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Conceptual Study…

5. AUSHADHA SAVIRYATA AVADHI

In the previous chapter detailed description of concept of samskara has been


carried out with emphasis on sthitisthapakatva. In this chapter application of this
sthitisthapakatva property in the field of medicine is being hypothetically postulated.
Etymological Derivation:
Sthitisthapakatava word is made up of two terms sthiti is first and sthapakatva
is second of them. Both these terms originate from stha dhatu. Word sthiti is derived
from root stha – tishthati.

- , - |
Various meanings of stha dhatu are to stay, to abide, to remain, to be, to
occupy, to establish,
Sthiti means remaining, staying and so on. Word sthapaka means one who stays,
stands, retains, maintains.

( .) |
Thus word meaning of sthitisthapakatva is one which is responsible to
maintain sthiti i.e. stay, continue etc. i.e. continuing its sthiti, maintaining its state.

| -- |
Concept of Sthitisthapakatva:
An attempt to understand Sthitisthapakatva guna from Ayurvedic perspective
is being done here. Ayurveda believes in panchamahabhuta siddhanta and has limited
itself to level of panchamahabhuta for understanding various mechanisms involved in
all things. Sthiti denotes a condition of a dravya. Actually from Ayurveda point of
view no dravya is stable but it always undergoes minute changes constantly. The
magnitude of change is so small that it is not perceived instantly and over the period
of time after a considerable amount of change happens then only one can perceive it.
E.g. Increase in height and weight of a small baby increases daily minutely which not
recognizable as the magnitude of change is less and changes are very slow. Another
example can be colour of building will be fresh when it is new but over the period of
time it will become dull. This change is not all of a sudden but daily and slowly and
hence difficult to perceive. When these changes adopt a large scale then they are
perceived.

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Next question is if these changes are unavoidable then is there any fixed
pattern of these changes and if yes then what? Answer to this question is provided by
Charaka as

| . . . /!"
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1, / 2 3 2 #4 ) . 1, #4 )5 678, 6 79 & : . ; | --
; < ) = > .= =
+? @ | ; 2 AB
These changes are chakravat i.e. cyclical. They start from avyakta and go on
to manifest and after manifestation it reverts back to avyaktata. This cyclic chain of
events goes on and it does not have any starting or end point.
Figure 1 Showing Schematic Representation of Changes happening in dravyas

Avyakta Vyakta

In this chapter sthitisthapakatva of aushadhi dravyas is considered so


avyaktata and vyaktata are dealt in this aspect. Among the pancha mahabhutas
akasha, vayu, agni, jala and prithvi gradual increase is seen in vyaktata wherein
akasha is avyaktatama which with gradual increase in vyaktata and simultaneously
decrease in avyakatata gets converted in prithvi which is vyaktatama. One important
law of physics to be remembered here is ‘matter can neither be created nor be
destroyed but can only be transformed from one form to another’. Here onwards these
changes will be referred as transformation. Charaka’s version of avyaktata to
vyaktata is supported by Vaidika reference from Taitareya Upanishad wherein similar
quotation is available as

C < D C < EF E G% |E < 5) H H) I : B| J.K.

In case of vyakta to avyakta this transformation is in reverse order i.e. prithvi


transforms in jala, jala in agni so on and finally akasha in atma. This cycle of avyakta

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to vyakta i.e. from akasha to prithvi mahabhuta and vice versa takes place
continuously in all dravyas and it is nishpratyanika means irresistible. This
transformation from vyakta to avyakta is termed as pralaya and vice versa is called
srishti. This cycle is continuous same can be explained in a schematic manner as
Figure 2 Showing Schematic Representation of Transformation of mahabhutas

Once it is clear that such transformations (karya) happen and are ineluctable;
then immediate question arising in one’s mind is what are reasons (karana) behind
these continuous transformations? These karanas may be present in the dravya itself
which is undergoing transformation or may be those which are different (prithak)
from this dravya. These karanas can be classified into two subtypes based on their
ashraya.
i. Tad dravya ashrita - Internal factors present in a dravya
ii. Tad dravya anashrita - External factors influencing the dravya

Internal factors:
In case of aushadhi dravyas by applying panchabhautika siddhanta of
Ayurveda; these factors must and should be among pancha mahabhutas. They may be
mahabhutas themselves or gunakarmas which reside in them. Among the five
mahabhutas transformation let it be physical or chemical is a karma attributed to
Agni mahabhuta. As Ayurveda believes that all dravyas are panchabhautika it will be
fraction of agni mahabhuta present in this drug which will be responsible for these
transformations. More the fraction of agni mahabhuta will be active in a dravya more
will be quantum of these transformations. E.g.- In sharira pitta has mahabhuta
predominance of agni this is the reason why pitta prakriti person will have early
digestion which is reflected by repeated abhyavarana. This feature has been explained

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by Charaka as dandashuka. This agni mahabhuta predominance manifest as vali


palitya khalitya at level of dhatus whereas as krodhadhikya at psychological level.
Applying the same logic in aushadhi dravyas which possess predominance of agni
mahabhuta will be more vulnerable for such transformations.
After thinking about role of agni mahabhuta in these transformations it is also
necessary to evaluate role of remaining mahabhutas. Akasha mahabhuta has been
attributed with apratighata karma which can be understood as non hindrance and as it
is avyakta it is unlikely to play active role in these transformations. Akasha will
provide ashraya for these changes and will not oppose these changes because of its
nishkriyarta.
Vayu mahabhuta has been attributed with karma of vibhajana. It has been
discussed in previous chapter that samyoga and vibhaga are always associated to each
other. Thus vayu mahabhuta is responsible for samyoga and vibhaga which are
impossible without movement, this movement is attributed to chala guna of vayu
mahabhuta. Vayu has a synonym as agnisakha which clearly indicate towards its
association and active role in fascinating/fastening karmas of agni mahabhuta. Thus
aushadhi dravyas which have predominance of agni and vayu mahabhuta will be
vulnerable to these transformations.
On the contrary jala mahabhuta has complete antagonistic properties as that of
agni mahabhuta and will not be helpful to agni mahabhuta for pachana karma. In
fact jala mahabhuta by virtue of its gunakarmas will oppose the karmas of agni
mahabhuta and slow down these transformations. Bandhana karma attributed to jala
mahabhuta also opposes the chalana karma of vayu mahabhuta.
Prithvi mahabhuta has murtatva as its main karma which is attributed to its
khara guna by virtue of which it provides a firm structural base to a dravya. Guru,
ruksha, kathina, sandra etc gunas of prithvi mahabhuta oppose the action of agni
mahabhuta and may be helpful in resisting these transformations in a drug.
After discussing mahabhuta pradhanya and its role in these transformations it
should be also kept in to mind that mutual configurations of these mahabhutas are of
innumerable types and they also play an equally important role in deciding the final
outline of dravya i.e. guna karmas of it. Thus not only composition (conjugation) but
configuration of mahabhutas is also to be taken in consideration while deciding the
mahabhuta pradhanya of a drug.

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External factors:
After reviewing the factors responsible for transformation in a drug it is time
now to consider factors outside the drug. These may be again pancha mahabhutas
along with desha and kala. Role of pancha mahabhutas has been already explained in
internal factors and similar effect of these as external factors is anticipated. Coming
to desha and kala, kala is considered as a factor which influences the desha also.
Explanation of kala itself will include desha in it. Kala is a vibhu and nitya bhava.
Kala in other words has been quoted as parinama. This definition of kala signifies its
role in bringing changes in all other dravyas in universe. Because of this karma of
parinamana kala is called as karana of bhutas.

. )2 KL || . .% /MN
.5 # --- )5O P Q 9 # $% 0R )2 15 S/
S/ )2T )= B = 50 #6. UV ' )2W &P & (1|| . . .% M/N

Kala will invariably affect everything and it is not possible to eliminate this effect
completely which has been explained by Charaka as

.T )2 S) P
: XS |)5+ Y $ Z[ Y$ 5 \ ; || . . / ]

Word used by Charaka is nishpratikriya which means these changes cannot be


resisted. In case of the drugs also, effect of kala is difficult to avoid but can be
curtailed up to a certain extent with help of different samyogas and samskaras. This is
the aim of Ayurveda which has been narrated by Charaka in first adhyaya as
Dirghanjivitiya. At the same time it is to taken into consideration that it is not mere
prolonging of life span but in a hitkara as well as sukhkara way. This is why concept
of sadvritta, swasthavrita, dinacharya, rutucharya, rasayana chikitsa are the main
stakes of Ayurvediya chikitsa vijnana. Modern medicine has recognised Geriatrics as
a separate branch recently and is yet in early developing stages but Ayurveda has
recognised it before few thousand years and devoted a separate branch among its
eight sub divisions called Jara tantra.
Among the three avasthas of vaya balya, tarunya and vardhakya, tarunya is
considered as the best and hence all the efforts are made to protect and preserve
sharira in tarunya which is the most desired as well as best period of human life. Not
only in Ayurveda but in various other sciences such as yoga, dehavedha in

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rasashastra also desire at the same. Alchemy developed in various countries are also
an effort on the same lines.
Applying this to the concept of medicines it is to be understood that same
efforts were also made for maintaining the effective span of a medicine i.e. protecting
and prolonging the desired state of a medicine. Various meticulous methods for
collection of drugs, their storage and different processes before usage are examples of
bheshaja samskaras for prolonging shelf life of drugs. Evolution of panchavidha
kashya kalpanas and its upkalpanas are outcomes of these efforts. Thus
sthitisthapakatva in aspects of drugs is protecting and preserving the drugs in their
desired state for a longer duration of time.
According to need, various formulations were designed which over the period
of time were tested for their effectiveness and depending on these observations life
span of drugs i.e. period for which it can protect its own gunas were calculated which
was termed as saviryata avadhi of medicine. Word virya represent here the potential
of a drug to give a desired action or karma which is nothing but its guna. This period
up to which a specific medicine can possess its gunas/virya unchanged was termed as
saviryata avadhi of medicines.
Concept of Saviryata avadhi in Contemporary medicine:
Expiry date of medicines is a concept in conventional system of medicine
which comes closer to the concept of sthitisthapakatva as far as drugs are considered.
Here a brief overview of expiry date concept in conventional system of medicine is
done in order to understand its similarity and differences with sthitisthapakatva of
Ayurveda drugs. This also provides a way how Ayurveda should express safety and
efficacy of its medicinal products to foreign countries in this era of globalization.
Definition:
1. Shelf life is the length of time that food, drink, medicine and other perishable
items are given before they are considered unsuitable for sale or consumption.
In some regions, a best before, use by or freshness date is required on
packaged perishable foods.1
2.
The date past which a product, such as food or medicine, must be sold or
removed from availability because it is no longer expected to be fresh or
effective. 2
3. The amount of time that a product can be stored and still is considered safe
and effective for use.3

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4. A food industry term, which, in health care, refers to the length of time that a
blood product, therapeutic or other product may be stored under appropriate
conditions before it must be discarded by law. 4
5. The date appearing on a pharmaceutical product and established by the
manufacturer, beyond which the manufacturer will not guarantee the potency,
purity, uniformity or bioavailability of the product.5
Factors Influencing Expiry Date
Shelf life is influenced by several factors, important ones are;
1. Exposure to light and heat,
2. Transmission of gases (including humidity),
3. Mechanical stress,
4. Contamination by things such as micro-organisms.
Product quality is often mathematically modelled around a parameter
(concentration of a chemical compound, a microbiological index, or moisture
content). These chemical compounds are active principles to which action of drug is
attributed. 6
Safety & Efficacy Issues pertaining to Expiry Date:
The expiration date of pharmaceuticals specifies the date up to which the
manufacturer guarantees the full potency and safety of a drug. Most medications
continue to be effective and safe for a time after the expiration date. A rare exception
is a case of renal tubular acidosis purportedly caused by expired tetracycline. A study
conducted by the U.S. Food and Drug Administration covered over 100 drugs,
prescription and over-the counter. The study showed that about 90% of them were
safe and effective as long as 15 years past their expiration dates. Joel Davis, a former
FDA expiration-date compliance chief, said that with a handful of exceptions -
notably nitro-glycerine, insulin and some liquid antibiotics - most expired drugs are
probably effective.7
Shelf life is not significantly studied during drug development, and drug
manufacturers have economic and liability incentives to specify shorter shelf lives so
that consumers are encouraged to discard and repurchase products. One major
exception is the Shelf Life Extension Program (SLEP) of the U.S. Department of
Defence (DoD), which commissioned a major study of drug efficacy from the FDA
starting in the mid-1980s. One criticism is that the U.S. Food and Drug
Administration (FDA) refused to issue guidelines based on SLEP research for normal

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marketing of pharmaceuticals even though the FDA performed the study. The SLEP
and FDA signed a memorandum that scientific data could not be shared with the
public, public health departments, other government agencies, and drug
manufacturers. The SLEP discovered that drugs such as ciprofloxacin remained
effective nine years after their shelf life, and, as a cost-saving measure, the US
military routinely uses a wide range of SLEP tested products past their official shelf
life if drugs have been stored properly. 8
Hazards of Expired Medicines:
The first concern related to expired drugs is whether they are potentially
harmful if consumed. Reassuringly, there is no published data to suggest harms from
use of drug formulations after their expiry data. The example of degraded tetracycline
causing kidney damage in cases dating back to the 1960′s is drilled into every
pharmacist’s brain. Reassuringly, this occurred with a version of the drug that is no
longer available. While recognizing that case reports are an inaccurate and imprecise
way of identifying harms, the lack of documented harms suggests that degradation of
9
useful chemicals into toxic compounds is rare, if it occurs at all.
Financial Issues & Recycling of expired medicines:
It is unlikely that unused medicines would be entirely eliminated in any
system, and the data indicate that approximately one-quarter of returned medicines are
in a condition potentially suitable for re-use with almost two-fifths of these being
essential medicines as defined by WHO. This concurs with data from a similar study
performed in France. It is possible that returned medicines may not have been stored
in accordance with the manufacturer’s instructions and while the likelihood of this
leading to a significant change to the medicine is slim, it cannot be ignored. However,
with current stability testing guidance and by utilizing modern packaging techniques,
including tamper evident seals and ‘smart’ labels that react to temperature and
humidity, it would be possible to identify inappropriately stored medicines.10
Unused medicines are returned in substantial quantities and have considerable
financial value, with many in a condition suitable for re-use. Many scholars consider
it appropriate to reopen the debate on the potential for re-using these medicines in
developing countries where medicines are not widely available and also within the
UK.
The majority of returned medications contained greater than 75% of the
original amount issued. Identification of therapeutic groups having higher rates of

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returns due to medication changes or surplus to requirements may suggest areas to


target to reduce medication waste.11In USA a scheme exists under which medicines
which have passed expiry date are exported to developing countries. 12 UK charity has
been re-using patients’ unused medicines for humanitarian aid for a number of years.
13

Alternate Medicine & Expiry Dates


Inspections, Compliance, Enforcement, and Criminal Investigations document
of Food and Drug Administration authority of USA specifically exempts homeopathic
drug products from expiration dating requirements. 14
As far as expiration dates of Ayurveda drugs is considered medicines are of two main
categories
1. Herbal
2. Herbo-mineral
Ayurveda sticks to pancha mahabhuta siddhanta for explaining efficacy
period of drugs. Potency of drug is termed as virya of aushadhi and its capacity to
perform desired action is called as saviryata avadhi. Sharangadhara Samhita has
explained saviryata avadhi of various formulations which are as follows.
Generally herbal formulations lose their potency in one year from their date of
preparation, churnas (powders) after two months, gutika (tablets) and lehyas
(confections) after one year, ghrita and tailas (medicated ghee and oils) lose their
potency after 16 months .
In general medicines which are laghupaka lose potency in one year whereas
dhatu kalpas (herbo-mineral preparations) and asava arishtas (self fermented liquids)
preserve their potency with advent of time. 15
Discussion
One important difference is evident in the concepts as Ayurveda gives
importance to type of formulation to decide the saviryata avadhi and consider
chemical composition of drug as a secondary parameter. In modern medicine
chemical composition of a drug is given more importance and different expiry dates
are decided for different drugs depending on their chemical stability.
Approach of Ayurveda towards saviryata has been already discussed in
previous chapter which is on the basis of panchabhautika predominance which up to a
major extent depend on the physical form of a drug. Thus all churnas will have near
what similar physical form and hence are termed as having similar saviryata avadhi.

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It will be wrong thing to say that Ayurveda has not given any importance to chemical
composition of a drug because quotation indicating that asava arishta, metallic
preparations are more stable and can preserve their gunas for a longer duration is
clear-cut observation based on their chemical stability.
Vice versa in case of modern medicine when chemical composition of a drug
is given more importance it will be a incorrect statement to say that it does not
consider type of formulation in deciding expiry dates of medicines. All the aqueous
preparations such as ear drops, eye drops and antibiotic syrups are having lesser
stability when compared to different formulations such as table, injections etc of the
same drugs.
Basis of this difference is the drugs used in modern medicine are pure
chemical compounds of one type which has a well defined structural composition, on
basis of which its stability can be predicted. In case of Ayurveda drugs, they are a
mixture of many chemical components which interact with each other and also with
environment so it is not possible to decide its stability on the basis of its one
constituent. Selecting active principle of a drug for deciding stability of a medicine
can be an alternate approach which has certain limitations which are explained
bellow.
From the point of Ayurveda selecting a Selective Reactive Moiety as drug and
measuring its actual presence in preparation will not serve the purpose of Ayurveda.
Active principles may play major role in total action of drug but cannot be solely
responsible for it. Ayurveda believes in principle of ‘Treat man whole and take the
drug as whole’ so it is not a specific active principle but the whole drug is responsible
for its action and it cannot be attributed to its fraction. Information on isolated
constituents should not be applied directly to the whole herb and studies on in vitro
forms should not be confused with oral administration. The gold standard for proof of
efficacy for a medication is the controlled double-blind trial, which can offer proof of
activity and effectiveness.15 Applying the same rule to expiration period, changes in
whole drug are to be studied and parameters can be discovered for the same. After a
large number of studies are conducted in this regard different standards can be derived
based on it.
Possible parameters for assessment:
According to Ayurveda every drug is panchabhautika in nature. Various
samskaras which are mentioned in Ayurveda Bhaishajya Kalpana have their role in

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extension of shelf life. Stability of drug depends on panchabhautika composition of it.


Prithvi and jala mahabhuta are responsible for maintaining it in yatha sthiti. Increase
in agni and vayu mahabhuta composition of dravya enhances speed of degeneration
of drug by augmenting processes of digestion and decomposition. This has been
quoted by Charaka as

--- 0 5+ $ + ) 2% )2 = $ 9 || . .
Y .^ ^

Thus applying this logic to above explained kalpanas and their mahabhuta
predominance churna has maximum surface area and prepared from grinding
procedures which increase vayu mahabhuta composition in it and lead to easy
decomposing and early expiry. Churnas are having ruksha guna in them and can
easily absorb moisture which is a measure factor in reducing its stability.
Gutika made up of same churna has different mahabhuta predominance i.e.
increase in murtata of dravya which indicates prithvi mahabhuta predominance in it.
Reduced surface area and increased vicinity between particles reduces chances of
moisture and external contamination.
Oil preparations are termed as murchita snehas which mean fats are broken
partially and drugs which are processed with fats acquire inter molecular spaces
between fat molecules and may form loose bonds with them enhancing their stability.
These preparations are nearly free from water content and fats themselves act as
preservation media which further increase its stability.
Thus stability of Ayurveda drugs depends on pancha mahabhuta
predominance in which agni & vayu are responsible for its early expiration whereas
prithvi and jala mahbhuta delay the expiry.
Unfortunately all available analytical parameters enlisted for Ayurveda
formulations in various manuals such as A.P.I., A.F.I. and others are from the point of
quality control and standardization. Ayurvedic approach towards developing the
parameters based on the panchabhautika assessment are currently not established. In
this scenario approach of Ayurveda scholars should be of two types
1. Using available parameters of quality control for this analysis
2. Designing newer techniques which suit principles of Ayurveda by adopting
advances in instrumentation if possible.
Efforts in both of these directions are done in analytical study contrive of this work.

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References –

1. Downloaded from en.wikipedia.org/wiki/Expiry date last accessed on 03-10-


2012
2. Downloaded from http://www.thefreedictionary.com/expiration+date) last
accessed on 03-10-2012
3. Downloaded from (http://medical-dictionary.thefreedictionary.com/Expiry
date) Jonas: Mosby’s Dictionary of Complementary and Alternative Medicine.
© 2005, Elsevier. last accessed on 03-10-2012
4. McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The
McGraw-Hill Companies, Inc. Downloaded from (http://medical-dictionary.
The free dictionary. com/ Expiry date) last accessed on 03-10-2012
5. Downloaded from apps.who.int/medicinedocs/en/d/Js4882e/12.html. last
accessed on 03-10-2012
6. Azanha, A.B.; Faria (July 2005). "Use of mathematical models for estimating
the shelf-life of cornflakes in flexible packaging". Packaging Technology and
Science 18 (4): 161–222. doi:10.1002/pts.686 (http://dx.doi.org /10.1002%2
Fpts.686
7. Cohen, Laurie P. (2000-03-28). "Many Medicines Prove Potent for Years Past
Their Expiration Dates.". Wall Street Journal 235 (62): pp. A1 (cover
story).Downloaded from en.wikipedia.org/wiki/Expiry_date last accessed on
03-10-2012
8. Downloaded from http://www.usamma.6. army.mil/dod_slep.cfm) last
accessed on 03-10-2012
9. Science-Based Medicine » The drug expiry date: A necessary safety and
measure downloaded from http://www.sciencebasedmedicine.org/index.php/
the-drug-expiry-date last assessed on 03-10-12
10. ICH. ICH Harmonised Tripartate Guideline – Stability testing of new drug
substances and products Q1A(R2): International Conferences on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals
for Human Use, 2003.)

11. Tess H James, et al Analysis of Medications Returned to Community


Pharmacies, The Annals of Pharmacotherapy, The Annals of Pharmacotherapy
downloaded from www.theannals.com last assessed on 03-10-2012

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12. Lerner S. A desperate global scavenger hunt to keep AIDS patients alive. New
York Times 2003, 23 July 2003.
13. Bradshaw P, Jarvis A. Reissuing returned medicines to developing countries.
Pharm J 2004;273:514–5.
14. CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be
Marketed Section 211.137 (Expiration dating) Downloaded from http://
www.fda.gov/ICECI/ Compliance Manuals / Compliance Policy Guide last
assessed on 03-10-2012
15. Modern Phytomedicine Turning medical plants into drugs, Iqbal Ahmad Et al,
WILEY –VCH Verlag GmbH & Co KgaA, Weinheim, Printed in the Federal
Republic of Germany, Chapter 2 Quality Control, Screening, Toxicity, and
Regulation of Herbal Drugs, Page no 50
16. Sharangadhara, Sharangadhara Samhita with Deepika and Gudhartha Deepika
Commentaries, edited by Parashuram Shastry, Chaukhambha Orientalia,
Varanasi, India, Sixth Ed. 2005. Page no 13

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