Traditional healers and herbal farmers met to discuss regulation and standardization of herbal medicines. The Quality Control and Quality Assurance Laboratory for Herbals aims to test herbal raw materials and finished products to

1. Medicinal Farmers and Traditional Healers Meet
for
Regulation and Standardization of Herbal Drugs
Organised by:
Quality Control and Quality Assurance (QCQA) Laboratory for Herbals
IASST, Paschim Boragaon, Guwahati
Jointly Supported Under:
Phytopharmaceutical Mission for North East India
Department of Biotechnology, Govt. of India

2. Introduction
IASST with partial financial support from DBT has established a quality control and
quality assurance laboratory for testing herbals (raw and finished products). The
state-of-the-art laboratory facility strives to cater to the need of farmers/cultivators,
suppliers and manufacturers of herbals or its products. The facility has applied for
NABL accreditation and State Drug Testing Licence (AYUSH).
The facility will help to produce authentic and quality botanical raw material to user
industries as per global standards.
Plant products with certificate of analysis will have better market value.
The facility will help to produce authenticated drug products.
Ease Export and import issue regarding safety and quality standards.
Avoid Expensive retesting
Facility expert groups would provide support to various problems related to herbal
product processing at NER.

3. Products made from plant (s) or plant
parts that are utilised to treat diseases
or to maintain health by means of
simple process involving harvesting,
drying, processing ,storage etc. It
include in addition to herbs, other
crude plant materials like gum, resins,
balsams, exudates etc.
Herbal Drugs
Herbal
Drugs
Ayurvedic
Medicine
Phytopharm
aceutical
Nutraceutic
al
Dietary
Supplement
Traditional
Medicine
Complemen
tary and
Alternative
Medicine
(CAM)
Herbal
Drugs
Botanical
Phytomedici
ne
Legal Classification of Drugs in India
 Health Foods (FSSAI)
 Nutraceuticals (FSSAI)
 ASU Drugs (AYUSH)
 Phytopharmaceuticals (CDSCO)
 Allopathic Drugs (CDSCO)

4. Worldwide distribution of Herbal
drugs market share
Global herbal medicine market size: USD 230.03 billion in 2021
Europe market size: USD 73.4 billion in 2021
Projected market share by 2028: USD 430 billion
Forecasted CAGR during 2021-2028: 11.32%
Herbal Drugs Industry Facts
Global Herbal Medicine Market

5. Plants sp. (India) Common Name
Glycyrrhiza glabra Liquorice
Aegle marmelos Bael
Plantago ovate (Psyllium husk) Isabgol
Aconitum heterophyllum Atish
Commiphora wightii Guggal
Saussurea lappa Kerth
Picrohiza Kurroa Kutki
Andrographis paniculata kalmegh
Berberis aristata Indian Berry
Tinospora cordifolia Giloe
Swertia chirata Chirata
Emblica officinalis Amla
Santalum album Chandan
Bacopa monnieri Brahmi
Saraca asoca Ashoka
Withania somnifera Ashwagadha
Cassia angustifolia Senna
Embelia ribes Baiberang
Piper longum Long pepper
Nardostachys jatamansi Jatamansi
Gymnema sylvestre Madhunashini
Asparagus racemosus Shatavri
Convolvulus pluricaulis Shankhpushpi
Garcinia indica Kokum
Plants sp. (NER) Common Name
Rauvolfia serpentina Sarpagandha
Coptis teeta Mismi Teeta
Illicium griffithii Star Anise
Hydnocarpus kurzii Tubaraka
Mucuna pruriens BandorKekua
Piper longum Pipli
Swertia chirata Chirata
Taxus baccata English Yew
Boerhaavia diffusa Punrnava
Rubia cordifolia Manjistha
Aegele marmalos Bael
Smilax china Chobcheni
Asparagus racemosus Satmul
Acorus calamus Bach
Curcuma longa Haldi
Saraca asoca Ashoka
Sida cordifolia Bor-sonbarial
Terminalia arjuna Arjun
High demand for medicinal plants in India and NER

6. Export
value
in
million
U.S.
dollars
Export value of ayurvedic and herbal products from
India from financial year 2015 to 2021 (in million U.S.
dollars)
Source: Statistica 2022
Indian Herbal Drugs Industry
AYUSH market key trends and major players
Source: mordorintelligence
 50% of India’s total
plant diversity
 About 1000 plant
species reported as
medicinal plants (Mao,
A.A., 2009; Handique,
P.J., 2009)
Biodiversity hotspots of India
NE states
NE states
NE states
 Total ASU manufacturing units of India: 9482 nos.
 ASU manufacturing units at NER: 48 nos.(0.50%)
 Assam: 44 units, Arunachal Pradesh: 2 units, Sikkim: 2 units,
 GMP compiling ASU units in NER: 5 (?)
ASU manufacturing units in India
Source: Ministry of
AYUSH website

7. Concerns on Herbal Drugs
Critical
observation
about
Herbals
All herbals
are not safe
Mistaken
use of
wrong
herbs
Adulteration
with other
medicine and
chemical
substances
Poor quality
formulations
Innate
toxicity
Interaction
with other
medicine
Incorrect
doses
False
Claims
Misuse by
healthcare
providers/c
onsumers

8. Problems
encountered
during
QA&QC of
Herbals
Phenotypic
and
genotypic
diversity
Chemotypic
Variation
Variation
during post
harvest
care
Method of
Drying
Mode of
drying and
particle size
of
powdered
material
Complex
mixture of
phyto-
constituents
Storage
conditions
Reference
markers
may not be
available
In process
variation
(mode of
extraction,
polarity of
solvents
etc.)
Quality Control and Quality Assurance of Herbals
How to
control it
Standardization
of Herbal Drugs
Standardization refers to the
body of information and
control necessary to product
material of reasonable
consistency. This achieved
through minimizing the
inherent variation of natural
product composition through
quality assurance practices
applied to agricultural and
manufacturing processes.

9. Standardization & quality evaluation of herbal drugs

10.  Research guidelines for evaluating safety and efficacy of herbal medicines
(1993)
 Regulatory situations of herbal medicines-A worldwide review (1998)
 Quality control methods for medicinal plant materials (1998)
 Basic tests for drugs-Pharmaceuticals substances, Medicinal plant materials
and dosage forms (1998)
 General guidelines on methodologies on research and evaluation of Traditional
medicines (2000)
 WHO guidelines for GACP for medicinal plants (2003)
 WHO guidelines for good manufacturing practices (GMP) for herbal medicines
(2005)
 WHO guidelines for assessing quality herbal medicine with reference to
contaminants and residues (2007).
Documents released by WHO on Herbal Drugs

11.  Quality standards of identity, purity and strength of drugs and compliance for
permissible limits of heavy metals, pesticide residue, and microbial load as prescribed in the
respective Pharmacopoeias (ASU&H or IP) are mandatory to follow. These are adopted
from WHO Guidelines for standardization of herbal drugs.
 Compliance to Good Manufacturing Practices (GMP) is mandatory for obtaining
manufacturing license introduced in 2006 in Rule 157 of Drugs & Cosmetics Rules 1945 as
specified in Schedule T.
 Requirement of in house testing laboratories is prescribed under D&C act, Schedule T for
the GMP of ASU manufacturing units. Units not having such facilities are allowed to get their
drugs tested from external NABL approved laboratories.
 Drug Testing Laboratories as approved by Licensing Authorities are considered to take
objective decisions in licensing and quality control matters of ASU drugs.
Current provisions for Quality Assurance of Herbal drugs in India

12. Ministry of
AYUSH
NMPB
Certification
Body
Producer
AYUSH
Certification
Body
Producer
Scope:
Raw Drug
Following:
GAP & GFCP
Scope:
Finished Drug
Following:
GMP
Operational body
Operational body
NABL
NABL
Certification
Certification
Accreditation
Accreditation
Quality Assurance structure of Herbal drugs in India

13. Good Agriculture and Field Collection Practices
 In order to promote medicinal plants sector, Government of India set up National Medicinal Plants
Board (NMPB) on 24th November, 2000 under Ministry of AYUSH.
 Most of the challenges towards development of herbal drugs is due to quality and sustainable
availability of raw materials used in the manufacture of finished products.
 For this, NMPB has prepared India specific guidelines on Good Agriculture Practices (GAPs) and
Good Field Collection Practices (GFCPs) on the pattern of Good Agriculture and Field Collection
Practices (GACPs) developed by the WHO for medicinal plants in 2009.

14. Guidelines on Good Agricultural Practices (GAP) seek to lay down standards for
production of raw material that goes in to the making of the ASU medicines and
standardize the production processes from farm to factory.
Good Agriculture Practices (GAP)
Identification of
cultivated
medicinal plants
Seed and other
propagation
materials
Cultivation Harvest Personal
Botanical authentication
Selection of medicinal plants
Specimen submission
Site Selection
Ecological environment and social impact
Climate
Soil
Irrigation and Drainage
Plant maintenance and protection
Guidelines on GAP of medicinal pants

15. Guidelines on Good Agricultural Practices (GAP) seek to lay down standards for
production of raw material that goes in to the making of the ASU medicines and
standardize the production processes from farm to factory.
Good Field Collection Practices (GFCP)
Post harvest
Processing
Storage and
Transportation
Equipment
Bulk
packaging and
labelling
QA and
Documentation
Inspection and sorting
Primary Processing
Drying
Specific Processing
Processing facilities
Material
Design, construction &
utilisation
Identification
Guidelines on GAP of medicinal pants
Personal
Health, hygiene and
sanitation

16. In order to encourage GAP and GFCP in medicinal plants and enhance quality and safety of
these plants, NMPB, in collaboration with the Quality Council of India (QCI), has launched a
Voluntary Certification Scheme for Medicinal Plant Produce (VCSMPP) in 2010.
Voluntary Certification Scheme for Medicinal Plant Produce (VCSMPP)
The scheme will benefit the medicinal plants producers/collectors/group of
producers/collectors, societies, traders, manufacturers of herbal medicines, Ayush industry
and Ayush consumers due to the assured quality of the medicinal plants/ herbs.
 Reduced risk of recall/rejection.
 Increase buyer confidence in Indian herbs.
 Assured legal compliance.
 Assured sustainable collection
Beneficiaries
Benefits
Certification
process
Registration of
Application Evaluations
at the Site
Testing of
Sample (s)
Grant of
Certificate
Renewal of
Certificate
Market
Sampling
Periodic
Surveillance

17. Medicinal and Aromatic Plants Producer Company (MAPPC) under NMPB
Promotion for organized collection of MAPs in more scientific and sustainable manner
based on required agronomical practices and market demand-based farming cycles.
NMPB is responsible for formation and promotion of MAPPC.
Collectivization of Gatherers / Producers into MAPPC and aggregating their produce for
marketing to address the various challenges faced by the MAP Gatherers / Cultivators.
Purpose of MAPPC
Forward linkages
such as collective
marketing,
processing, market
led MAP production
Backward linkage for
inputs like seeds,
fertilizers, credit,
insurance,
knowledge and
extension services,
Creating infrastructure
for value addition,
primary / secondary
processing
 License for input trade
 Linking MAPPC to financial institutions
 Create platform for direct sale of MAP produce
 Market Linkage for marking of MAPproduce.
Benefits

18. ‘e-charak is a web based mobile app for sale, purchase of Medicinal plants raw
material and it also provide a platform for knowledge sharing and interaction amongst
stakeholders.
In this application and online platform, farmers and collectors could display their
produce in possession & buyers like traders, manufactures, exporters could able to
look into their requirements.
e-charak: Online Market Place of Medicinal Plants

19. Basic Principles of GMP
1. Raw Materials
2. Manufacturing process
3. Quality Control (the manufactured drug is of acceptable quality)
4. Methodology and procedure
5. References and Inspection
Good manufacturing Practices (GMP)

20. Ministry of AYUSH (MoAYUSH), Govt. of India in collaboration with QCI launched
Certification Scheme for AYUSH products for the first time in India in Oct, 2009, which
would make available common AYUSH products in the market with a quality seal
(Standard and Premium).
AYUSH Certification mark (Finished Drug)
Key Highlights
 Through this scheme, drug manufacturers are awarded the quality seal to the
products on the basis of the third-party evaluation of the quality, subject to fulfilment of
the regulatory requirements.
 The AYUSH standard mark is based on compliance to the domestic regulatory
requirements (Ayurvedic Pharmacopeia of India, API).
 AYUSH premium mark is for products moving in international markets.
Option A: is based on GMP requirements based on WHO guidelines and limits of
contaminations
Option B: regulatory requirement of importing countries more stringent than A above

21. Certification Process
Individual manufacturers need to apply to approved Certification Bodies (CBs)
Currently 2 CBs approved
TQ Cert, Hyderabad
IRCLASS, mumbai
Application to be reviewed by CB and competent team nominated
Sample testing for independent testing (3 sample per product)
If testing done in NABL accredited labs, 1 sample per products
Internal QA control and evualtion
Issue of certificate , validity for 3 years
Ministry of AYUSH advisory to prefer AYUSH mark certified
Several states adopted- wi th subsidies for certification costsUP< Odisha, Rajasthan
public purchase policy
Increased public wareness
Current Requrements

22. Under ministry of AYUSH, certificate to be provided by QCI with assessment by
independent bodies like
Centre for Trade Testing and Certification of skilled workers (CTTC)
Voluntary Certification Scheme for Traditional Community Healthcare
Providers (VCS-TCHP)

23. 1. Awareness among the stakeholders is not as expected. It should be give
top priority.
2. Farmers and collector are still apprehensive of getting premium price of the
produce by harnessing certification schemes.
3. There are more than one player on the certification chain such as growers,
primary processor transporter etc,. CBs need to link and partition the cost.
4. Since certification is voluntary at the moment, manufacturers are also not
coming forward aggressively for certified produce.
Challenges towards impletion of the certification schemes

24. PHYTOPHARMACEUTICALS AND TRADIONAL AYURVEDIC MEDICINES
TWO CLASS OF DRUGS