Need For Ayurvedam Research

Author’s view expressed, and absolutely there is a need for Research in Ayurvedam at global level.
A mile-stone for developing alternative remedies where Allopathy is helpless and developing a new molecule in modern pharmacotherapy is laborious time, consuming process and costly affairs.

For example in Indian Ayurvedic pharmaceuticals companies have business worth rupees hundreds of crores, because patients accept them and on decades of their use nothing untoward is reported except on rarest occasions which is quite common with allopathic drugs.
Let us not bother about a sick man that why should a person die of a snake bite? By the time we administer the so called antivenin is too late, and too costly. And if the toxin is fixed to tissues our antivenom will not work. But, in Ayurvedam says there are remedies, but it’s very unfortunate that there is no research till now

When we look at some countries they are exporting medicinal plants worth Rs.20, 000 crores and more annually. Their herbal anti-malarial are saving lives in multidrug resistant malaria and we have not yet forgotten Korean gin seng, so potential is there for research.
I want to make it crystal clear that we are not debating which system of medicines is superior. Pharma Labs wants remedies which influence human thinking that nature not only produces diseases it has given medicines too alleviate human suffering to achieve it. One has to do result oriented research that Pharma companies has to identify in the right direction.

I can advice that which fields requires more attention on research, and there are as follows:

Diet and disease whether diet and Rheumatic problems are related
Developing new Anti Malarial and Anti filarial drugs.
Developing remedies for skin diseases like Vitiligo, Psoriasis and Cosmetic Dis-orders.
Non-Surgical cure for Cataracts.
Cure for Paralysis and Epilepsy.
Diseases of liver like Hepatitis A,B,C etc.,
Psychiatry
Obesity
AIDS
Is painless human delivery possible by Non-invasive Ayurvedic remedies?
Diseases of kidney like kidney stones, acute, chronic kidney failure.
The most serious problem I came across is, correct identification of medicinal herbs, and from where we can obtain them?
Establishing a good library with ancient ayurvedic texts in which thousands of remedies are already described. Only we have to find out how far they are effective under field conditions of course giving reference to production and marketing. Profitability in relation to investment in other words whether the project is viable or not?
The Pharma Labs should start a publishing writing essay which produces new enthusiasm to the general public also and research objectives Labs should be the talk of the town and everywhere in the world. This is possible only by developing new drugs by research.
With firm determination we have already wiped out small pox and to some extent polio and we have now vaccines for many others, this is achieved only by doing research.
Let us not bother right now about Cancer Cure, Diabetes Cure and in born errors of metabolism as this is already under the care of senior people.
Our forthcoming research should be 100% to development of drugs which are effective, simple and affordable. Unless one stick to this job with full commitment nothing will be achieved and the project requires work and should be carried on quality

It is estimated, though not accurately, but there are 220 ayurvedic medical colleges in India. Their contribution in research is less due to lack of support.

It’s time for research, for example:

For Painless delivery we have to take North side root of a sugarcane plant and roll over it with pure silk thread, equal to patient height. If a woman is in the 2nd stage of normal labour then tie over the “Thread” to her mid-abdomen, for painless delivery. Ayurvedic Books says that there will be a painless delivery.
Take full of Putranjeeva Plant seeds, available in Arunachal Pradesh, make its watery juice and administer orally to snake bitten person. Ayurvedic books say he will be saved. And also if you administer Pachhi Pasupu.
Give 30 ml watery juice of entire plant of Adavi Jilakara, a Rabies patient survives.
Give a drop of early morning (before sun rise) “Julledu Paalu” with honey to a malaria patient he will be cured.

Did anyone really tried to do research on this simple remedies. If not in humans at least on animals? Countless remedies are available in Ayurvedic literature. Only need is research.

LAW RELATING TO RESEARCH:

LAW RELATING
TO RESEARCH
IN
AYURVEDAMU
AND OR PHAN DRUGS ACT
OF U.S.A
ALSO FOLLOWED IN INDIA
DRUGS AND COSMETICS ACT – 1940

Subrmle’c’ of chapter IV – A

A. 33 –EEC -Restrictions do not apply to vidyas and Hakeem’s, for treating their own patient, manufacture of small quantities for examination, test; or analysis.

B. UNDER PARA 7.5 OF CENTRAL FDRUGS STANDARDS CONTROL ORGANIZATION (CDS CO) UNDER DRUGS CONTROLLER GENERAL OF INDIA “For the herbal remedies and medicinal plants that one to be chemically evaluated for use in allopathic system, which may later be used in allopathic hospitals, the procedures laid down by the office of the DCG(I) for allopathic drugs has to be followed this does not pertain to guidelines issued for chemical evaluation of Ayurveda, siddha; or unani drugs by experts in those systems of Medicine which may be used later in those hospitals and clinics.

However when clinical trials if Herbal drugs used in Indian system of medicine and Homeopathy one to be under taken in allopathic Hospitals, Association of Physicians from the concerned system as co-investigators/collaborators/members of expert group is desirable for designing and evaluating the study.

7.5.1 CATEGORIES OF HERBAL PRODUCTS

The Herbal products can belong to any of the following three categories

A lot in Known from ancient Ayurvedic literature and in use from long time, that particular drug or herbal, plant etc.
Anything newly discovered not existing in Ancient books should be treated as “NEW CHEMICAL ENTITY” (NCE).
A plant or compound never used clinically above 02 and this categories require all the regulations as governing new Allopathic drugs, that is all phases of so called clinical trials.

7.5.2 It is Important that plants and herbal remedies currently in use or mentioned in literature of recognized traditional system of medicine is prepared strictly in the same way as described in the literature while incorporating “GOOD MANUFACTURING PRACTICES” =GMP NORMS FOR STANDARDIZATION.

It may not be necessary to undertake phase I studies.
Neither any toxicity studies are needed for phase II trials unless there are reports suggesting toxicity or when the

Herbal preparation is to be used for more than three months.
It chemical trials are made with already known drug by Allopath an expert in Indian systems of medicine must be an associate investigator.

The basic question is can we avoid Allopathic rules of clinical trials for our proposed Ayurvedic research as none of us have cash resources. Under these circumstances what existing rules can help us is discussed as under.

AN INSIGHT IN TO REGULATIONS GOVERNING
“ORPHAN DISEASES AND DRUGS”
From “Research Journal OF PHARMA CEUTICAL, BIOLOGICAL AND”
CHEMICAL SCIENCES” by Mahesh Kumar Kat aria et al.
The drugs or biologicals for the diagnosis treatment or prevention of a rare illness or condition are ORPHAN DRUGS luckily
“Even though the drugs Intended to treat common diseases where revenue is not expected by pharmaceutical manufacturer are as well categorized as orphan”.

FDA (USA) is the world’s first nation to enact on jan28, 1983 the “ORPHAN DRUG ACT” other nations followed with some modifications. India do not have such act even then drugs controller general of India considers applications made under name of “ORPHAN DRUG” with waiver of some procedures giving good financial relief to applicant or pharmaceutical Industry.
Now let us see how FDA defined ‘orphan disease “an orphan or rare disease may be defined in use one that affects less than two LAKH people in the USA

OR

“One that affects greater than 02 LAKH people but for which there is no expectation that the cost of development of drug and making it available will be recovered from sales of that drug to poor affected population”

“CLASSIFICATION OF ORPHAN DRUGS”

TYPE      DETAIL                                  EXPECTED                            AVAILABLE
                                                                                                PROTITS                                               MEDICTION
I.            little or no                                                   poor                                            Inadequate
              Commercial
              Benefit

II. Commercial good to Inadequate
Benefit excellent

III.       For rare disease that                                         Variable                                       Adequate
              Can be currently
              Treated

IV.        Un profitable for                                              Variable                                       do
              Common disease
V.        Orphan for both                                             Variable                                        Variable
           rare and common
              Disease

Recollecting once more “ORPHAN DRUGS” are defined as drugs intended to treat either a rare disease or a wide spread disease where manufacturer cannot expect to make profits drugs and vaccines for tropical diseases are orphan drugs because patients suffering from these diseases although numbering tens of millions are too poor to pay the price of medication.

By studying above classification table it is difficult to get sponsors for group I and III mentioned above .

Fortunately our proposed research falls under category II because we have large number of patients with TB; Malaria; female infertility; obesity; diabetes mellitus. RABIES definitely falls under orphan disease because in India as per W.H.O estimates rabies deaths are about 20,000 annually. Globally definitely less than two LAKH patients.

If any manufacturer or manufacturers a medicine to cure clinical rabies he will be the first person to do so in the world so also to treat ‘SNAKE POISONS’ etc; etc but that rare credit goes to concerned.

CONCLUDING

When there is no specific proven medication people resort to “quackery”.
‘ORPHAN DRUGS’ manufacture eases getting license, yet this also has to pas the same path like any Allopathic product such as studies on pharmacokinetic and pharmaco dynamics; dosing, stability; safety and efficacy, only we will get some monetary concessions; phase I; phase II trials burden are lessened, to encourage research momentum, there are concessions in phase III also; As 1000 patients may not be available in a short time. As any new study needs widest publicity; motivation; readiness to give compensation in case something goes wrong. But in our proposed research we are not trying anything new, as all medicines in “Ayurvedamu” exist from times immemorial recounting if the allopath wants trial he has to take services of an expert from Ayurveda as co investigator is mandatory that’s we have to do.

FINAL CONCLUSION IN WHAT TO DO? IN OUR PROPOSED CASE

We “Will utilize our Indian drug’s and cosmetics act 1940 chapter IV A – schedule –C rule (33) schedule (EEC) which reads as” Restriction on their own patients, and for manufacturing small quantities for Examination, test or analysis”. That is we can go ahead by taking help of a P.G. Ayurvedic doctor as co investigator that’s all.
THE PATENTS ACT 39 OF 1970
LATEST AMENDMENT ACT [15OF 2005]

Useful for new comers who wants to apply for “Patent”

Is your proposed research is patentable or not? Firstly what is Patent?

A . Under senior 3(m) of above act
“Patent means a right granted to a person who has invented a new and useful article or improvement of an existing article or new process of making an article….”

Q. How long is a patent maximum duration lasts?
A. Under section 53 of (Amendment act of 2005) act, twenty years. After that anybody can copy it.

Q. Whether ‘Ayurvedic formula’ which is existing in old books patentable.
A. No, under section (3) subsections d, e, j ‘p’- for the simple reason, that they one not ‘New Inventions’.

Q. That means any formula can be copied by anyone?
A. Yes, as per above law.

Q. That means ‘CHYAVANA PRASH’ maximum setting ‘DABUR” general health tonic can be manufactured by anyone?
A. Yes.

Q. Then may efforts may go waste?
A. May be there is a need to meet an advocate who knows paten’s law my views are only to my knowledge goes as per book.

Q. In that case I will apply my drug as a ‘new’ not “copied”.
A. In that case you have to undertake all (5) phases of Allopathic drug research namely phases 0,1,2,3,4.

Q. Can I sell that “drug” for bone fractures in the market after I confirm in animals at least it is effective?
A. For marketing you need license your central or state’s “drugs controller” under from 24D drugs and cosmetics rules 1945, read with = R/W rule 153, you have to apply to above Department under

“Application for grant of license to manufacture for sale of Ayurvedic --------drugs” which comes under drugs and cosmetics act 1940 with drugs & cosmetics rules 1945 with amendment rules of 2006.

Q. Here also there are obstructions.
A. 1. Yes you have to overcome them by proving
a) yours is “old drug” only under section 3(a) of the 1st schedule as your formula is mentioned in serial No.11, and (40) above schedule; under drugs and cosmetic act 1940. serial 11,40 names of Ayurvedic books.
2. As per law you have to make an application for examination test analysis under section 34 of above act R/W rule 160A this is to be applied in form No.47.

Q. As per rule 160A, drugs & cosmetics act 1940.
A. Under form 47, above rule from medicine comes under “Choornam” Ayurvedic serial No.7 R/W serial No34 (a) plant based medicine.