Ayurveda is a traditional medical system that originated in India. It aims to integrate and balance the body, mind, and spirit to help prevent illness and promote wellness. Due to many reasons, Ayurveda medicines have become popular world over in last decade. According to a survey conducted by the NCCAM in the USA showed that about 751 000 people in the United States had ever used Ayurveda and 154 000 people had used them within the past 12 months. [1] From Japan to west cost of USA Ayurveda medicines are consumed by various ways and means like online shopping, directly from chemist shop as Over the counter product or as prescription from a Vaidya or Doctor.

In ancient times, the Ayurvedic physicians prepared medicines for their patients themselves. Today, only a handful of practitioners follow this practice and production and sale of Ayurvedic drugs has become formalized into a thriving industry. Manufacture and marketing of Ayurvedic drugs is covered by the Drugs and Cosmetics Act, 1940. [2] Broadly speaking, two categories of medicines labeled as "Ayurvedic" are available in the market: firstly, classical Ayurvedic formulations, which are as per descriptions in Ayurveda Samhitas (e.g., Kutajarishta, Chandraprabhavati, etc.) and secondly patent and proprietary formulations made of extracts of herbs. [3] Among them at least 55 to 65% patent medicines are prescribed by the allopath doctors, who have very limited knowledge of Ayurveda Pharmacology.

There are around 8000 licensed Ayurvedic pharmacies and the approximate turnover of this industry is Rs. 4500 crore, which accounts for nearly a third of the total pharmaceutics business in India. [4], which can be considered a very handsome amount for anyone’s curiosity or Apathy.

Many questions are now being raised by the scientific and non scientific community world over regarding the documentation of safety and efficacy of Ayurveda Medicines. A couple of studies done in USA have raised very serious questions in this regards.

According to drug and cosmetic act, 1940 the Ayurvedic drugs, which contains herbs like Ahipena (Papaver somniferurn Linn), Arka (Colotropis gigantean), Bhallataka (Semecarpus anacardium Linn. f.) Bhanga (Cannabis Sativa Linn.), Danti (Baliospermum montanum Mall. Arg.), Dhattura (Datura metal Linn.),Gunja (Abrus), Jaipala (Croton tiglium Linn.),Karaveera (Nerium indicum Mill.), Langali (Gloriosa superba Linn.), Parasilka Yavani (Hyocyamus inibar Linn)., Snuhi (Euphorbia neriifolia Linn.),Vatsanabha (Acontium chasmanthum), Vishmushti (Strychnox nuxvolnica Linn.), Shringivisha (Acontium chasmanthum); and the drugs which contains metals or minerals like Arsenic, Mercury, or lead can not be sale as OTC product. But due to lack of proper implementation of this law, many products are sold without prescription of a qualified Vaidya.

There is a popular misconception that Ayurvedic medicines are devoid of adverse reactions. According to a survey One-Fifth of Internet-Available Ayurvedic Medicines Contain “Toxic” Metals. Following are examples of few popular drugs which contain any of the above said drugs but unfortunately are being taken as self medication by the patients:

• Aarogyavardhini Rasa
• Bruhad or Laghu Suvarna Vasant Malini Rasa
• Chandraprabha Vati
• Laxmivilas Rasa
• Mahayograj Guggulu
• Makardhwaja Rasa etc.
• Panchamrita Parpati
• SamirPannaga Rasa
• Simhanada Guggulu
• Swasakuthar Rasa
• Tamra Bhasma
• Tribhuvan Kirti Rasa
• Trivanga Bhasma
• Vaat Vidhvamsana Rasa
• Yoga raja Guggulu

However, the Charaka Samhita, a classic text book of Ayurveda, describes all the adverse reactions to medicines when they are prepared or used inappropriately. Attention is given to factors like the physical appearance of the part of the plant to be used (Prakriti), its properties (Guna), actions (Karma; Prabhava), habitat (Desha), season in which it grows (Ritu), harvesting conditions (Grahitam), method of storage (Nihitam) and pharmaceutical processing (Upaskritam), which must be considered while selecting the starting material that goes to form the medicine. [5]

Similarly, Charaka also describes, elegantly, several host-related factors to be considered when selecting medicines in order to minimize adverse reactions like the constitution of the patient (Prakriti), age (Vayam), disease (Vikruti), tolerance (previous exposure) (Satmya), psychological state (Satwa), digestive capacity (Ahara-shakti), capacity for exercise (Vyayama Shakti), quality of tissues (Sara), physical proportions of the body (Sahanan) and strength (Bala). [6]

Interestingly, classical Ayurveda prescribes metals and minerals as medicines given as Bhasma (incinerated mineral formulations) or in combination with plants as herbo-mineral formulations (e.g., Aarogyavardhini). Manufacturing procedures for these medicines are stringent, and adverse reactions are described when precautions are not taken while manufacturing and administering these medicines. [7] Although these medicines are widely used in India, doubts about their long-term safety come up due to the presence of toxic metals in them [8] and there are reports related to adverse reactions. [9]

If a patient has ever felt any of following unexpected signs/ symptoms, then it may be observed/ considered as adverse drug reaction:

• Abortion, miscarriage
• Uterine hemorrhage.
• Addiction.
• Birth defects.
• Bleeding of the intestine.
• Cardiovascular disease
• Deafness and kidney failure
• Death, sedation in children
• Dementia
• Depression or hepatic injury
• Diabetes
• Diarrhea
• Erectile dysfunction
• Fever
• Glaucoma
• Hair loss and anemia
• Headache
• Hypertension
• Insomnia.
• Liver damage
• Drowsiness or increase in appetite
• Stroke or heart attack
• Suicide, increased tendency

Nearly 21 percent of the Ayurvedic medicines tested were found to contain detectable levels of lead (most common), mercury, or arsenic. All metal-containing products exceeded one or more standards for acceptable daily metal intake. The prevalence of metal-containing products did not differ significantly by country of manufacture. Rasa Shastra products were more than twice as likely as non-Rasa Shastra products to contain metals, and several Rasa Shastra medicines manufactured in India could result in lead and/or mercury ingestion 100 to 10,000 times greater than acceptable limits. Although manufacturers of 75 percent of the toxic metal-containing products claimed they used Good Manufacturing Practices or metal testing, such claims were not associated with a lower prevalence of toxic metals. The investigators did note that products from members of the U.S.-based American Herbal Products Association had a lower prevalence of toxic metals. [10]

In reply to these questions Charaka says that, "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". [11]

Ministry of Health, Government of India has taken such queries and questions rose by such researches and have started “National Pharmacovigilance Program for Ayurveda Siddha and Unani drugs”

Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. [12] Generally speaking, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:

* identifying new information about hazards associated with medicines
* preventing harm to patients.

The head quarter of this program is Gujarat Ayurveda University, Jamnagar and any health care professionals like ASU Doctors / Dentists / Nurse / Pharmacists etc. can report the adverse drug reaction. Even if you are not a health Professional, you may report such adverse drug reactions with the help of any health Professional. You need to fill a very simple form available at http://www.avpayurveda.com/pv.html. Or one can write to Pharmacovigilance cell, I.P.G. T. & R.A; Gujarat Ayurved University, Jamnagar ¬Gujarat 361 008 India or you can call on + 91 - 288 – 2552014; can Fax: + 91 - 288 - 2676856 or email at deanipgt@ayurveduniversity.com. All consumers / patients and reporters information will remain confidential. It is requested to report all suspected reactions to the concerned, even if it does not have complete data, as soon as possible.

For reporting you need to List of all ASU drugs including drugs of other systems used by the patient during the reporting period with details like Medicine Name, Manufacturer, Batch no., Daily dose, Route of Administration, Date Starting, Date Stopped, and Reason for use you should provide brief details of the suspected ASU medicine as much as you can. Like Composition of the formulation / Part of the Drug used, Expiry date if any, Remaining part of the drug / Product label, Adjuvant, Drug consumed under medical supervision or as self medication.

The patient's identity is held in strict confidence and protected to the fullest extent. Program staff will not disclose the reporter's identity in response to request from the public. Submission of report doesn't constitute an admission that, medical personnel or manufacturers or the product caused or contributed to the reaction.

For more details please contact:
The coordinator, National Pharmacovigilance Resource Centre for ASU Drugs I.P.G.T & R.A., G.A.U., Jamnagar, Gujarat - 361 008 E-mail: nprcasu@gmail.com [13]

Reference:
1. Available from: http://nccam.nih.gov/health/ayurveda/ 
2. Malik V, editor. Drugs and Cosmetic Act, 1940, "4th Chapter", Part I, 14th ed. Lucknow: Eastern Book Company; 2002. p. 37-44.
3. Dahanukar SA, Thatte UM. Can we prescribe Ayurvedic drugs rationally? Indian Pract 1998;51:882-6.
4. Available from: http://indianmedicine.nic.in/html/manufactures/manufactuer.htm#ad 
5. Acharya Jadavji Trikramji, editor. "8 th Adhyaya" Charak Samhita. 5 th ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2001. p. 275
6. Acharya Jadavji Trikramji, editor. "8 th Adhyaya" Charak Samhita. 5 th ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2001. p. 276
7. Pandit Kashinath Shastri, editor. "2 nd Adhyaya" Rasantarangini. 11 th ed. New Delhi: Sri Jainendra Press; 1994. p. 22-4.
8. Saper RB, Kales SN, Paquin J, Burns MJ, Eisenberg DM, Davis RB, et al . Heavy metal content of Ayurvedic herbal medicine products. JAMA 2004;292:2868-73
9. Parab S, Kulkarni RA, Thatte UM. Heavy metals in herbal medicines. Indian J Gastroenterol 2003;22:111-2.
10. Available from: http://nccam.nih.gov/research/results/spotlight/082808.htm 
11. Acharya Jadavji Trikramji, editor. "1 st Adhyaya" Charak Samhita. 5 th ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2001. p. 23
12. Available from: en.wikipedia.org/wiki/Pharmacovigilance 
13. Available from: http://www.avpayurveda.com/pv.html 
14. Available from: http://www.ijp-online.com/article.asp?issn=0253-7613; year=2008; volume=40; issue=7; spage=10; epage=12;aulast=Thatte