of the plant
3.4 Season or time of collection.
3.5 Source of the plant including its geographical location and season or time of collection.
3.6 A statement indicating whether the species is any of the following, namely endangered or
entitled to special protection under the Biological Diversity Act, 2002 or any known genotypic,
chemotypic and ecotypic variability of species.
3.7. A list of grower or supplier (including names and addresses) and information on the harvest
location; growth conditions; stage of plant growth at harvest; harvesting time; collection,
washing, drying and storage conditions; handling, garbling and transportation; grinding,
pulverizing of the plant material; and sieving for getting uniform particle size of powdered plant
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI

Part II
3.8. Quality specifications, namely foreign matter; total ash; acid insoluble ash; pesticide residue;
heavy metal contamination; microbial load; chromatographic finger print profile with
phytochemical reference marker; assay for bio-active or phytochemical compounds; and
chromatographic fingerprint of a sample as per test method given under quality control of the
phytopharmaceutical drug.

3.9 . An undertaking to supply specimen sample of plant duly labelled and photocopy of the
certificate of identity confirmation issued by a qualified taxonomist along with drawings or
photographs of the diagnostic morphological and histological features of the botanical raw
material used for the confirmation of authenticity.

4. Process for extraction and subsequent fractionation and purification

4.1. Quality specifications and test methods for starting material.
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI
4.2. Steps involved in processing
(a) details of solvent used, extractive values, solvent residue tests or limits, physico-chemical
tests, microbial loads, heavy metal contaminants, chromatographic finger print profile with
phytochemical reference markers, assay for active constituents or characteristic markers, if
active constituents are not known;
(b) characterization of final purified fraction;
(c) data on bio-active constituent of final purified fraction;
(d) information on any excipients or diluents or stabilizer or preservative used, if any.
4.3. Details of packaging of the purified and characterized final product, storage conditions and
labeling.

5. Formulation of phytopharmaceutical drug applied for

5.1. Details of the composition, proportion of the final purified fraction with defined markers of
phytopharmaceutical drug per unit dose, name and proportions of all excipients, stabilisers
and any other agent used and packaging materials.
5.2. Test for identification for the phytopharmaceutical drug.
5.3. Quality specifications for active and inactive phytopharmaceutical chromatographic finger
print profile with phytochemical reference marker and assay of active constituent or
characteristic chemical marker.
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI
6. Manufacturing process of formulation
6.1. The outline of the method of manufacture of the dosage form, along with environmental controls,
in-process quality control tests and limits for acceptance.
6.2. Details of all packaging materials used, packing steps and description of the final packs.
6.3. Finished product’s quality specifications, including tests specific for the dosage form, quality and
chromatographic finger print profile with phytochemical reference marker and assay for active
constituent or characteristic marker, if active constituents are not known.
7. Stability data
7.1. Stability data of the phytopharmaceutical drug described at 4 above, stored at room temperature
at 40 ± 2 °C and humidity at 75% RH ± 5% RH for 0, 1, 2, 3 and 6 months.
7.2 Stability data of the phytopharmaceutical drug in dosage form or formulation stored at room
temperature at 40 ± 2 ° C and humidity at 75% RH ± 5% RH for 0, 1, 2, 3 and 6 months, in the pack
intended for marketing.
8. Safety and pharmacological information
8.1. Data on safety and pharmacological studies to be provided.
8.2. Animal toxicity and safety data:
(a) 28 to 90 days repeat dose oral toxicity on two species of animals;
(b) In-vitro genotoxicity data (Ame’s test and Chromosomal aberration test as per Schedule Y);
(c) dermal toxicity tests for topical use products;
(d) teratogenicity study (only if phytopharmaceutical drug is intended for use during pregnancy).
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI
9. Human studies
9.1. Clinical trials for phytopharmaceutical drugs to be conducted as per applicable rules and guidelines
for new drugs.
9.2. For all phytopharmaceutical drugs, data from phase I (to determine maximum tolerated dose and
associated toxicities) and the protocols shall be submitted prior to performing the studies.
9.3. Data of results of dose finding studies performed and the protocols shall be submitted prior to
performing the studies: Provided that in the case of phytopharmaceutical drug already marketed for
more than five years or where there is adequate published evidence regarding the safety of the
phytopharmaceutical drug, the studies may be abbreviated, modified or relaxed.

10. Confirmatory clinical trials

10.1. Submit protocols for approval for any specific or special safety and efficacy study proposed specific
to the phytopharmaceutical drug.
10.2. Submit proposed protocol for approval for human clinical studies appropriate to generate or
validate safety and efficacy data for the phytopharmaceutical dosage form or product as per
applicable rules and guidelines.
10.3. Submit information on how the quality of the formulation would be maintained during the above
studies.
 IND Filing of Phytopharmaceutical Drugs
Data to be submitted along with application to DCGI
11. Regulatory status
11.1. Status of the phytopharmaceutical drug marketed in any country under any category like functional
food or dietary supplement or as traditional medicine or as an approved drug.

12. Marketing information

12.1. Details of package insert or patient information sheet of the phytopharmaceutical drug to be
marketed.
12.2. Draft of the text for label and carton.

13. Post marketing surveillance (PMS)

13.1. The applicant shall furnish periodic safety update reports every six months for the first two years
after approval the drug is granted.
13.2. For subsequent two years the periodic safety update reports need to be submitted annually.

14. Any other relevant information

Any other relevant information which the applicant considers that it will help in scientific evaluation of
the application.”.
 Possible Advantages in this area
A. New class of drugs would encourage introduction of extensive
evaluation through biomedical sciences, help in the acceptance and
expand use of herbal products by modern medical profession.

B. Across the world, there is a rising interest and demand for plants as a
possible source of therapeutics for unmet medical needs, and this
step would bring this aspiration one step closer to reality.
C. Number of national laboratories in India, scientists groups, and
industrial research and developments (R & Ds) who have been
working on botanical leads can look forward to take this route for
getting marketing permissions.

D. New entrants/investors will get encouraged to invest in this route for

drug development.
 Possible difficulties in this area
• Of the 282 pre-INDs and INDs submitted, only 36% were multiple-plant
combinations, reflecting the difficulties in working with more complex
preparations.

• Of the 282, 113 (40%) were submitted by commercial sponsors; the remaining
169 (60%) were proposed by academic investigators, mostly to conduct small-
scale proof-of-concept studies and without intention to commercialize the
products.

• Despite the increasing IND activity, progress in developing new drugs from
botanicals has been slow, with only two botanical NDA submissions and
approvals to date.

• Possible reasons for the disappointing pace of development include the

“difficulties in characterizing ill-defined mixtures to provide assurance of
quality ” before entering large phase 3 studies, and the “ problematic
translation of unreliable experiences in traditional alternative medicine into
testable hypotheses” that can be applied in modern clinical research
 Botanical Drugs In India
• Gugglip tablets – is perhaps the first drug cleared in
India-Guggul (Commiphora mukul) based-Ethyl acetate
extract-standardized to guggulsterones E & Z, 25 mg/tab,
official in IP, for hypercholesteremia, reduction in Lipid
profile.
• Ginseng Extract capsules – Standardized to
gingkobilobides – for treatment of temporary loss of
memory
• Sylimarin Extract Capsules – to treat liver disorders.
• Ginger capsules – Standardized to 6-gingerols, for
treatment of chemotherapy induced nausea (never
marketed)
 Drugs Approved by US FDA
• In 2004, FDA US created a pathway for drug makers to get
approval of drugs derived from plants.
• In has received about 500 applications, it approved only
two prescription botanical drugs until today.
• First-2006, when the FDA OK’d Veregen (sinecatechins),
an ointment for genital warts that is derived from green
tea leaves. It was developed by Germany’s M/S
Medigene.
• Second-2012, Fulyzaq (crofelemer) is made from the red
sap of the Croton lechleri plant, a South American tree
referred to as the dragon’s blood tree because of its red
latex. A drug marketed by M/S Salix Pharmaceuticals for
the treatment of diarrhea in HIV/AIDS patients who are
on anti-retroviral therapy.
• Dr. Tu Youyou won the Nobel Prize in medicine
for her artemisinin isolated from Artemisia
annua for malaria.

• With the new phytopharmaceutical

regulation, the Indian scientists would
develop noble inventions to discover
phytopharmaceutical drugs for unmet medical
needs.
 Summary
• Introduction of Phytopharmaceuticals as a new class of drug
is an important, timely and progressive step

• It would inculcate higher level of scientific inputs in herb

based products.

• PPh may be specially suitable for mutitarget based diseases

like metabolic syndrome

• PPh may help as a booster dose for the Herb based drug
business.
 Food Safety and Standards Authority of India (FSSAI)
CSIR-IIIM Guidelines for food supplements and neutraceuticals

Food Safety and Standards Regulations 2015 for

• Food or health supplements
Published in Gazette on
• Neutraceuticals
24th November 2016
• Foods for special dietery uses
• Foods for special medical purpose
• Functional foods

Under this guidelines, following ingredients are allowed to be used in foods/

neutraceuticals:

• Plant extracts
• Botanical ingredients
• Vitamins, minerals, trace elements
• Amino acids and other nutrients
• Food additives
• Probiotics
• Prebiotics

Confidential
 FSSAI Guideline: Schedules
CSIR-IIIM
Schedule Content Numbers/ other information
I List of vitamins and minerals and their components 15 vitamins, 15 minerals
(permissible overages provided)
II List of amino acids and other nutrients 11 essential amino acids, 14 non-
essential amino acids, 4 nucleotides
III List of vitamins, minerals and trace elements Vitamins and minerals
allowed to be used in food
IV List of plants or botanical ingredients 400 botanical plants listed (along with
their permitted range for usage)
V List of food additives INS no., name of additive and
a. For health supplements, neutraceuticals permitted level mentioned.
b. for special dietary use
c. for special medical purpose
d. for special medical purpose for weight reduction
e. to be used as GMP level
f. To be used in formats such as tablets, capsules
VI List of ingredients as neutraceuticals List of pure natural products, extracts
(with marker content), and their purity
criteria, permitted range
(187 ingredients listed)
VII List of strains as probiotics (live microbes) 28 microorganisms listed
VIII List of prebiotic compounds Confidential 13 compounds listed
 FSSAI Schedule IV: List of Plants
CSIR-IIIM

This list contains 400 medicinal plants

Plants listed in the Schedule IV shall be used after due processing on in their extracts in
permissible usage range given the table.
Confidential
 FSSAI Schedule VI: List of Ingredients (extracts/ pure NPs)
CSIR-IIIM

This list contains 187 ingredients

Confidential
 Indian Council of Medical Research
Reviews on Indian Medicinal Plants (1–16)

Number of species 4342 Number of References 66364 Number of pages12570

Vol. 1 (Abe-Ale) Vol. 2 (Ali-Ard) Vol. 3 (Are- Vol. 4 (Ba-By) Volume 5 (Ca-Ce) Volume 6 (Ch-Ci) Volume 7 ( Cl -Co) Volume 8 (Cr-Cy)
2004 2004 Azi) 2004 2007 2008 2008 2009
2004

Volume 9 (Da-Dy) Volume 10 (Ec-Ex) Volume 11 (Fa-Gy) Volume 12 (Ha-Hy) Volume 13 (Ib-Ky) Volume 14 (La-Ly) Volume 15 (Ma-Me)
2013 2015 Volume 17 (Mi-My)
2009 2011 2013 2013 2016 2017
 Indian Council of Medical Research
Quality Standards of Indian Medicinal Plants (1–14)
Total monographs - 484

Volume 1 (32 plants) Volume 2 (32 plants) Volume 3 (40 plants) Volume 4 (32 plants) Volume 5 (34 plants) Volume 6 (35 plants)
2003 2004 2005 2006 2008 2008

Volume 7 (34 plants) Volume 8 (35 plants) Volume 9 (35 plants) Volume 10 (35 plants) Volume 11 (35 plants) Volume 12 (35 plants)
2008 2010 2011 2012 2013 2014

Volume 13 (35 plants) Volume 14 (35 plants)

2015 2016
 Phytochemical Reference Standards of
Selected Indian Medicinal Plants

120 PRS

Vol. 1 (2010) Vol. 2 (2012)

30 Monographs
30 Monographs

Vol. 3 (2014) Vol. 4 (2016)

30 Monographs 30 Monographs
Perspectives of Indian Medicinal Plants in
the management of Liver Disorders

CONTENTS
• INTRODUCTION
• AN OVERVIEW OF BIOLOGY OF LIVER
• PERCEPTION OR LIVER DISORDERS
• MANAGEMENT OF LIVER DISORDERS
• MEDICINAL PLANTS AND FORMULATIONS USED
IN LIVER DISORDERS
• MEDICINAL PLANTS USED IN LIVER DISORDERS
AND INVESTIGATED WITH MODERN APPROACH
• METHODS AND PARAMETERS OF
HEPATOPROTECTIVE EVALUATION OF MEDICINAL
PLANTS

41
 Perspectives of Indian Medicinal Plants in
the management of Lymphatic Filariasis
CONTENTS

 INTRODUCTION TO DISEASE

 PLANT DRUGS MENTIONED/ USED/CLAIMED IN

INDIAN SYSTEM OF MEDICINE FOR TREATMENT
OF FILARIASIS

 MEDICINAL PLANTS MENTIONED IN ÄYURVEDA

FOR TREATMENT OF FILARIASIS AND
INVESTIGATED WITH MODERN APPROACH

 MEDICINAL PLANTS USED IN INDIA AND

INVESTIGATED BUT NOT MENTIONED IN
ÄYURVEDA FOR TREATMENT OF FILARIASIS

 DETAILS OF DRUG FORMULATIONS MENTIONED

FOR TREATMENT OF ÇLÉPADA IN ÄYURVEDA

42
Perspectives of Indian Medicinal Plants in the management
of Diabetes Mellitus

CONTENTS

 INTRODUCTION TO DISEASE

 PLANT DRUGS MENTIONED/ USED/CLAIMED IN

INDIAN SYSTEM OF MEDICINE FOR TREATMENT OF
FILARIASIS

 MEDICINAL PLANTS MENTIONED IN ÄYURVEDA

FOR TREATMENT OF FILARIASIS AND INVESTIGATED
WITH MODERN APPROACH

 MEDICINAL PLANTS USED IN INDIA AND

INVESTIGATED BUT NOT MENTIONED IN ÄYURVEDA
FOR TREATMENT OF FILARIASIS

 DETAILS OF DRUG FORMULATIONS MENTIONED

FOR TREATMENT OF ÇLÉPADA IN ÄYURVEDA
Safety Reviews on Selected Indian Medicinal Plants
Thank you…..