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Adverse Drug Reaction of Ayurveda Medicines
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.
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).
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.]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 and there are reports related to adverse reactions.
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.
* Birth defects.
* Bleeding of the intestine.
* Cardiovascular disease
* Deafness and kidney failure
* Death, sedation in children
* Depression or hepatic injury
* Erectile dysfunction
* Hair loss and anemia
* Liver damage
* Drowsiness or increase in appetite
* Stroke or heart attack
* Suicide, increased tendency
Many 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.
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".
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. 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.