Introduction : Rasashastra, immortalized in the form of elegant science is now facing the media issues of toxicity. The western concept stands on media publicity with a biased sample based research. Institutional research proves safety and western negative research always proves toxicity of the same medicines. It is not only the anti-Indian Pharma movement for MNC’s to enter but also a prick to our patriotism.
Materials: JAMA article –Aug 27, 2008 and JAMA Dec 15, 2004 and related articles.The JAMA published a decade researched article measuring the prevalence of medicines with detectable toxic metals in the entire sample and stratified by country of manufacture and rasashastra status.
Methods : A critical retrospective review and prospective research solutions.
Impact of JAMA Dec 15,2004 Impact of JAMA Dec 15,2004
1.Chinese Drug Market Jumped 19% in 2007 to US$50 Bln - WiCON Launches China Pharmaceutical Guide 2008 (3rd Edition)
2.The Rs8,000 crore by sales herbal medicine market in India, according to ADMA, received a blow from the 2004 study that triggered banning of Ayurvedic medicines in some countries, including Canada and the UK.
We are still reeling under that damage, we have another We are still reeling under that damage, we have another
JAMA.. JAMA..
NOW What's the Blame about? NOW What's the Blame about?
- Toxicity of Ayurvedic medicines.
- Prevalance of toxic metals in Indian manufactured medicines than US manufacture.
- Prevalance of toxic metals between Rasashastra and non-rasashastra medicines. .
What's the Claim about?
- High estimated daily metal ingestion.
- Detectable toxic metals.
- US manufactured medicines are better than Indian manufacture.
- Rasashastra medicines contained more metals than non-rasashastra medicines .
Study Design for the research done. 5 internet Search engines.Country Of 25 Web sites. manufacture,suppliers,GMP. 673 identified products,XRF for the analysis . 230 selected ayurvedic medicines. The above were the materials for the research carried on to target on Rasaushadies.
The article presented at jignyasa -2008 ,MYSORE
Blames and Claims On Marketed Rasaushadies….!!??
Data analysis was based on. Unit dose weight as recommended ----to calculate the amounts of daily doses.Acceptable Limits from the California Safe Drinking Water & Toxic enforcement Act.
ANSI/NSF gives the international dietary supplementary standard. ANSI 173 states dietary supplements should not contain an undeclared metals thatwould cause intakes greater than
20µg/d of Lead
20µg/d of Mercury
10µg/d of Arsenic
Results of the research carried out in JAMA.
- 193 out of 230 medicines received and analyzed. (37 diff manufacturers)
- Prevalence of metal containing products-20.7%
- 95% of these Products were sold by Websites.
All metal containing products exceeded 1 or more standards for acceptable daily All metal containing products exceeded 1 or more standards for acceptable dailyintake.
Rasashastra contained more metals compared with non-rasashastra medicines.
Obviously!b’coz rasaushadies mean that!
Also the results showed that….
Ayurvedic medicines of US contained
Lead ------less than 25 µg/g
Indian manufactured medicines
Both lead & mercury-------104 µg/g
US manufactured rasashastra medicines did not contain detectable mercury and had
lower lead concentrations than those manufactured in India.
ADMA----likelihood of presence of metal.
AHPA-----less likely to contain metals.
Indian manufactured Rasashastra status medicines would cause greatest Pb & Hg
concentrations often substantially exceeding all standards.
Comments out of research
100/10,000 times more than acceptable limits of metals by Indian manufacturer.
Metals identified in the sample of ayurvedic medicines are likely a result of
PRACTICE OF RASASHASTRA or contamination.
And now a million dollar Question is
Honestly! Today how many Practitioners do practice
only non-rasashastra medicines?
Before that shall we glance the limitations where the fact lies.
Dec 15, 2004- limitations
Statistical data : Statistical data :
Population on Ayurvedic medicines
0.8 billion in India
7, 50,000 in USA.
No of cases of heavy metal toxicity
55 cases in 24 years.
Are these ayurvedic medicines prescribed by a qualified personnel ? - Not
known –
Percentage of medicines actually containing metals and minerals in processed form
Limitations Aug 28,2008 Limitations Aug 28,2008
Potential misclassification of Products Country of manufacture & rasashastra status.
Information provided by website,label,manufacture is contradictory/ambiguous.
Some Products are unobtained.
Magnitude of potential toxicity with acceptable standards.
Specific physical form/chemical species of metals is unknown.
Physico-chemical form of metals in Rasashastra medicines (metals) & their
BIOAVAILABILITY!
They say to their foresight …..
No evidences of bhasmas being claimed as non-toxic.
Rasashastra is not included in the scope of practice being developed by US based
NAMA (National Ayurvedic Medical association)
Why such a blame with a biased objective? Why such a blame with a biased objective?
- Is it a trick to pull the economy?
-To get the gate pass for the MNC’ s to enter India?
-Targeting for the Anti-Indian Pharma movement?
-Trick To Create Anti-Rasashastra Movement.
-Prick to our Patriotism…!
When 65-80% of worlds population uses traditional medicine as their
Primary health care…..
Why ayurvedic medicines are chosen? Why ayurvedic medicines are chosen?
To improve immune functioning.
To improve overall functioning.
To increase the quality of life.
To cope up with side effects from conventional therapies.
Relieve symptoms from their illness.
The TRUST .
Shall we bring these Evidences into your notice Dr.Saper? Shall we bring these Evidences into your notice Dr.Saper?
Effect of Herbo mineral preparation in 40 cases of HIV
Case study was conducted by Prof: Alka Deshapande of J J Hospital Mumbai.
Clinical study: All 40 patients were given a herbomineral preparation containing
508mg of heavy metal residence for 180 days. The patients were followed for
another 60 days for late toxicity.
Report: CD4 count went up initially and later got stabilized. No symptoms of
toxicity observed. There is negligible increase in biochemical parameters which
are clinically insignificant.
And more evidences… And more evidences…
Acute toxicity of makardwaja was carried out on experimental animals by Dr.Dubey
et.al at centre for advanced research in Indian System of Medicine SASTRA Tanjavur.
Experimental study: Acute and chronic toxicity study was conducted on albino rats,
and dose of makardwaja was 50 mg/kg daily.
head2right
Report: no lethality was found at highest dose of 300mg/kg daily .
Chronic toxicity study: this was carried out on rats with average weight of 1.86 kg up
to 3 months.dose was 50 mg/kg daily
Report: No adverse effect on haemopoietic, gastro intestinal, hepatic
and kidney function test were noted.
So they the westerners call it a MYTH!
But we do call it
A Mystery……!!!!
Ways to get against such blames
Patients: Get the treatment from the experts,communicate with the physician.
Prescribers: Written Prescriptions by the practitioners,Probe for the use of such safe
drugs,Be aware of the centere which can provide reliable information.,Report all adverse
events suspected to be have been caused by Rasaushadies (Herbo-mineral drugs).
Industry: Package inserts and labels,avoid misleading claims.
Drug regulation :Vigilance,Networking with prescribers and patients.
Academic Institutes : Design Studies to collect information,Publish,Empower
Patients,Physicians.
Under CCRAS
443634 registered practitioners.
13887 government dispensaries.
2394 hospitals with 42087 beds.
225 colleges conducting degree course.
61 post graduate centres.
7786 manufacturing units.
39 research institutes functioning.
Then all these should commit to counter-answer such issues. Then all these should commit to counter-answer such issues.
What we need?
Research on Case by Case basis.
Record keeping and documentation.
Extensive larger Clinical trials.
Stimulate the basic research.
Pharmacovigilance
An ayurvedic pharmacology strongly says a Potent poison becomes the best drug on
proper administration.On the contrary,even the best drug becomes a potent poison if used
incorrectly.------- Charakaacharya.
Facts to prove the time tested
Population out bursting ! India wouldn’t have this issue if heavy metal toxicity
prevailed since ages.
Analysis of metallic medicine in terms of modern pharmacology.
Complexity of metallic medicines& Chelating agents.
Concept of Polymorphism and other allied sciences support.
Compounds with in built antidotes and rational drug designing.
ADMA says
“ Quality standards, clearly laid down by the government's department of Ayurveda,
yoga and naturopathy, unani, siddha and homoeopathy (AYUSH), are there for
"everyone to follow” "everyone to follow”
On the other hand
"There are no limits for domestically consumed medicines, or Rasa Shastra medicines,'
said Saper said Saper said Saper said Saper, who recommends strictly enforced, government-mandated daily dose
limits for toxic metals in all dietary supplements.
Can just the presence of heavy metals mean that it can
create toxicity?
If the answer is NO!!! We need to counter-answer such MEDIA If the answer is NO!!! We need to counter-answer such MEDIA
ISSUES…….. ISSUES……..
Then Get ready for the BATTLE!!!!..... Then Get ready for the BATTLE!!!!.....
To conclude……
Today only a handful of practitioners follow the practice of preparing medicines
for their patients. Production and sale of dugs has become formalized into a thriving
industry. This commercialization has brought with it many challenges about safe use
of Rasaushadies. The samples taken in the western research were only from selected
companies which strictly might not have followed the classical methods. After varied
forms of Samskaras the pharmaceutically prepared drug combination are surely
different from the elemental forms. But even the most modern equipments are not able
to signify this difference .If pharmacies followed the manufacturing procedures
stringently and are able to give the scientific validations we wouldn’t have faced the
repeated JAMA articles. Both the Govt.of India and Indian systems of medicine
fraternity don’t have any standard pioneer laboratory research centers. Even the
frontier institutions are not making an attempt of counter-answering such media
publications. Thus we should move forward to embrace Pharmacovigilance,
governance and answer them.
