Regulatory requirements

1. RRRRRRRRRRRRNJNBKMNLKGR
JSS Academy of Higher Education & Research
(Deemed to be University)
Accredited ‘A’ Grade by NAAC
Sri Shivarathreeshwara Nagara, Mysuru – 570 015
Karnataka, INDIA
REGULATORY
REQUIREMENT FOR
SETTING HERBAL DRUG
INDUSTRY
Prepared by
Ramkishan Jatoth,
PhD Research Scholar,
Dept. Pharmacognosy and Phyto pharmacy
JSS College of Pharmacy, Rockland’s, Ooty-01, Tamil
Nadu, India.

2. GLOBAL MARKETING MANAGEMENT
INTRODUCTION
3
 Medicinal plants (MPs) as a group comprises approx. 9,000 species
and which is around 50% of all the higher flowering plant species of
India.
 More than 15 lakh practitioners use MPs in preventive, promotive and
curative applications.
 There are over 7,800 manufacturing units of herbal product in India
according to Planning Commission, 2000.
 The growing demand for herbal products has led to a big leap in
volume of plant materials traded within and across the countries.
 The EXIM Bank (2003) puts the international market of medicinal
plants related trade as US$ 60 billion per year growing at the rate of
7% only .
 80% of the population of developing countries relies on traditional
medicines, mostly plant drugs, for their primary health care needs
acc.to WHO.

3.  The total value of world herbal trade is currently at USD 120
billion. India exported herbs worth of USD 330.18 Million during
2017-18 with a growth rate of 14.22% over the previous year. Also,
the export of value-added extracts of medicinal herbs / herbal
products during 2017-18 was USD 456.12 Million with a growth
rate of 12.23% over the previous year.
 As per the World Bank Report, world trade in medicinal plants and
related products is expected to be US$ 500 billion by 2050.

4. Demand for medicinal plant in global market
 The wide spread popularity towards the traditional
medicines in Asia, Europe and USA has induced high
growth and development in the world wide trade of
medicinal plant.
 The US market for medicinal plant extract in 1999 was
estimated approximately US$ 500 million which is
equivalent to about 25% of global market.
Global market in herbal medicines was estimated as
fallows-
• In 1994 estimate was US$12.4 billion it was increasing
in up to US$19.6 billion in 1999.
• In 2002 estimate was grow about US$24.2 billion it has
grown up to US$ 62 billion in 2012.

5. Global market in the Herbal medicines estimate in
graphical presentation
12.
4
19.
6
24.
2
6
2
0
1
0
2
0
3
0
7
0
6
0
5
0
4
0
199
4
199
9
200
2
201
2
currency in US$ in
billion
currency in US$ in
billion

6. Indian market
 In India approximately 1800 plant species are use in
AYURVEDA in which
1. 600 species for Siddha.
2. 400 species for Unani.
3. More than 400 species for Homoeopathic.
 A few species are used in Indian pharmaceutical industry for
example –
1. Terpenoids annual turnover US$ 7.7 billion it reach up to
US$ 10.79 billion in 2005
2. Glycoside annual turnover US$ 7.2 billion it reach up to
US$ 10.03 billion in 2005
3. Alkaloid annual turnover US$ 3.6 billion it reach up to US$
5.6 billion in 2005

7. Graphical presentation for some species and annual
turn over
7.
7
7.
2 3.
6
10.7
9
10.0
3
5.6
2
0
1
8
1
6
1
4
1
2
1
0
8
6
4
Terpenoi
d
Glycosid
e
Alkaloi
d
US$ in
billoin US$
in billion

8. BENEFITS OF MEDICINAL PLANTS
4
Different kinds of subsistence, cultural and monetary
benefits are provided by MPs to people.
In China, Nepal and India, they are an important revenue
generating resources and provides income to economically
marginalized and native people.
Medicinal plants can also relax the chronic problem of
global poverty and hunger.
Poverty Reduction Strategy and Programs will require
interventions which are grass roots-based, poor-centered and
livelihood focused.
Medicinal plants can meet the basic needs of the poor rural
people.

9. EMERGING MARKETS
5
 Multinational pharmaceutical companies and domestic manufacturers
of herbal based medicines increased interest had significantly
contributed to the economic growth of the Medicinal plant sector.
 The global market potential of Aloe Vera used to treat burns and
added to skin creams and cosmetics was estimated in the billions of
dollars.
 Devil’s Claw, is a major exports from Namibia for use in the
treatment of arthritis and other inflammatory diseases.
 India is the hub of the regional trade, at national level the 40% of the
state forest-based revenues and 70% of forest export revenues come
from MAPs & on-Timber Forest Products (NTFPs), mostly in
unprocessed and raw forms.
 In Nepal it is estimated that every year 20,000 tons of MAPs worth
US$ 18-20 millions are traded and about 90% of this collection is
exported mainly to India in raw form.

10. DEMAND FOR MEDICINAL PLANTS
From 2002 to 2005 the demand for medicinal plants in India to meet
both domestic and export markets was projected to increase at about
15−16 percent annually.
If properly organized, the cultivation and management of medicinal
plants becomes highly remunerative both in financial and economic
terms for the small-scale growers.
The annual revenue stream from the three major Indian systems of
medicine, is estimated at more than half a billion dollars annually.
In 2000 demand and supply of MAPs was estimated to be about
40,000 to 2,00,000 tons; by 2005 the gap was expected to increase
from 1,52,000 to 4,00,000 tons (Planning Commission, 2000).
 MAP-based industries create employment opportunities in poor, job-
starved states, thereby increasing the cash earnings of local people .

11. GLOBAL MARKETTING OPPORTUNITY
Export opportunities of natural products are remarkable as the world
market is looking towards natural sources for the purposes of
therapeutic use as well as nutritional dietary supplements.
The global herbal remedies market can be classified into five strategic
areas:
(i) Phyto-Pharmaceuticals -the plant based drugs containing isolated pure
active compounds used to treat diseases.
(ii) Medicinal Botanicals /Dietary Supplements -the whole plant or plant-
part extracts used for maintenance of health by affecting a body structure
and its function;
(iii) Nutraceuticals-the food containing supplements from natural
(botanical) sources, that deliver a specific health benefit, including
prevention and treatment of disease;
(iv) Cosmeceuticals-the cosmetic products which contain biologically
active ingredients having an effect on the user and
(v) Herbal raw material.

12. EXPORTS
8
India is one of the major exporters of crude drugs mainly to the 6
developed countries i.e. USA, Germany, France, Switzerland, UK
and Japan and about 75% to 80% of crude drug import market is taken
over by INDIA alone.
Aconite, Aloe, Belladonna, Cassia, Cinchona,Dioscorea, Digitalis,
Ephedra,Ergot,Hyoscyamus,Ipecac,Liquorice,Opium,Podophyllum,Ra
uwolfia, Senna, Stramonium, Isabgol seeds/husk are in chief demand.
The total value of exports of crude drugs has increased from
Rs.394.crores in 1996-97 to Rs.446 crores in 1998-99.
Chinese exports of herbal medicines worth $10 billion a year as
compared to India’s Rs 700 crore showing vast scope of increasing our
advantage to take over large share of the world market.
 Out of the Rs 700 crore exports of herbal medicines, only 40 per cent
is value addition and 60 per cent is export of raw medicinal plants.

13.  Western countries can add value if India is to depend on exports of
raw medicinal plants .
 Neither domestic farmers be ever given better prices nor tribal
people be given more returns for collection of these medicinal plants.
 In India, medicinal plants are registered as a Minor Forest Produce
(MFP) and there is a need to move away from unsustainable
exploitation of forest wealth to contract farming where there is a link
between the producer and the grower for better livelihood.
 It is more worrisome that in crops, which are grown only in India
such as Isabgol, psyllium, there are 848 patents in the last two
decades in the USPTO and only four out of these are by Indians

14. Trading routes of crude drugs
In case of exporting, India is second to China in this ranking with 6,600
medicinal plants

15. IMPORTS
10
All the raw materials used by the Pharmacies are not of indigenous
origin.
Substantial supplies are received from Nepal, Bhutan, Bangladesh,
Pakistan, Afghanistan, Singapore, etc. often through informal
routes.
For instance most of the 'Chiraita' and other Himalayan medicinal
plant crude drugs come from Nepal and Bhutan, 'Oleoresin guggul' of
best quality from Pakistan,Liquorice' from Afghanistan etc.
7, 180 tons raw material demand is met through import According to
the data from CHEMEXCIL, of the total estimated annual demand of
31,780 tons.
The requirements of Akkalkada- Glycyrrhiza glabra(Pakistan, Iran,
Afghanistan),Dalchini-Cinnamomum zeylanica(China),Kankol- Piper
cubeba(Indonesia), Maiphal- Quercus infectoria mostly met through
imports.

16. About 90% requirement of Guggul(Commiphora wightii) is
imported from Pakistan.
Clove (Syzygium aromaticum), Nutmeg mace (Myristica fragrence
aril), Ginger(Zingiber officinale) are the other raw materials partially
imported to fulfill the requirements.
According to a survey conducted by Mac Alpine Thorpe Warrier,
Commonwealth Consultants, (1997), the global market for herbal
products was estimated of US $ 9 billion (Rs.36,000 Crores) which
is expected to grow to US $ 40 billion (Rs.1,60,000 Crores) by 2010.
Of this European market is of the size of US $ 2.7 billion
i.e.,Rs.10,800 crores.
India's share of this market is less than one per cent revealing the fact
that there is substantial scope for the country to exploit this
opportunity.

17. CHALLENGES
 1
Collectors, processors and traders face problems in finding favorable
markets due to price factors, quality and quantity considerations.
Local and regional price fluctuations as well as the lack of current
market and price information affect the income of the actual local
collectors who are dependent on the middlemen or village traders.
Financial and logistic constraints make it difficult for local producers
and collectors to interact more closely with prospective clients .
The followings are the major challenges in trading of Medicinal
Plants both at domestic and international level:
• Inadequate knowledge and incomplete information on products,
markets and prices on the part of collectors/producers.

18. • Lack of standardization and consistency in quality for international
marketing.
• Astringent phyto-sanitary regulations such as requirement of
microbiological test, pesticides and heavy metal test by international
markets.
• Difficult to No proper recognition access appropriate markets and
market information of environmentally and commercially sound MPs.

19. MARKETING STATERGIES
The current increase in the worldwide consumption and use of 'green'
products, especially drugs, flavors and fragrances of natural origin, has
indeed amplified the scope of the use of indigenous flora and collection
& trade of exotic species.
The identification of the ultimate suppliers and buyers is also big issue
in this sector.
The gaps between the producers/collectors and traders or buyers need
to be minimized as these are at present very wide and often
inequitable.
Linkages should be developed in order to have better understanding
about the NTFPs business & between the businesses and the
producers/collectors.
 A holistic management action plan is necessary to formulate for
assessment and management of resource base, best harvesting and
processing practices, trade issues and aspects dealing with the
intellectual property rights on the traditional medicines by the tribal
people.

20. Investments are needed for the development of appropriate
conversation, cultivation harvesting strategies, which will
simultaneously meet the demand for low-cost and locally available
medicines.
At the same time, there must be immediate efforts to ensure the
conservation of diverse biological resources and the preservation and
application of local and cultural knowledge on the use of these resources