1. 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
2. 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.
SGAM/RSBK/Dr Joban K Modha
3. “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
4. 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.
SGAM/RSBK/Dr Joban K Modha
5. “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.)
SGAM/RSBK/Dr Joban K Modha
6. 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.
SGAM/RSBK/Dr Joban K Modha
9. 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.
SGAM/RSBK/Dr Joban K Modha
18. 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.
SGAM/RSBK/Dr Joban K Modha
19. QUALITY CONTROL OF BHAMAS
PHYSICAL
PARAMETERS
Varitar
Unnama
Rekhapoornatva
Shlakshnatvam
CHEMICAL
PARAMETERS
Varna
Gatarasatvam
Nishchandratva
Apoonarbhavatva
SGAM/RSBK/Dr Joban K Modha
21. 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
SGAM/RSBK/Dr Joban K Modha
22. Easy tests to check Tamra Bhasma
SGAM/RSBK/Dr Joban K Modha
24. 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.
SGAM/RSBK/Dr Joban K Modha
25. Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1)
[Rule 161 (2)] List of poisonous substances - Ayurvedic
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.
SGAM/RSBK/Dr Joban K Modha
26. Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1)
[Rule 161 (2)] List of poisonous substances - Ayurvedic
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.
SGAM/RSBK/Dr Joban K Modha
27. 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 ?
SGAM/RSBK/Dr Joban K Modha
32. 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
33. DOSAGE FORM SPECIFIC
PRECAUTIONS TO AVOID ADRs
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
34. DOSAGE FORM SPECIFIC
PRECAUTIONS TO AVOID ADRs
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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
35. 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
SGAM/RSBK/Dr Joban K Modha
37. FORMULATION SPECIFIC
PRECAUTIONS TO AVOID ADRs
Tablets-
Yogaraja guggulu-Constipation, Reduced urine
output
Gokshuradi and Punarnavadi- Diuresis,
Sleeplessness
Chitrakadi–Stomatitis
Laghu sootashekhara – Constipation, mouth ulcer
Rasnadi-Constipation
Lashunadi-Constipation, Burning
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
38. 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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
39. FORMULATION SPECIFIC
PRECAUTIONS TO AVOID ADRs
Asava-Arishta
Lodhrasava, Saraswatarishta-DM
Dashamula-Constipation
Sariva,Usheera-Kaphaja disorders
Kharjoora, Shreekhanda-DM
Kutaja- Constipation,Vatic disorders
Kumari no 1-Menorrhagia
Ashoka-Constipation
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
40. 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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
41. 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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
42. DISEASE SPECIFIC PRECAUTIONS TO
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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
43. DISEASE SPECIFIC PRECAUTIONS TO
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
SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
44. 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
SGAM/RSBK/Dr Joban K Modha
45. 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
SGAM/RSBK/Dr Joban K Modha
46. Medicines which contains Hartal
Hartal malham
Rasa Manikya-dose?
Hartal bhasma
Talsindura
SGAM/RSBK/Dr Joban K Modha
47. Medicines which contains lead
Vaatvidhvansan Ras
Tribang Bhasma
Garbhapaal Ras
SGAM/RSBK/Dr Joban K Modha
48. 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.
SGAM/RSBK/Dr Joban K Modha
49. 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.
SGAM/RSBK/Dr Joban K Modha
50. 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
SGAM/RSBK/Dr Joban K Modha
51. 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.
SGAM/RSBK/Dr Joban K Modha
52. 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
SGAM/RSBK/Dr Joban K Modha
53. 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.
SGAM/RSBK/Dr Joban K Modha
54. 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
SGAM/RSBK/Dr Joban K Modha
55. 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.
SGAM/RSBK/Dr Joban K Modha
56. Vatsanabh yoga
Tribhuvan kirti ras
Agnitundi vati
Anand bhairav ras
Krimikuthar ras
Sanjivani vati
Sutshekhar ras
Shwaskuthar ras
Vaatvidhvamsan ras
SGAM/RSBK/Dr Joban K Modha
Agnitundi Vati- also contains Kupilu*
*Break after 15 days/avoid in
children
57. 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
SGAM/RSBK/Dr Joban K Modha
58. Non sulfide form of mercury-
Chandmarutam ras -Ras karpura
SGAM/RSBK/Dr Joban K Modha
59. 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.
SGAM/RSBK/Dr Joban K Modha
61. 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.)
SGAM/RSBK/Dr Joban K Modha
65. 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
SGAM/RSBK/Dr Joban K Modha
66. 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
SGAM/RSBK/Dr Joban K Modha