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Review Article
Ancient wisdom of ayurveda vis-
a-vis contemporary aspect of
materiovigilance
Dhirajsingh Sumersingh Rajput
a
,
*
, R. Galib
b
, V. Kalaiselvan
c
, Syed Ziaur Rahman
d
,
Tanuja Manoj Nesari
b
a
Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy
Anusandhan Bhavan, Janakpuri, New Delhi, India
b
All India Institute of Ayurveda, New Delhi, India
c
Indian Pharmacopoeia Commission, Government of India (Ministry of Health &Family Welfare), Sector 23, Raj Nagar, Ghaziabad, 201002, UP, India
d
Department of Pharmacology, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, 202002, India
article info
Article history:
Received 15 April 2021
Received in revised form
12 May 2022
Accepted 13 May 2022
Available online xxx
Keywords:
Ayurveda
Medical device
Materiovigilance
MvPI
abstract
Materiovigilance is regulatory system to study and follow incidents that might result from using medical
devices. To trail the occurrence of untoward effects associated with medical devices as well as to
document and prevent their recurrence; the Indian Pharmacopeia Commission initiated Materiovigilance
program in India (MvPI) in 2015. Classical texts of Ayurveda include substantial description of devices
intended for various therapeutic purposes such as Panchakarm (penta-bio purification procedures),
Surgeries and for management of gynecological conditions etc. The implemented program of Materi-
ovigilance does not include Ayurveda devices and thus there is need for documentation, systematic
classification of Ayurveda devices and development of Ayurveda Materiovigilance (AMv).
In this review, relevant information from classical texts of Ayurveda, latest published information
related to Materiovigilance and information of medical devices from classical texts of Ayurveda has been
scrutinized along with systematic correlation and applied interpretation of the collected data. It is
observed that Materiovigilance has been well documented in Ayurveda in context of twenty six surgical
and diagnostic devices; eleven mostly utilized pharmaceutical instruments five Panchakarma in-
struments and five home devices. For regulation of quality of Ayurveda medical devices, their
manufacturing, standard utilization, reporting and prevention of medical device associated errors; it is
the need of hour to create and implement regulation in the form of AMv. The Ayurveda literature
highlights that the ancient seers of Ayurveda were well aware regarding Materiovigilance in their own
way. However in view of modern era and mainstreaming of Ayurveda heritage, critical revision, updating,
systematically categorization of Ayurveda devices, development and implementation of AMv regulation
is the need of hour.
©2022 The Authors. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Sciences
and Technology and World Ayurveda Foundation. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
A matter from which something can be created is known as
material [1]. Various types of materials are an integral part of hu-
man civilization since human understood the use of stones for
making crafts. The curious human mind has continued exploring
different materials for creating different kinds of instruments based
on their intellect and thereby fulfilling requirements, from hunting
to personal and social needs till current scenario of industrializa-
tion and advanced technologies. Subsequently, with rapidly
increasing use, along with utilities and advantages, the drawbacks
or harmful effects of these materials were noticed. Such drawbacks
or harmful effects can be divided into two categories, one related to
material itself (harmful effects of the material) and other related to
improper use (incorrect and/or unskilled use). The harmful effects
under the first category mostly occur when an inorganic material
reaches the internal system in human body. For example the
harmful effects observed due to the use of Lead metal for colouring
*Corresponding author.
E-mail: dsrajput.ccras@gmail.com
Peer review under responsibility of Transdisciplinary University, Bangalore.
Contents lists available at ScienceDirect
Journal of Ayurveda and Integrative Medicine
journal homepage: http://elsevier.com/locate/jaim
https://doi.org/10.1016/j.jaim.2022.100593
0975-9476/©2022 The Authors. Published by Elsevier B.V. on behalf of Institute of Transdisciplinary Health Sciences and Technology and World Ayurveda Foundation. This is
an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Journal of Ayurveda and Integrative Medicine 13 (2022) 100593
toys and Lead poisoning [2]. On the other hand the drawbacks due
to second category occur due to inappropriate use of instruments/
equipment prepared from specific materials. These issues has
brought attention of medical community and resulted in imple-
mentation of related regulations such as Medical Device Reporting
(MDR) by United States of America. In India, the Medical Devices
Rule (MDR) was introduced in 2017. As per this rule all the medical
devices used in disease diagnosis, prevention, and treatment etc.
and In vitro diagnostic kits are regulated currently under the
Ministry of Health and Family Welfare, Government of India, and
the Indian Pharmacopoeia Commission (IPC) has also initiated a
program “Materiovigilance”in 2015 [3].
Materiovigilance specifically related to medical devices and the
overall view may represent its beginning in middle of last decade;
however the ancient seers of Ayurveda were considerably aware of
both the aforementioned harmful effects and drawbacks. They set
down the basis of Materiovigilance in Indian System of medicine
(ISM) i.e. Ayurveda, Siddha, Unani and Yoga; Naturopathy and
Homoeopathy. The end period of writing classical text of ISM is
considered till 4th century AD and there is vast difference in
technological development of ISM of that period with the current
time. Therefore the ISM concepts such as Materiovigilance, which
were well understood during that period, are now in need for up
gradation with respect to the current classification system. In other
words, the latest approaches towards categorization and systema-
tization of information has created a need to update the classical
information in a way which fits in this scientific era. In India, the
increasing use of medical devices has highlighted the gaps
regarding precision in monitoring of adverse events associated
with medical device [4]. The IPC, which is designated as National
Coordination Centre - Materiovigilance Programme in India (MvPI)
has created a draft on Materiovigilance [5], however there is no
such documentation where the Ayurveda aspects of Materi-
ovigilance are systematically categorized in comparison to Mate-
riovigilance draft of MvPI. In the view of rules and regulations
imposed on modern medical device manufacturers, the Ayurveda
device manufacturers do not have any specific regulations. The
lacuna's such as systematic classification of Ayurveda devices in
view of MvPI, information of their utility, highlighting the need of
inclusion of pharmaceutical devices, home devices and increasing
awareness regarding AMv, inspired for attempting the current work
on ancient wisdom of Ayurveda vis-
a-vis contemporary aspect of
Materiovigilance which may further exercised in developing Ay-
urveda Materiovigilance (AMv).
This narrative review is based on the classical texts of Ayurveda,
latest published information related to Materiovigilance along with
critical co-relational interpretation of both and summarizing them
systematically in similar way to the draft of MvPI. Information from
Ayurveda classical texts such as Charaka Samhita,Sushruta Samhita,
Ashtanga Sangraha was scrutinized for the data collection as well as
to verify the information narrated in related publications. Addition
of instruments related references from classical texts has been
intentionally avoided as such details are already available [6e8]. In
Ayurveda, other than surgical devices; the devices used for body
purification procedures, drug manufacturing as well as home
utensils are also narrated to have specific effect on human body.
Therefore, all these devices may be included in AMv. The catego-
rization in comparison to MvPI was done based on similarity of
devices as well as intended utilities of respective devices.
2. Correlational aspects
Like other countries, medical devices under the MvPI are
divided into four categories viz. Class A (Low risk), Class B (Low
moderate risk), Class C (Moderate high risk) and Class D (High risk)
based on purposes such as non-invasive, invasive, short term use
and long term use (Table 1)[9]. These categories include surgical as
well several as pharmaceutical materials. However, along with
these categories the two additional categories such as devices used
in Panchakarma (penta-bio purification measures) and home hold
devices can be included in AMv. Twenty six surgical and diagnostic
devices from Sushruta Samhita (excluding count of subtypes)
(Table 2), 11 mostly utilized pharmaceutical instruments (Table 3),
five Panchakarma instruments (Table 4) and 5 home devices
(Table 5) can be included under AMv. The number of devices under
category A, B, C and D are 21, 17, 08 and 01 respectively. It is also
noted that AMv takes account of proper, specific manufacturing of
devices/instruments, their sterilization and sufficient training to
use them (8. Su Ch. 5/3) [10].
There are strong documented proofs of Materiovigilance in ISM
such the Surgical instruments narrated by Sushruta, description
related to health effect of metallic devices used for pharmaceutical
purposes and utensils at home [11]. Almost all surgical devices
narrated in Sushruta Samhita are currently utilized in modern sur-
gery in more or less sophisticatedly developed form. This obser-
vation can be a base for inclusion of AMv under MvPI. It is observed
that the ancient seers of ISM has emphasized on quality of in-
struments as well as quality and training of the physician to handle
the instruments. This fact simply implies the need of inclusion of
training to the concerned physicians who are intended to use the
medical devices. The existing systems MvPI are developed for
synthetic medical devices and medicines and require some modi-
fications to address specific differences for ISM [11 ].
3. Discussion
The vigilance system is a regulation to access information
regarding the use of medical devices or medical products as well as
to assure patients safety in order to increase health benefits.
Pharmacovigilance (PV) is a well-known system for reporting,
management and control of adverse drug reactions due to con-
sumption of medicines. It has been successfully implemented in
Ayurveda since 29 September 2008 [12]. On the other hand,
Materiovigilance is related to only medical devices or the devices
which are used for diagnosis, prevention, monitoring and treat-
mentof diseases. Like PV, implementation of Materiovigilance in
Ayurveda has not been initiated as the ancient instruments now
manufactured in modified forms and now must come under the
Materiovigilance regulation. Since, there is no such claim/clarifi-
cation observed in MvPI draft, it leaves a gap which results in un-
controlled manufacturing and non-recording of data related to
quality and use of Ayurveda medical devices being used in
Ayurveda.
During ancient time, the medical devices belonged to ISM were
not as sophisticated as those similar devices available today.
However, the ancient seers of Ayurveda were well aware regarding
the drawbacks and harmful effects caused by medical devices if
expected qualities, parameters and precautions are not followed
during device manufacturing, processing of medicines and their
use in therapeutics. This perspective of AMv is discussed more
clearly under the following headings.
3.1. Choice of metal
For manufacturing of medical devices, the commonly used
metals and alloys are stainless steel, cobalt-chrome alloy, titanium,
nickel-titanium alloy (nitinol), gold, platinum, silver, iridium,
tantalum, and tungsten [13]. The choice of metal in modern aspect
is based on stability, non-reactivity in acidic and basic mediums;
degradation resistance, durability, dissolution resistance when in
D. Sumersingh Rajput, R. Galib, V. Kalaiselvan et al. Journal of Ayurveda and Integrative Medicine 13 (2022) 100593
2
contact with human body, hardness and specific gravity. In Ayur-
veda, the preference is given to devices prepared from gold fol-
lowed by silver, iron (steel), copper, zinc, tin and lead [14]. The ISM
literature indicates that the first four attributes were considered in
Ayurveda among the aforementioned qualities to choose metal for
manufacturing of medical devices [15]. However the main focus to
choose a specific device prepared from specific metal to treat
specific disease type is based on physiological attributes of patient
(Prakriti) and the aggravated pathological factor (Dosha). This view
is clearly represented in context of use of different metals for
cauterization [16]. Here as per Ayurveda point of view, it can be
interpreted that even precise use of a well manufactured device can
also result in unsatisfactory effects or untoward effect - if the
aforementioned factors are not considered. In other words, AMv
emphasises on consideration of type of metal and its relation with
Dosha.
The specification of MvPI regulations recommends that the
medical devices manufacturing and utilization for intended pur-
poses should not compromise the patients' health [17]. Ayurveda
has also been dedicated for the same purpose. However Ayurveda
health related approach consider almost all common major as well
as minor routine of an individual life such as when to wake up, how
to clean teeth's, how to batch, what and how much meal is to be
taken according to digestive capacity, what should be done after
meal, how to seat, how to walk etc till going to bed. Hence it can be
interpreted that the view of Ayurveda is much more subtle as it
emphasizes controlling health related factors at individual level in
the form of guidelines such as lifestyle, daily regimen and seasonal
regimen (16. Su Ch. 3/3e40) [18]. Similarly the AMv is also made
subtle by including home devices (instruments and equipment)
used for daily purposes such as plates for meal, vessels to store
drinkable water, bath tubs, etc. Few researches have also high-
lighted the health benefits of home devices made from gold, silver
and copper [19,20]. Some of such devices are depicted in Table 5
based in view of AMv. Home equipments are also types of devices
but considering the wide range of home devices, at least the type of
metal for specific purpose can be included in Materiovigilance.
3.2. Device dimension and design
There are no specification details regarding device dimension
and design in MDR 2017. This is because of different types of de-
vices as well as the dependency of dimension and design based on
intended use and preference by physicians. On the other hand,
there is a vivid description of device dimensions and designs in
Ayurveda. Such details are not included in the tables because the
dimensions are narrated in ancient measurements and their stan-
dardization in view of metric measurements is still awaited. Further
the size of instrument (both sharp and blunt) are sometimes out of
context in this modern era and thus such devices may need rede-
signing for utility precision in terms of body control of present time.
For example, the currently used probing device is thin at the blade
as well as shank and slightly thick at the handle; however the
Shalaka (probe) mentioned in Sushruta Samhita for Bhagandara
(fistula in ano) is finer at the tip and gradually increasing in
diameter at the end. This instrument if used as per text may in-
crease risk of perforation and artificial opening. In other words, it
can be claimed that few Ayurveda devices were primitive which
need through revision for replacing them with similar more suit-
able modern devices. Similarly the devices which are out of context
today, can also be identified and discarded to increase precision of
Ayurveda surgical devices as per current need. In modern medicine,
there are an estimated 2 million different kinds of medical devices
on the world market, categorized into more than 7000 generic
devices groups [21]. This observation indicates that there should be
regulations to maintain devise dimension and design as it is almost
impossible to include all devices under Materiovigilance to un-
derstand and maintain record of their risk. In comparison to it, the
classical guidelines for Ayurveda devices are specific and thus can
be reviewed, modified and then included in AMv, which may prove
Table 1
Summarized categories of surgical devices as per MvPI.
Category Criteria for categorization of medical devices based on purpose
Non-Invasive Invasive Short term use Long term use
Class A (Low risk) Medical device which comes into
contact with injured skin, which is
intended to be used as a mechanical
barrier, for compression or for
absorption of exudates only, for
wounds which have not breached the
dermis and can heal by primary
intention.
It is intended for transient use;
and it is not intended to be
connected to an active medical
device; or it is intended to be
connected to a Class A medical
device only
It is intended for use in an oral
cavity as far as the pharynx or in
an ear canal up to the ear drum
or in a nasal cavity; and it is not
liable to be absorbed by the
mucous membrane
e
Class B (Low moderate risk) Medical device which comes into
contact with injured skin, which is
intended to be used principally with
wounds which have breached the
dermis, or is principally intended for
the management of the
microenvironment of a wound
It is intended for use on the
external surface of an eyeball;
or it is liable to be absorbed by
the mucous membrane.
It is intended for short term
use; and it is not intended to be
connected to an active medical
device; or it is intended to be
connected to a Class A medical
device only
It is intended for use in
oral cavity as far as the
pharynx or in an ear
canal up to the ear
drum or in a nasal
cavity; and it is not
liable to be absorbed by
the mucous membrane
Class C (Moderate high risk) Medical device which comes into
contact with injured skin, which is
intended to be used principally with
wounds which have breached the
dermis and cannot heal by primary
intention
If it is intended to have a
biological effect or to be wholly
or mainly absorbed by the
human body, if it is intended for
the administration of any
medicinal product by means of
a delivery system and such
administration is done in a
manner that is potentially
hazardous
eIt is intended for long
term use and, not
intended to be
connected to an active
medical device or it is to
be connected to a Class
A medical device only
Class D (High risk) If it is intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a
defect of the heart or of the central circulatory system through direct contact with these parts of the body
D. Sumersingh Rajput, R. Galib, V. Kalaiselvan et al. Journal of Ayurveda and Integrative Medicine 13 (2022) 100593
3
Table 2
Categories of Ayurveda surgical devices.
Sr. Instrument subtype and total number Category Use
Sanskrit Name (Modern name) Number
1. Svastika yantras (Cruciform instruments) 24 Class A They resemble the mouths of beasts or birds. They are mainly used for extracting thorn
or foreign bodies embedded in bones
2. Sandansha yantras (Dissecting forceps or tongs) 2 Class A The Sandansha yantras are divided into two classes and are with or without locks. They
are used for extracting foreign bodies from skin, muscles, blood vessels and ligaments
3. Tala yantras (Spoon shaped instruments) 2 Class A Tala yantras have one or two surfaces resembling the scale of a fish. They are used for
extracting foreign bodies from the ear, nose or a sinus
4. Nadi yantras (Tubular instruments) 20 Class C Used for removing foreign bodies and inspection and treatment of disease spots of
external orifices. For example, Arsho yantra (rectal speculum for piles), Bhagandara
yantra (rectal speculum for fistula in ano) and Yoni vranekshanam (vaginal speculum)
5. Shalaka yantras (Rod like instruments) 20 Class B Used for different purposes having lengths and circumferences depending on the site of
application. They are used for probing, retraction, separation, extracting foreign bodies
from passages, wound cleaning, cauterization, removing nasal polyps. Applying
collyrium and cleaning urethra
6. Upa yantras (Accessory instruments) 25 Class A These are rope, intertwined thread, bandages, leather straps, bark, creeper, linen cloth,
round pebble, stone, hammer, palm and sole, finger, tongue, teeth, nail, mouth, hair, ring
of a horse's bridle, twig of a tree, spittoon, evacuating, exhilaration, magnetic stone,
caustic, fire cautery and drugs. Mostly useful as supportive accessories during surgery
7. Mandalagra sastra (Circular knife) eClass B Sharp to blunt dissection, Excision and Scrapping,
8. Karapatra (Bone saw) eClass C Used to cut or remove bones, to provide accurate, measurable cuts, e.g. in knee surgery
9. Vrddhipatra (Scalpel) eClass B Used for surgery, anatomical dissection, podiatry etc. Scalpels may be single-use
disposable or re-useable.
10. Nakha sastra (Nail parer) eClass A Paring the fingernails or toenails
11. Mudrika (Ring knife) eClass B Sharp to blunt dissection, Excision and Scrapping,
12. Utpala patra (Lancet) eClass A Used to make punctures, such as a fingerstick, to obtain small blood specimens
13. Ardha dhara (Single edged knife) eClass B Sharp to blunt dissection, Excision and Scrapping,
14. Sucisastra (Suturing needle) eClass B Drainage, puncturing, and suture tissues that are easy to penetrate
15. Kusa patra (Bistoury) eClass B Opening abscesses, slitting up sinuses and fistulas
16. Ati mukha (Hawkbill scissors) eClass B Drainage, to cut soft tissues at the surface or inside the human body
17. Sarari mukha (Scissors) eClass B Drainage, to cut soft tissues at the surface or inside the human body
18. Amtara mukha (Curved bistoury) eClass B Opening abscesses, slitting up sinuses and fistulas
19. Trikurcaka (Three edged knife) eClass B Drainage, to cut soft tissues at the surface or inside the human body
20. Kutharika (Chisel) eClass D A cutting instrument used mainly in orthopedic, ENT and in neurosurgery
21. Vrihi mukha (Trocar) eClass B Puncturing, as a portal for the subsequent placement of other instruments, such as
graspers, scissors, staplers etc.
22. Ara (Awl) eClass C Creating or enlarging holes in bone
23. Vetasa patraka (Scalpel of different type) eClass B Used for surgery, anatomical dissection, podiatry etc. Scalpels may be single-use
disposable or re-useable.
24. Badisa (Sharp hook) eClass C Extraction of foreign bodies, exploration and the manipulation and retraction of tissues,
nerves, vessels, and bone
25. Danta sanku (Tooth scaler) eClass B Extraction of foreign bodies specially used together with periodontal curettes,
periodontal scalers are used to remove calculus from teeth
26. Esani sastra (Sharp probe) eClass C To dissect, incise, separate, or excise tissue, Probing and as a director
*Class A - Low risk, Class B- Low moderate risk, Class C - Moderate high risk, Class D - High risk.
Table 3
Categories of Ayurveda pharmaceutical devices based on the risk parameters.
Sr. Device name(s) Mede up of Risk category*Intended use
1. Mortar and Pestle
(Khalva yantra)
Stone, Iron, Porcelain Class A Trituration/mixing of herbs, metals, minerals, powdering and levigation
2. Crucibles Basically Soil and Iron Class A Melting, extraction, preparing alloys of metals, Processing of mercury
3. Bottles Glass, Silver, Gold, Iron, Soil Class A Kupipakwa kalpa preparation, storage of fermented medicaments
4. Specific Jars Glass, Silver, Gold, Iron, Soil, porcelain Class A Raw drug and prepared medicine storage, for preparation of fermented
medicine
5. Knife Iron, copper, Silver, Gold Class B Cutting plant parts
6. Tula yantra
(weighing
machine)
Iron, copper, Bronze Class A Weighing of medicines and other materials
7. Sieves (according to
particle size)
Wood, Iron, Copper, Cotton Class A Sieving of powdered materials
8. Bhatti (stove/gas
fire)
Mud and Iron Class C Mild, moderate to intense heating
9. Ulukhal yantra
(hammer mill)
Wood, Iron Class A Powdering of dry herbs, pounding of metals
10. Palika yantra (big
spoon with vertical
handle)
Wood, Iron, Copper Class A Formulation preparation from mercury and sulphur, extraction of liquid
from tank, purification of sulphur.
11. Darvi yantra (Big
mouth and long
handle big spoon)
Wood, Iron, Copper Class A Melting and purification of metals
*Class A- Low risk, Class B- Low moderate risk, Class C - Moderate high risk, Class D- High risk.
D. Sumersingh Rajput, R. Galib, V. Kalaiselvan et al. Journal of Ayurveda and Integrative Medicine 13 (2022) 100593
4
a milestone to regulate the uncontrolled manufacturing and sell of
Ayurveda related devices.
3.3. Device quality management and awareness regarding
materiovigilance
Number of potential device-related injuries and potential
device-related deaths registered in 2006 in USA were 116086 and
2830, respectively. However the report shows that only 4146
recall actions were registered from 2000 to 2006 [22]. A survey
conducted in Australia in 2012 reported 6812 incidents involving
medical devices to the Australian Therapeutic Goods Adminis-
tration (TGA) which includes 295 deaths and 2357 serious in-
juries during the period of January 2000 to December 2011.
However, during the same time period, there were only 35
medical device recalls and 34 medical device alerts issued by the
TGA [23]. The overall aspect of these and similar reports high-
lights the concern regarding device quality management and
awareness regarding Materiovigilance. The situation is worri-
some in context of AMv as the guideline for devices is not
established and thus there is no regulation to maintain quality of
Ayurveda medical devices excluding those devices which are
now replaced by modern devices. Another concern is regarding
awareness of Materiovigilance in Ayurveda community. Like PV,
Materiovigilance is neither a part of academic curriculum nor
there is any awareness activity related to it. However, large
numbers of devices are being utilized by Ayurveda practitioners
especially by Ayurveda surgeons, Panchakarma practitioners and
drug manufacturers. The practice of medical devices in Ayurveda
pharmaceutics and therapeutics without sufficient knowledge of
device error; is indicative of critical need to bring forth essential
regulatory measures for Ayurveda devices quality management
as well as competent plans for increasing awareness regarding
Materiovigilance along with AMv aspect.
3.4. Pharmaceutico-materiovigilance (PhMv) and docere-
materiovigilance (DoMv)
The terms PhMv and DoMv are not narrated before and are
designed based on the relation of Materiovigilance to pharmaceu-
tical industry and physician, respectively. The medical devices and
pharmaceutical devices do not require national permissions for
marketing which is must criteria in context of medicine. Medical
devices are controlled under Materiovigilance but there is no control
on the quality of devices used to manufacture medicines by phar-
maceutical industries. Most Ayurveda physicians have mini phar-
macy with necessary devices to prepare the required medicines
themselves. Such common pharmaceutical instruments are depicted
in Table 3 . Medicine manufacturing related regulations of Food and
Drug Administration (FDA) and Good Manufacturing Practices (GMP)
are not applicable for such physicians. Norms such as GMP have strict
regulations regarding several pharmaceutical requirements (e.g. in-
strument, equipment, raw materials, analytical laboratory, packaging
materials etc.) and documentations (e.g. Labels, specifications and
testing procedures, for starting and packaging materials and for
finished product; master formula etc.). However, excluding handling
and cleaning of devices, guidelines regarding type, quality of metal
and its effect on medicine are lacking. In context of drugs for ther-
apeutic emesis and purgation, Charaka, author of Charaka Samhita
has mentioned that factors such as geographical location, season,
devices used for drug processing and storage contributes in phar-
macodynamic action of drug (22. Ka 1/11) [24]. In other words, the
ancient seers of Ayurveda by experience discovered that the in-
struments used for medicine preparation, processing and storage
have synergisticor antagonisticimpact on the attributes of the
medicine. The claim may not be applicable to manufacturing of all
medicines but still it holds ground for manufacturing several Ayur-
veda medicines specially medicines of mercury and fermented
preparations. Therefore, a brief guideline under PhMv can be made
as an update for enhancing precision of GMP.
In Latin, Docero means “Physician”or “Doctor”. The term DoMv
is created to separately emphasize role of physician under Mate-
riovigilance. Keen knowledge of all surgical instruments is also a
must quality of surgeons in Ayurveda surgery too [25]. No matter
how preciously the medical device has been made, the safety of the
device equally depend on user and his purpose of exercise. Here
knowledge regarding types of devices, their use and physicians
training are three key factors to insure safety of medical devices.
Insuring this knowledge and training through specially designed
vigilance questionnaire and initiating mandatory feedback after
purchasing a medical device by a physician is expected under
DoMv. There are over 500,000 different types of devices worldwide
available [26]. The current global market of medical devices is
enormous that the pre-marketing review process is unable to
detect all possible malfunctions, ease and difficulties in use of all
different medical devices [27]. The DoMv will provide data
regarding the benefit of all such devices in clinical evaluations as
well as it may also generate guidelines regarding standard methods
Table 4
Categories of Ayurveda Panchakarma devices based on the risk parameters.
Sr. Device name(s) Mede up of Risk category*Intended use
1. Basti yantra (insertion part of enema tube) Gold, Silver, Copper, Tin, Bronze, Iron, Bone Class B Enema
2. Uttarbasti netra (insertion part of vaginal douche) Iron, Copper, Gold, Bronze, Bamboo Class B Vaginal douche
3. Nadi Swedana yantra (fomentation tube) Iron, Copper, Bronze, Bamboo Class A Whole body fomentation
4. Agni karma shalaka (rods for cauterization) Gold, Silver, Copper, Iron Class C Cauterization at specific part on body
5. Dhuma netra (tube of instrument used for smoking) Gold, Silver, Copper, Iron Class A Smoking of medicated fumes
Table 5
Categories of Ayurveda home useable devices based on the risk parameters.
Sr. Device name(s) Mede up of Risk
category*
Intended use
1. Anjana shalaka
(rods for
application of
Collyrium for eyes)
Gold, Silver,
Copper, Iron
Class C Application of
collyrium at eyes
2. Jivha nirlekhana
(tongue cleaner)
Gold, Silver,
Copper, Tin, Bronze,
Iron
Class A Cleaning tongue
3. Snana patra (vessels
for bath/tub batch)
Copper, Bronze,
Lead, earthen pots
Class A Boiling water and
for bath
4. Udaka patra
(vessels to store
potable water)
Copper, earthen
pots
Class A Storage of boiled
and cooled
drinkable water
5. Bhojana patra
(Utensils for meal)
Gold, Silver,
Copper, Bronze,
Iron, Mud vessels
Class A For storage of food,
plates for taking
meal, glasses for
drinking water
D. Sumersingh Rajput, R. Galib, V. Kalaiselvan et al. Journal of Ayurveda and Integrative Medicine 13 (2022) 100593
5
of handling a device in specific condition/disease. Another advan-
tage of DoMv is that it can serve as a trial unit for approval of de-
vices pre-marketing. Practically accessing advantage, limitations
and drawbacks (potential risk and benefit) of devices can also be
achieved through implementation of DoMv.
3.5. Scope and limitations of AMv
The Ayurveda literature indicates substantial information on
Materiovigilance specially in Sushruta Samhita which is main Ay-
urveda textbook of Surgery. However as a matter of fact, the in-
struments such as Nadi Yantra are now replaced by proctoscope and
gastroscope etc. Similar concepts such as usage of ant for the su-
turing of anastomosed edges of intestines in abdominal surgeries is
indicating towards absorbable suturing material but not the same
can be used in current times. It is also understandable that many
instruments were designed to remove the foreign bodies borne out
of the warfare like arrows, swords, poisonous sticks etc and now
such instruments have limited usages. At the same time, the posi-
tive aspects such as use of disposable instruments made from
specific woods, plant parts, mud and glasses to avoid cross
contamination are appreciable. Establishing quality specification of
such devices is important especially for those which are useable on
daily basis. It is also observed that the AMv aspect in classical texts
of Ayurveda is scattered in different chapters and under different
headings. Thus complete conceptualization of AMv with respect to
MvPI is complicated task. In comparison to global market of mod-
ern devices, the trading of Ayurveda devices is far less and almost
limited to India. However Ayurveda as ISM is serving major health
need in India and recently has attracted attention of medical
community at global platform. The current regulation, which is
under implementation by Government of India (GOI), relates to
grant permission to Ayurveda surgeons to perform 58 surgical
procedures; is a revolutionary amendment [28]. This regulation
may draw attention of device manufacturing industries towards
Ayurveda medical devices and developing their modified forms.
Large numbers of Ayurveda devices specially related to Pan-
chakarma are already in market and there is no guideline to control
their quality standards. The same situation is about pharmaceutical
devices. Elaboration, standardization and implementation of AMv
along with PhMv and DoMv can prove a contributing strategy for
regulation of Ayurveda related devices at pre-market approval and
creating post market vigilance framework.
4. Conclusion
Documentation and regulations for AMv is in undeveloped stage
and there is need and scope for its implementation. Compared to
PV, the awareness regarding Materiovigilance is very much limited
which necessitate to formulate strategies for its implementation.
The information from classical text of Ayurveda highlights satis-
factory awareness towards Materiovigilance, however this aspect
need to be updated systematically for implementation and thereby
betterment and mainstreaming of Ayurveda heritage.
Author credit statement
Dhirajsingh S. Rajput: Conceptualization, Writing - Review &
Editing, Writing-Original draft.
Galib R: Conceptualization, Writing - Review &Editing,
Supervision.
Kalaiselvan V: Writing - Review &Editing, Supervision.
Syed Ziaur Rahman: Writing - Review &Editing, Supervision.
JLN Sastry: Writing - Review &Editing, Supervision.
Tanuja Manoj Nesari: Writing - Review &Editing, Supervision.
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