Ayurveda – ‘Yes’ to Side Effects, Though ‘No’ tp Pharmacovigilance

The aim of pharmacovigilance is to improve patient care and safety in relation to drug use. As the use of Ayurvedic medicine in India and abroad is increasing day by day, the need of rigorous pharmacovigilance of these Ayurvedic medicines is also increasing. Especially, the presence of toxic metals in numerous Ayurvedic medicines and adverse reactions after using them as reported by few scientific studies, point towards the lack of pharmacovigilance in Ayurvedic medicine.

Since 1978, more than 80 cases of lead poisoning associated with Ayurvedic medicine use have been reported worldwide. In one study, the authors experimented with 70 such medicines manufactured in South Asia and sold in Boston, Massachusetts stores in 2003, and found that 20% among them contained lead, mercury, and arsenic. The amount of these toxic metals was all higher than regulatory limits. According to a report published in the Journal of the American Medical Association (JAMA) in 2004, one-fifth of both US-manufactured and Indian-manufactured Ayurvedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic. The study further explored that few Indian-manufactured rasa shastra (the practice of adding heavy metallic components in Ayurvedic formulations) medicines distributed by US Web sites contain extremely high concentrations of lead and mercury, around 100 to 10000 times greater than acceptable limits. The primary reason behind this is – according to the tradition these medicines are made with bhasmas, which are prepared with various forms of metals including mercuric sulfide, lead sulfide, arsenic sulfide, arsenic trioxide etc. For example, Ekangvir Ras, a popular medicine prepared by rasa shastra process, is made with lead and mercury. Due to such practical scenario the patients with Ayurvedic medicine-associated lead poisoning commonly undergo endoscopy for abdominal symptoms or bone marrow biopsy for anemia before they receive a correct diagnosis.

Unlike ancient times, in this era the production and the sale of Ayurvedic drugs have become transformed into a full-grown industry. Thus, the risk of such negligence in pharmacovigilence is manifold in today’s world. However, the regressive mindset and the obsession of Ayurvedic practitioners are the biggest challenge in introducing pharmacovigilance in Ayurveda. Even their attitude toward adverse reactions of Ayurvedic medicines and reporting these to proper authorities are pathetic. In a survey conducted among 80 vaidyas, 14 refused that these medicines could produce adverse reactions. Among the rest 48 physicians admitted that they had seen ‘unexpected’ reactions after administration of Ayurvedic drugs in their practice. However, only 14 among these 48 reported these reactions.

Moreover, lack of proper methods to study drug safety problems have not evolved adequately in Ayurveda. Similarly, lack of quality assurance and control in manufacture on Ayurvedic medicine create significant loopholes in diagnosing adverse reactions. Another concern regarding this is the huge proportion of small-scale informal sector manufacturing and selling of Ayurvedic drugs. This makes it nearly impossible to identify the medicine which is causing the adverse reaction. According to a survey conducted by the Department of Clinical Pharmacology, TNMC & BYL Nair Ch. Hospital, Mumbai, among 154 requests of adverse reactions to Ayurvedic medicines the exact ingredients of only 22 formulations were known to the researchers. The rest 132 were from the informal sector – dispensed by the ‘doctor’. In addition to this, information related to adverse effects is scattered. Many related publications are not even from peer-reviewed journals and the quality of them is also questionable. However, the real irony is – even if we ignore the presence of this informal sector manufacturing, one may found 100 books describing different Ayurvedic medicines containing over 100000 recipes for medicines. Same herb grown in different regions, seasons, or soil conditions can have vastly different quantities of active compounds. Thus it is hard to manufacture the same type of herbal remedy every time, thereby affecting quality and efficacy, if any.

If Ayurveda were a science this would not be the situation. The lack of pharmacovigilance is deliberate, because even under AYUSH India has not conducted any systematic review of any of the systems under it. The lack of Randomised Control Trials (RCTs), i.e., the clinical trials in which a drug’s effectiveness is tested against a placebo, is also very prominent. The obsession with Ayurveda is equally unscientific like the Ayurveda itself, because its proponents do not even want to consider a simple thing that ancient texts were written a long time ago, and the environment has changed a lot since. This puts the relevance of Ayurveda in today’s time in front of serious questions.

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