Nov 13, 2014

Pharmacovigilance of Ayurveda: Questioning its Efficacy

Dr Dinesh Kumar Jain, Dr Rajkumar Arya
World Journal of Pharmaceutical Research (WJPR), Vol 3, Issue 6, 2014


Ayurveda is based on balance of vata, pitta and kapha in the body. Increase of these humours creates diseases. Removing or calming these humours is the main objective of the treatment in Ayurveda. In Ayurveda, plants, metals, climates, seasons, physical activities are divided in to two groups. They increase or decrease imaginary humours and used accordingly to maintain balance. Astrology, incantations, hymns, mantra-tantra, worship, prayers, emesis, enema, catharsis, cranial catharsis, blood letting are used in treatment. These concepts of Ayurveda are irrational, illogical, unscientific and not supported by knowledge of medical science. Ignorance and silence of medical personnel regarding this crucial concept indicate their dishonesty towards society and science. Pharmacovigilance also includes study of efficacy of drugs. If evidence of ineffectiveness of Ayurveda put in front of Central Government, then Government is ready to prohibit use and manufacture of the Ayurvedic drugs. It is the duty of pharmacologists and medicine specialists to protect the society from the ineffective and useless therapeutic systems.

What is Ayurveda

Ayurveda is an irrational, unscientific therapeutic system and illogical, superstitious life style; represents Indian psyche and Indian culture including use of herbs, metals, diet, panchkarma, astrology, incantations, hymns, religion, rituals, amulets (totaka), mantra-tantra; concepts of supernatural force, spirits and rebirth to improve health and cure diseases by maintaining concentration of vata, pitta and kapha in the body. According to section (3) of Drugs and Cosmetics act1, 1940, Ayurvedic drugs include all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [disease or disorder in human beings or animals and manufactured] exclusively in accordance with the formulae described in the authoritative books of Ayurveda, specified in the first schedule. These books are 57 in numbers. Important books are : Ayurveda Prakasha, Ayurveda Samgraha, Bhaishajya Ratnavali, Bharat Bhaishajay Ratnakara, Bhava Prakasha, Brihat Nighantu Ratnakara, Charaka Samhita, Chakra Datta, Nighantu Ratnakara, Rasa RajaSundara, Rasaratna Samuchaya, Rasa Tarangini, Sharangadhara Samhita, Siddha Yoga Samgraha, Sushruta Samhita, Basava Rajeeyam, Ayurvedic Formulary of India, Ayurveda Sara Sangraha, Ayurvedic Pharmacopoeia of India. Whatever mentioned in these Ayurvedic books can be manufactured, marketed and used therapeutically without any scientific evaluation in India.

Main Principles Of Ayurveda

In Ayurveda, origin of diseases is due to the disturbance of equilibrium of vata (wind), pitta (bile), kapha (phlegm) in the body. Diseases being supposed to be caused by derangements of the humours. Removing or calming the excess humour, is the main objective of the treatment. Diseases are also divided in to asthenic and sthenic respectively caused by depletion or repletion of the humours and are treated with remedies having an opposite effect. The action of drugs may result either in an increase or excitation of the humours or in soothing them. In diseases these humours are either increased or decreased. In Ayurveda, plants, metals, climates, seasons, physical activities are divided in to two groups. They increase or decrease imaginary humours.

The remedies in Ayurveda are divided according to their action on humours, into those (1) which remove the collection of bad humours from the body by panchkarma namely emesis, catharsis, cranial catharsis, enema and blood letting (2) which calm down the excited action of humours without promoting their excretion or discharge. “Sitting on elephant and horse increases pitta and vata. Laborious work decreases kapha. Sleep reduces pitta. Vomiting reduces kapha. Cap and hat on the head reduce vata and Kapha. Dew increases vata and kapha. Darkness reduces pitta and kapha. Sleep reduces pitta. Oil massage reduces vata.

Emesis reduces kapha. Person is sensitive for kapha-dosh in beginning of night, for pitta-dosh in mid night and for vata-dosh in the end of night. Person is sensitive for cough-dosh during childhood, for pitta-dosh during young age and for vata-dosh in old age. Urine of goat reduces vata, pitta, kapha. Urine of cow decreases vata, pitta but increase kapha. Urine of elephant decreases vata but increases pitta and kapha. Urine of horse reduces kapha, pitta but increases vata. Strong sunrays reduce kapha and increase vata. Spring season intensifies kapha but garden, flowers and young females reduce kapha. Autumn season intensifies pitta. Early winter reduces pitta. Rains intensifies vata.

Various plants also reduce or increase these humours. BIJORA, HARAD, SONTH, PIPRAMUL reduce Kaph. CHIRAYATA, NEEM, PIPAR, KACHUR, SONTH, SATAVAR, GILDY KATERI reduce Kapha. PITTAPAPARA, NAGARMOTHA, GILOY, SONTH, CHIRAYATA mixture reduce Vata and Pitta. GILOY, ANDI, ATUSA reduce vata. CHOTI ILAYACHI, PHOOL PRIYANGOO, NAGAR-MOTHA, BER, PIPAL, CHANDAN, LONG, NAGKESAR MIXTURE reduce vata, pitta,"2 In this way plants are classified in to groups arbitrarily. This classification is not based on reasons, systems or logics.

This excess vata, pitta, kapha are expelled from the body by emesis, purgation, enema and impure excess blood by blood letting. Leech and venesection are used for blood letting. Blood letting is used in leprosy, swelling, tumors, eczema, eye diseases, syphilis, liver diseases, spleen diseases, weakness in organs, foul-smelling, sleeping disorders, fever, excess lacrimation, goitre, lymph node swelling around neck.

According to Ayurveda, excess use, misuse, & absence of use of sensory and motor activities in the body also contribute in origin of disease. Many plants are used in Ayurveda to induce emesis, purgation and enema to reduce excess accumulated humours in the body. Anger of God, spirits, sins of previous birth, and entry of spirit in the body also cause diseases and for their treatment, worships, prayers, rituals, amulets, charms are advised. Tantra and totaka are also advised in Ayurveda. "In treatment of epilepsy a string, used for hanging, is burnt and ash is taken with cold water"3 Suppression of the urges for urination, defecation, seminal discharge, flatus, vomiting, eructation, hunger, lacrimation, sleep and deep breathing after exercise are directly responsible for many diseases in Ayurveda. Atharvada is one of the basic source of origin of Ayurveda. The Atharveda deals mainly with witchcraft and magic spells by which enemies and demons could be destroyed. Application of medicines is also accompanied by charms, incantations and magic.

Representative Contents Of Ayurveda, Mentioned In Standard Books

Representative contents of Ayurveda are being given here to show what actually Ayurveda is ? These examples are not exceptions. Ayurveda is based completely on such type of directions. According to Ayurveda, the "source of knowledge of Ayurveda is Brahma. Daksa Prajapati the progenitor first obtained the science of life in its entirety as promulgated by Brahma, the great creator and from him, in turn, the Aswin twins the God Sakra (Indra) acquired it." It indicates knowledge of Ayurveda has been given by Brahma. This belief of devine origin hindered the progress of science because nobody could dare question against Ayurveda.

1. Ayurveda Directs An Illogical, Irrational Life Style.

Ayurveda says- "A woman during menstruation should avoid laughing, weeping, excess speaking, laborious work, use of oil, bath, daytime sleep, running etc. She should sit silently in a corner of room. She should not see her husband during menstruation. If menstruating woman will not take such precautions, her children will suffer with diseases".

2.Ayurveda also directs normal persons.

“Avoid to take sleep during day time. Do not see your image in water. Never enter in water nacked. Do not eat curd in the night. Never give freedom to women and never believe them. By doing excess sexual acts, cough, fever, respiratory problems, weakness, jaundice, tuberculosis etc originate.”

3. Ayurveda gives idiotic concepts about origin of metals.

Ayurveda tells, "After seeing beautiful ladies, Agnideva became excited, his semen fell on the earth and became gold. Copper was originated from semen of Kartikay. Silver was originated from the tears of left eye of Mahadeva. Lead was originated from semen of vasukinag. Continuous use of lead gives power like elephant, cures diseases, prolongs life and delays death. Mercury was originated from semen of shiva. Mercury destroys vata, pitta, kapha and cures all diseases".

4. Ayurvedic concept of fever is ridiculous.

According to this system, "fever was originated from breath of Mahadeva in anger when he was insulted by Prjapati. Anger increases pitta so those plants and activities should be advised which reduce pitta. In fever, worship of Mahadeva is advised. Fever produced by an evil spirit should be managed by torture and worship. Fever induced by stars should be

treated by charity, worship and chanting"5. "Wearing auspicious stones, herbs and certain poisons one secures immunity to attack of fever, according to Ayurveda. By worshiping Vishnu, Brahma, Indra, Agni, Himalaya, Ganga, one conquers fever. By the repetition of prayers, performance of sacrifices and charities, by listening to the recitation of the vedas and by seeing holy people, one soon gets cured of fever"4

5. Causes and treatments of insanity described in Ayurveda is completely unscientific, illogical and represents lack of knowledge

"Possession by the gods, sages, Gandharvas, and the failure in the discharge of observances and vows in the life or previous one are the causes of insanity. The man who evinces superhuman power should be regarded as having the insanity, born of spirit possession. The gods etc. enter invisibly and suddenly in to the body of a man by their innate power. Burnt offering, wearing of magical herbs and talismans, customary rites and austerities, by propitating the gods, cows, brahmanas and the teachers as well as charms and medicines should be used. These patients can be managed by massage, vomiting, diarrhoea; application of heated iron, water, oil on the body surface; whip-lash in lonely house, bite by toothless snakes, terrorizing by lions and elephants and by insulting patients."5

6. Causes and treatment of tuberculosis and leprosy in Ayurveda also indicates inaccuracy of this system

"Suppression of wind expelled from anus, suppression of urination, fasting, jealous thoughts, excess food, absence of food, food taken at irregular time, lift heavy weight, speak loudly, swimming in large rivers, running with horse, rapid dance, excess attraction towards female are causes of tuberculosis. It is also mentioned in Ayurveda, if tuberculosis patients are suffering from diarrhoea or swelling in testes or swelling in abdomen, should not be treated. Tuberculosis patients should be managed by panchkaram"5 "Causes of leprosy are disrespect to brahmins and teachers, eating milk with fish, eating curd with milk, suppression of emesis and urination, exercise after heavy meals. Leprosy is cured by applying HARAD, KARANJ, SARSO, HALDI, BAVCHI, SENDHA NAMAK, and YAYVIANG after mixing and grinding in cow urine."5

7. Causes and treatment of diseases in children, as mentioned in Ayurveda, are 1. Children of those families suffer with diseases where fore-fathers, gods, brahmans, teachers, ascetics, and guests are not worshipped and welcome and in the families where food is taken in broken utensils of bronze. Mahadeva directed BALGRAH (A spirit) to create diseases in children of such families.

2. For treatment in diseases of children, use smokes of these substances after mixing & burning (SANP KE KANCHULI, LAHSUN, CHURANHAR, GHEE, NEEM KE PATTE, BILAV KI VISTHA, BAKARI KE ROAM, MEDASHINGI, VACH SAHAT], worship BALGRAH and use hymn and disenchant to cure diseases in children.

Management of delayed labour according to Ayurveda

(1) Give fumes of burning of slought of black snake around vagina. (2) Apply fumes of MANFAL around vagina. (3) Tie roots of KALIHARI around hand or feet.            (4) Put dry head of dead cow in the house. (5) Tie roots of sugar-cane around waist of female. These all procedures are beneficial for quick delivery.

1. In Ayurveda, many plants are used without scientific basis in treatment of one disease, which is illogical and irrational. For example in one treatment “INDRAYAN, NAGARMOTHA, SONTH, DANTI, JANGI, HARAD, NISOTH, KACHUR, BAYVIANG, GOKHRU, CHITE KI CHHAL TEJBAL, JAMIKAND, VIGHARA, BHILAWE, MIRACH, PIPAL, AANWALA, DALCHINI are used in combination"

2. In the management of snake poisoning. Ayurveda says – "In the cases of snake-bite, patient should bite same snake for the treatment. Hymns and charms are more beneficial to patients of snake-bite than drug treatment. In cases of other poison, patients should be bitten by snake to antagonize effect of one poison by another poison. Blood letting is also a part of management of poisoning"

3. “In VAJIKARAN, a treatment to increase sexual power, (A) eat testes of goat. (B) eat eggs of crab, tortoise or crocodile and drink semen of goat, buffalo, or bull."

4. Highly poisonous plants are used in Ayurveda in toxic doses. “Ayurveda also advises to eat fruits of BHILAWAN, one or two daily, then increase gradually up to 70 fruits daily to cure leprosy and piles and to increase age up to 100 years. One thousand fruits of BHILAWAN can be taken in treatment"6 But what is the reality ? "Taken in larger doses, it produces blisters on the throat and severe gastrointestinal irritation followed in some cases by impending fear of death, dyspnoea, tachycardia, hypotension, cyanosis, dilated pupil, delirium, coma and death within 12 to 24 hours. More than 5 gram of BHILAWAN is

considered a toxic dose. It is considered that 144 grains of the juice of BHILAWAN to be fatal dose. There are many reported cases of death who had taken BHILAWAN fruits orally or apply locally"7 "Similary in Ayurveda, KUCHLA is advised in the treatment of many diseases"8 but it is fatal to humans.

5. One plant is used in many diseases in Ayurveda. One very typical aspect of Ayurveda is that each and every plant, has therapeutic utility. Some plants are being used in many diseases in Ayurveda irrespective of accuracy. “NEEM, Indian Lilac, (Azadi rachta Indica) is used in skin diseases, eczema, small pox, piles, ysentery, plague, fever, malaria, ysentery, leprosy, asthma, cholera, ysentery, muscular injury, abscess, worms infestation, ear infections, eye diseases, nasal bleeding, menstruation problems, paralysis, joint pain, scorpion bite, snake poison, opium poison, syphilis, night blindness, etc.”8

6. Ayurveda also "directs use of tantra-mantra"9. Following are typical examples. (1) In one treatment, tie around neck or waist, nose of Jackal, tongue of crow, umblicus of pig, bronze, mercury, snake poison, and bone of frog.

Take stool of pigeon mix with water of boiled rice in the treatment of menorrhagia.
In diseases of children, where fever, loss of appettite, loss of sleep, loss of desire of milk, complaint of weeping are symptoms. Following mantras are used :
Questions against efficacy of Ayurveda

There are many facts which raise questions against efficacy of Ayurveda -

1. Ayurveda has been originated from Brahm, which indicates philosophical origin. Ayurveda did not take origin by scientific study.

2. Use of hymns, incantations, astrology, religion, in treatment has been discarded today completely. These are primitive concepts, indicate lack of scientific knowledge.

3. The concept of vata, pitta, kapha is not proved by present knowledge of medical science. Principles of Ayurveda are irrational, illogical, unscientific and not based on clinical controlled study. Explanations of Ayurveda are not supported by knowledge of anatomy, physiology, pathology, histology, clinical pharmacology and medicine. Natural urges should not be suppressed as rightly told by Ayurveda but these suppression are not responsible for origin of diseases as wrongly mentioned in Ayurveda. These wrong basic principles have been followed by Ayurveda in its whole literature.

4. Descriptions about (A) origin of metals (B) Causes and treatment of fever, tuberculosis, leprosy, (C) management of delayed labour and snake poisoning (D) Vajikaran, as mentioned in this article are very ridiculous. All Ayurvedic books contain such type of irrational and illogical basis. Such Ayurveda should be discarded for the welfare of human-beings and world.

5. Combination of herbs are used in Ayurveda without isolating and identifying active ingredients. Without knowing active ingredients, knowledge of absorbtion, metabolism, route of administration and knowledge of doses and relation between doses and toxicity is not possible. Dose related responses can not be measured. Therefore assessment of accurate therapeutic utility of Ayurvedic substance is not possible.

6. Different isomers of drug have different pharmacological actions and different therapeutic uses. But according to Ayurveda, single herb can be used in twenty or thirty diseases. It is against the rules of evolution. Evolution gives specificity to different organs of body having different affinity to different chemical molecules.

7. Regarding herbal remedies, "Following queries are raised"10 – (1) These preparations are difficult to standardize, nor can one be sure of their pharmacological activities (2) It is almost impossible to test for the presence of the ingredients mentioned in the herbal preparation (3) The heral combinations offered and dose recommended are not supported by any scientific data. (4) Tall claims are made about their efficacy without adequate scientific data. (5) Herbal remedies previously thought to be innocuous are known to be potentially toxic.

8. It is wrong to say that Ayurvedic substances have no adverse effects. “Canada, United Kingdom, and Singapur have banned the sale of Indian Ayurvedic medicines in their country claiming that they contain high levels of metals like lead and mercury and arsenic posing grave health risks”11,12,13. “Since 1978 more than 80 cases of lead poisoning associated with Ayurvedic medicine use have been reported world wide.”14 “Seventy Ayurvedic medicines manufactured in South Asia and sold in Boston, Massachusetts, stores in 2003, it is found that 20% contained lead, mercury and/or arsenic”15. “One-fifth of both US-manufactured and India- manufactured Ayurvedic medicines purchased via the internet contain detectable lead, mercury, or arsenic.”16

9. “One well reputed pharmaceutical company in India had established research and development unit to get scientific support for herbal medicines. But after continuous work for eight years, research unit has been closed because beneficial results were not obtained.” It was a great disillusionment with the herbal medicines.

10. “In United States of America, herbal medicines have been regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1940. According to this act, herbal medicines are not evaluated by the FDA and these products are not intended to diagnose, treat, cure or prevent diseases.”

11. In the absence of sufficient knowledge of anatomy, physiology, pathology, clinical pharmacology, drug action was based on mere speculation associated with the humoral or similar doctrines. In beginning, all over the world, this was the state of knowledge. In the 16th century, knowledge developed by Vesalius, Harvey, Morgagni and others led to the collapse of the humoral theory. "As the result of these additions to knowledge, based on observations and experiments, new concepts replaced the old speculative doctrines in Europe, while in India the old concepts persist even today as a "system" and instead of being replaced by the newer knowledge, are obstinately held firmly and now a vain attempt is being made to tag on to the old concept the new ones. Thus a medical "system" consisting of incompatibles and partly contradictory views is being advocated and maintained with the Government help for "patriotic" reasons, creating a sort of intellectual dishonesty among the students of the system and leading to confusion of the lay pubic and a great dissipation of the national resources"19. Ignorance and silence of medical personnel regarding this crucial concept indicate their cheating towards society and science. Promotion of this unscientific and useless Ayurveda indicates crime of pharmacologists and medicine specialists. It is very surprising that our academic bodies encourage and support the unscientific policy by establishment faculties for the study of such obsolete ideas.

12. “A ban on the cell of Ayurvedic and other herbal medicines will take effect across Europe from May 1st, 2011 following a European Union directive introduced as a response to growing concern over adverse effects of such alternative medicines. After the ban comes into effect only high quality, long established and scientifically safe herbal medicines will be sold over the counter.”

Study of efficacy is a part of pharmacovigilance

"Good pharmacovigilance practice refers to carefully planned and executed pharmacovigilance activities to minimize toxicity and maximize beneficial effects of drugs and biologicals".21 Unfortunately there is still a confusion on the work of pharmacovigilance. Pharmacologists think that pharmacovigilance is concerned only with the side effects and toxic effects. It is wrong. "Adverse drug reaction or an adverse reaction means a response to a medicine in the humans or animals, which is noxious and unintended, including lack of efficacy and which occurs at any dosage and can also result from an overdose, misuse or abuse of a medicine." Study of efficacy of a substance or a therapeutic system should be the first step of pharmacovigilance. Without sufficient scientific support of efficacy for a system of therapeutics, there should not be any discussion and study of toxic effects, otherwise it will be wastage of time, energy and money and it will create only confusion in medical science.

Duty of pharmacologists and medicine specialists

"Pharmacologists and other medicine specialists are talking of adverse reactions of Ayurvedic preparations in the pharmacovigilance". They never discuss efficacy of Ayurvedic substances. Without clear-cut evidence of efficacy, discussion of adverse effects of Ayurveda is giving wrong massage to Government and society that Ayurveda is efficacious therapeutic system. What we have discussed about contents of Ayurvedic books in this article, clearly indicates that Ayurveda is irrational, illogical, unscientific and useless. Therefore, it is our duty to explore and discuss efficacy of Ayurveda first. We have to protect the society from the dangers being caused by unscientific and useless therapeutic systems. Crores of rupees are being spent on Ayurvedic medical colleges, physicians of Ayurveda and manufacture of drugs. Due to use of ineffective drugs, tuberculosis, leprosy, malaria and other curable diseases are spreading dangerously. Ayurveda is also misguiding the public and society and increasing morbidity and mortality because it is interfering in application of modern medical science. Central Government has power to prohibit manufacture and distribution of drugs. According to chapter 4A, section 33 EED of Drugs and Cosmetic Act 1940, if the central government is satisfied on the basis of any evidence or other material available before it that the use of any Ayurvedic, Siddha or Unani drug is likely to involve any risk to humans or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest, it is necessary or expedient so to do then that government may by notification in the official Gazette, prohibit the manufacture, sale or distribution of such drugs. Drugs and Cosmetics act 1940; also gives protection to those persons who provide evidence against useless therapeutics system to Government. According to section, 37 of this act, no suit, prosecution or other legal proceeding shall lie against any person for any thing, which is in good faith done or intended to be done under this act.

Dr Dinesh Kumar Jain
Associate Professor, Department of Pharmacology, Bundelkhand Medical College Sagar (MP), India.

Dr Rajkumar Arya
Associate Professor, Department of Pharmacology ,Gajra Raja Medical College Gwalior (MP), India.