how to avoid ADR of Ayurved medicines

Dr Joban Modha
MD PhD fellow (IOD, Fl. USA)
Dept. of R.S.B.K. S.G.A.M.
Gujarat Ayurved University
Jamnagar
Email: jkmodha@gmail.com
SGAM/RSBK/Dr Joban K Modha

Why this workshop ?
 To minimize ADRs
 To minimize prescription errors
 To avoid dispensing errors
 To create awareness about ADRs
 A contraindication is a specific situation in
which a drug, procedure, or surgery should
not be used because it may be harmful to the
person.

 “Even a strong poison can become an excellent
medicine if administered properly. On the other
hand even the most useful drug can act like a poison
if handled carelessly“ – Charak Samhita
POISON
MEDICINE

Dispensing Errors: The Numbers
 98.3% accuracy in dispensing medications
 Therefore, 1.7% inaccuracy rate
 Over 3 billion medications dispensed per year
 4 errors per day per 250 prescriptions filled
 Over 51 million dispensing errors per year
Flynn E, et al. J Am Pharm Assoc. 2003;43:191–200.

“Ghee or milk consumed when the
digestive fire and metabolism is on a
low ebb works like poison”
(Viṣopamam)
( Astanga Hridayam; Shastri H, editor. Varanasi: Chaukhambha
Samskrit Sansthan; 2011. p. 561.)

HEAVY METAL TOXICITY CONCERNS
 The use of metallic preparations as single drugs
or as ingredients in many Ayurvedic medicines
has evoked concern and debate in the scientific
and public forums in the recent times.
 Some studies has warned that users of Ayurvedic
medicines may be at risk for heavy metal toxicity
and suggested that testing of Ayurvedic
medicines for toxic heavy metals should be
mandatory.

JAMA CONTROVERSY

HEAVY METALS
 A heavy metal is one with a specific gravity of 5gm
cm-3 or more.
 They are stable elements and cannot be
metabolized by the body.
 Some heavy metals such as zinc, copper,
cobalt, chromium, iron and manganese are
required by body in small measures.
 These same elements can be toxic in larger
quantities.
 Heavy metals may enter the body in food, water, air,
or by absorption through skin.

UNESCO

UNESCO/BBC

The king of poison
The poison of kings

AyurVaidya’s take:
 The heavy or toxic metals in elemental form are toxic but
those in compound form i.e. Bhasma are safe for
humans.
 Bhasma are made from various metals, metal mixtures
and alloys.
 The way they are prepared, evaluated and therapeutically
used leaves no doubt about their safety to the humans.

QUALITY CONTROL OF BHAMAS
 PHYSICAL
PARAMETERS
Varitar
Unnama
Rekhapoornatva
Shlakshnatvam
 CHEMICAL
PARAMETERS
Varna
Gatarasatvam
Nishchandratva
Apoonarbhavatva

CURD TEST FOR TAMRABHASMA
Most of the copper bhasma and other minerals having
copper bhasma are in the form of CuO and CuS in final
product.
It is a test to check free copper metal, because when free
copper reacts with lactic acid (one of the component of curd)
copper salts are formed which gives blue colour and it is
toxic in nature and produces nausea, vomiting because of
free copper ions…
6/10 market
samples of
Tamra Bhasma
could not clear
the test

Easy tests to check Tamra Bhasma

Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1)
[Rule 161 (2)] List of poisonous substances - Ayurvedic
Medicine
I Drugs of vegetable origin
 Ahipena: Papaver somniferum Linn.
 Arka: Calotropis gigantea (linn.)R. Br. ex. Ait.
 Bhallataka: Semecarpus anacardium Linn. F.
 Bhanga: Cannabis sativa Linn.
 Danti: Baliospermum montanum Mull. Arg.
 Dhattura: Datura metal Linn..
 Gunja: Abrus precatorium Linn.

Medicine
I Drugs of vegetable origin
 Jaipala (Jayapala): Croton tiglium Linn.
 Karaveera: Rerium indicum Mill.
 Langali: Gloriosa superba Linn.
 Parasika Yavani: Hyoscyamus inibar Linn.
 Snuhi: Euphorbia neriifolia Linn.
 Vatsanabha: Acontium chasmanthum Stapfex
Holm.
 Vishamushti: Strychnox nuxvomica Linn.
 Shringivisha: Acontium chasmanthum Stapfex
Holm.

Medicine
II Drugs of Animal Origin.
Sarpa Visha Snake poison.
III Drugs of Mineral Origin
Gauripashana: Arsenic.
Hartala: Arseno sulphide.
Manahashila: Arseno sulphide.
Parada: Mercury.
Rasa Karpura: Hydrargyri subchloridum.
Tuttha: Copper sulphate.
Hingula: Cinnabar.
Sindura: Red oxide of lead.
Girisindura: Red oxide of mercury.

IF NOT –WHY?/IF YES-HOW?
 Is It Applicable Universally ?
 Are We Aware of Original References ?
 Do We Know The Ingredients And Their
Hypersensivity ?
 Do We Are Confident Regarding Ayurvedic
Prescriptions?
DO OUR MEDICINES HAVE
CONTRA INDICATOINS ?

PRECAUTIONS TO AVOID ADRs
Dosage form specific
Formulation specific
Disease specific
Dose specific
Doshic affinity
Manufacturing method
Anupana- Sahapana-Bala-Desha-
Kala-Agni-Prakriti- Satwa-Satmya etc.
Ref: Dr MS Krishnamurthy www.ayurblog.comSGAM/RSBK/Dr Joban K Modha

DOSAGE FORM SPECIFIC
Fresh Drug – Acute conditions (Psychological Setup),
Children, Susceptible individuals (Garlic, Onion,
Ajawain, Colour specific, Cow’s urine etc)
Decoction – Children, women, poor mental ability,
Minor sufferings, Non accustomed, Religious
Tablets-Younger age group (size of tablet), Higher
society, Extra awareness, Vomiting, Tastelessness,
Constipation, Indigestion etc
Powders-Younger age group, women, Nausea, Mental
disliking
Syrup-DM, Disliking towards Preservatives and
colouring agents, Consistency specific
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com

DOSAGE FORM SPECIFIC
Asava-Arishta-Religious, Women, Nausea/
Susceptible, Paittic individuals, DM
Avleha-DM, Gurutva, Indigestion
Ghee and Oil- Gurutva, Indigestion and
Nausea, Liver disorders, Renal insufficiency
Rasoushadhis-Renal-Cardiac-Hepatic-
Neurological-Pancreatic disorders

Most popular Rasaushadhi in our practices
 Aarogyavardhini Rasa
 Bruhad or Laghu
Suvarna Vasant Malini
Rasa
 Chandamarutham Ras
 Chandraprabha Vati
 Garbhpal Ras
 Laxmivilas Rasa
 Mahayograj Guggulu
 Makardhwaja Rasa etc.
 Panchamrita Parpati
 Simhanada Guggulu
 Swasakuthar Rasa
 Tamra Bhasma
 Tribhuvan Kirti Rasa
 Trivanga Bhasma
 Vaat Vidhvamsana Rasa
 Yogaraja Guggulu
http://apps.who.int/medicinedocs/pdf/whozip23e/whozip23e.pdf

FORMULATION SPECIFIC
Choorna-
Sitopaladi, Talisadi-DM
Avipattikara- Diarrhoea, DM
Pushyanuga-Constipation
Hingwashtaka-Leucorrhoea, Bleeding disorders,
BPH, Constipation
Shivakshara –Urinary incontinency, BPH
Shatavari-Sore throat, Kaphaja Roga
Haritaki- Garbhini

Tablets-
Yogaraja guggulu-Constipation, Reduced urine
output
Gokshuradi and Punarnavadi- Diuresis,
Sleeplessness
Chitrakadi–Stomatitis
Laghu sootashekhara – Constipation, mouth ulcer
Rasnadi-Constipation
Lashunadi-Constipation, Burning

FORMULATION SPECIFIC PRECAUTIONS TO
AVOID ADRs
Leha-
Shatavari-Sore throat, Cold, Cough, Asthama,
Indigestion
Chyavana prasha,Dashamula hareetaki-
Mandagni, Constipation, Burning of the body, Non
specific headache
Pancha jeeraka guda-Excess appetite
AmritBhallatak Rasayan: Paittik disorders, blood
disorders
Trivrit lehya-Ulceration
Haridrakhanda rasayana-Dry skin, Vaatik P/P/V

Asava-Arishta
Lodhrasava, Saraswatarishta-DM
Dashamula-Constipation
Sariva,Usheera-Kaphaja disorders
Kharjoora, Shreekhanda-DM
Kutaja- Constipation,Vatic disorders
Kumari no 1-Menorrhagia
Ashoka-Constipation

FORMULATION SPECIFIC PRECAUTIONS
TO AVOID ADRs
Ghrita and Taila-
Kalyanaka- Menorrhagia
Shatavari, Falaghrita- Cold, Sore throat
Pinda taila- Internal administration
Most Taila/Ghrita-Rhumatoid arthritis
Maharaja prasarini-Burning chest

Hepatic/ Biliary Disorders-Haratala, Manashila,
Vatsanabha, Naga, Vanga, Dhattura, Hingula
Anaemia- Constipatives, Hingula, Vatsanabha,
Gandhaka, Navasagara
Fever-Gastric irritants, Khadira-Ashoka-Lodhra-
Arjuna-Bilva-Shilajatu
Mouth ulcers-Haratala, Manashila, Dhattura,
Hingula, Dashamula katutraya, Kanakasava, TBKR, A
Bhairava
Back ache-Sangrahi..
DISEASE SPECIFIC PRECAUTIONS TO
AVOID ADRs

AVOID ADRs
Male Sterility-Vatsanabha, Jayapala, Navasagara, Kshara,
Lavana
Head ache-Constipation, Dysuria, Irritant drugs
Peripheral neuritis-Hingula, Manashila, Vanga
Scanty menstruation-Chandrakala rasa, Bolabaddha rasa,
Ashokarishta(mere)
Menorrhagia-Formulations containing Manashila, Haratala,
Jayapala, Hingu, Kumari, Shanapushpi

AVOID ADRs
Eye disorders-Manashila, Naga, Vanga, Bhallataka
Ear disorders-Unless specified oils(mridupaka),Acidic
substances
Tonsilitis-Shatavari yoga, Coolants to scalp, Ghrita
preparations
Cold, Cough, Asthama-milk products, Shatavari, Coolants,
medicated Ghee –if not specified
Cardiac diseases-Hingula, Vatsanabha, Jayapala, Dhattura
Urinary calculi-Hingula, Tamra bhasma, Vanga, Naga,
Dhattura
 PCOD-Careful usage of irritants
 Lactation-Anti diabetic, Sthoulyahara medicaments
 Gynaeco-mastia- Galactogogues like Shatavari

BE CAUTIOUS while
penning
Yastimadhu, Kantakari
Sarpagandha,Vidanga, Soma, Kutaja, Vacha, Parsik
Yavani*
Bilva, Dhattura, Vacha, Bakuchi, Bhallataka
Trivrit, Danti, Sonamukhi, Katukarohini
Vatsanabha, Vishatinduka
Naga, Vanga, Tamra, Parada, Hingula, Haratala, Manashila
Un known/Less known
 *banned or restricted in US/UK/EU

Medicines which contains Manahshila
 Shvaskuthar Ras (for asthma with cough and in
remittent fever with cerebral complications).
 Smriti Sagar Rasa (for psychotherapy).
 Unmada Gajakesari Rasa (psychological
disorders).
 Externally, the paste of Mansil is applied on diseases
of skin. e.g. hair removing creams or Switra related
medicines. Test dose should be applied first.
 Shilasinduraa

Medicines which contains Hartal
 Hartal malham
 Rasa Manikya-dose?
 Hartal bhasma
 Talsindura

Medicines which contains lead
 Vaatvidhvansan Ras
 Tribang Bhasma
 Garbhapaal Ras

Medicines which contains Bhallataka
 Bhallataka Rasayana:
 Amrita Bhallataka Ghrita:
 Sanjivani Vati:
 allergic reactions like rash, itching and swelling
 the antidotes: externally -coconut oil, rala ointment,
ghee, coriander leaves pulp or butter mixed with
Musta (Cyperus rotundus)
 A cream of Shatadhauta can be administered.

Medicines which contains Gunja
 Neelibhrungadi tailam
 Sarivadi Vati
 If not purified properly or if used in excess dosage than
prescribed, it can cause severe vomiting and diarrhea.
 Unpurified seed powder used over wounds or direct
contact with blood can also produce toxic effects.
 Roots – if used in excess dose can cause vomiting
It is best to avoid Gunja or medicines containing it during
pregnancy, lactation and in children below 5 years of age.
 Antidote: There is no specific antidote for abrin
poisoning, and treatment is mainly supportive with
intravenous fluids and correction of electrolyte
abnormalities.

Medicines which contains Ativisha:
 Kutaj Ghan Vati
 Chandraprabha Vati
 Khadiradi Gutika
 Rasnairandadi kashayam
 Bal chaturbhadra Churna
 Yogaraja guggul
 May produce allergic reactions like skin rash,
burning, itching and swelling
 Overdose

Side effects of Guggulu preparations:
 It should be used under observation in people who
are suffering from hypertension or any serious illness
of chronic origin, in pregnancy and during active
severe bleeding.
 It is not a single handed remedy in the mentioned
disorders and shall need the support of co-
prescriptions in the form of disease modifying
formulations.

Are not alternative for
other Guggulu preparations
 Sinhnaad Guggulu contains Eranda Taila so the most
common side effect occurs due to the purgative action of
Simhanada Guggulu. Some people may experience loose
stools. In high dosage, it can also cause diarrhea. Rarely,
people have reported restlessness after taking it, which
generally occurs with its high dosage
 Yogaraja Guggulu contains Ativish, Hingu and Vacha..
So uses with caution in Ushna Kaal, Prakriti. It may lead
to some rare side effects in some sensitive people.
 Acidity
 Heartburn
 Burning sensation in abdomen

Medohar Guggulu is POSSIBLY SAFE and WELL
TOLERATED with dosage less than 2 grams per day. But it
contains Vidanga and other Ushnavirya Dravyas so heavy
dosage may cause following side effects.
 Heartburn
 Dull headache (commonly associated with acidity and
occurs in people with history of acidity, gastritis or ulcer)
 Increase in appetite (it may not its side effects, as people
feel it initially and after a few days it reduces itself)
 Loss of appetite (it occurs in people with chronic gastritis
or digestive troubles)
 Medohar Guggul in pregnancy and lactation it is
contraindicated as it has warm property, which means it
produces heat in the body.

 Sushruta has explained Torticollis (neck stiffness) and
yellowish discoloration of eyes, stools and urine as the
toxic effect of Vatshanabhi.
 The text book Rasaratna Samucchaya explains 8 stages of
toxic effects of Vatsanabha. These stages refers to
spreading of poison in different parts of the body. These
stages are also dependent on level of toxicity and dosage
of Vatsanabha.
 1st stage – Twak Vikara – skin rashes,
 2nd stage – Vepathu – tremors
 3rd stage – Daha – burning sensation all over the body.
 4th stage – Vikrata – deformity
 5th stage – phenodgati – frothing
 6th stage – skandha bhanga – drooping and wasting of
shoulders.
 7th stage – Jadyata – wasting and comatose of whole body.
 8th stage – Marana – death.
Evil effects of Vatsanabha

Antidotes for Vatsanabha poisoning:
 The treatment for Vatsanabha is possible upto 5th stage
only. – (Rasaratna Samucchaya)
During Aconitum ferox toxicity due to over-dosage or
usage without purification procedure, then ghee along
with Tankana bhasma is given.
Combination of Honey, ghee and bark of Arjuna
(Terminalia arjuna) is also used as antidote.
 Whenever Vatsanabha is used in any formulation,
Tankana Bhasma (Borax calx) is always used in equal
quantity. If used so, it will nullify all the toxic effects of
Vatsanabha and hence there will not be any toxic effects.
Example: Tribhuvana Kirti Ras – a potent Ayurvedic
medicine used in fever, has both Vatsnabha and Tankana.

Vatsanabh yoga
 Tribhuvan kirti ras
 Agnitundi vati
 Anand bhairav ras
 Krimikuthar ras
 Sanjivani vati
 Sutshekhar ras
 Shwaskuthar ras
 Vaatvidhvamsan ras
Agnitundi Vati- also contains Kupilu*
*Break after 15 days/avoid in
children

Ras atisevan/ Kshar atisevan
 Single Prescription shouldn’t contain similar drug in
more than 2 compounds…
 E.g. “Ras”…Guduchi
 Medicines containing kshar for oligospermia
 Tikta ati ras sevan:
 Neem
 Guduchi
 Vasa
Lavana ras pradhan aushadh atisevan

Non sulfide form of mercury-
Chandmarutam ras -Ras karpura

SARPAGANDHA
 Sarpagandha side effects –
 It is contra indicated in – Bronchial asthma, Duodenal
ulcer, Hyperacidity, Renal disorders.
 Because it stimualtes uterus, this herb should not be used
during pregnancy.
 It is not suitable to be used in cases of
depression.
 It is not ideal to use this in children and after delivery.
 It is not ideal to take this medicine along with Digoxin,
Levodopa.
Special care is needed when it is administered along with
other medicines for high BP. The combined effect may
lower the BP to a great extent.
 Its sleep enhancing effect may further increase if taken by
an alcoholic.

Religious Sentiments

Poisons, which remain in the body for
a long period of time and cause
intractable diseases, are known
as Garaviṣa.
(Shastri H, editor. Varanasi: Chaukhambha Samskrit
Sansthan; 2011. Astanga Hridayam; p. 902.)

Dispensing Errors in the Work
Area
• Labels on bins and shelves
 Separate by route of administration
(external/internal/injectable, etc.)
• Use auxiliary labels for externals
– Amoxicillin oral suspension for ear infection thought by
parents to be drops administered in child’s ear
• Review published safety alerts for look-alike/
sound-alike drugs and frequent dispensing errors

Last sip….
A look into original classical references
Knowledge of recipe and related ingredients
Thinking before acting
A thorough re-view/case study
Faith and confidence
Acceptance of truth
Self limitation and limitation of science

THANK YOU

how to avoid ADR of Ayurved medicines

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