PHARMACOVIGILANCE IN AYURVEDA


Ayurveda as the name suggests "Science of Life" is an indigenous system of medicine practicing in the indian subcontinent since centuries. In this system, medicines made of herbals, minerals and its combinations were used for internal administration and also for external applications which is included under Panchakarma (five modalities of treatment procedures-which is done both externally as well as internally). Usually ayurvedic medicines are prepared not from a single medicinal plant or from a single mineral, it is from a combination of many plants or minerals, also single plant extracts or mineral extract are available. Ayurveda not only aims in curing the disease of the diseased but also it gives importance in maintaining the health of a healthy individual mentally as well as physically, as what World Health Organization defines “Health is merely not the absence of disease”. This implies how much the system gives importance to the Health management. The importance of pharmacovigilance in ayurveda arises in this context, that there is a need to ensure the scientificity of each and every drug either externally or internally administering to the patients, that there is no adverse reactions or side effects for these medicines.

Ayurveda Treatments

Regarding the origin of ayurvedic system of medicine, it is believed to be having no origin. Classical reference says that Lord Brahma recollected ayurveda. So, there is no clear idea regarding the scientificity of medicines mentioned in those classical texts, the practitioner follows. About 80% of Indians used to follow ayurvedic medicines one or other ways Now a day’s its popularity is also increasing, with a common belief that it has no side effects, hence it is natural in origin, even though Classical Text clearly mentions, “Poison can also act as a medicine if administered properly and in the same way medicinal plants can also act as a poison if administered improperly.” 

Doctor Consultation

If we consider hundreds of years ago, the physician himself used to prepare medicines for the patients, but current scenario is different, the way of production of medicines is changed, previously it was prepared in one or two doses of medicines at a time, i.e.; patient will get freshly prepared medicines, but now a day’s it is prepared in bulk quantity for long term uses. Based on classical reference, under the Drug and Cosmetics Act 1940, many ayurvedic Pharmaceutical companies such as Kottackal, Vaidyaratnam etc are preparing and marketing their medicines, either in the classical form or in the form of Ayurvedic Proprietary medicines. Many medicinal plants which are mentioned in the texts are not available now, so instead of the unavailable plants, they use some adulterants (Medicinal plants which are similar to the original drug) in the preparation of medicines or sometimes ignore that particular medicinal plant.  And also for long term uses some preservatives are adding up, that may or may not alter the chemical combinations of the medicines, which in turn affects the efficacy of the medicine, even though the manufacturers claim that the medicine is effective as what mentioned in the texts.

In a study done by Ajanal and et al titled, “Ayurvedic Pharmacovigilance study”, shows that symptoms like skin rashes, diarrhea, vomiting or nausea, headache, abdominal pain, and constipation are seen commonly during the administration of ayurvedic medicines.

A few in their case studies are

  • Aragwadadi Kashaya – causes Skin rashes.
  • Shadadhauta grtha – causes Skin rashes.
  • Shatapushpa (Anthem sowa) – oral administration causes diarrhea.

Panchakarma related adverse reactions are more frequent in their study than the oral administration of medicines. When considering the proprietary medicines, the combinations are more complicating. They generally select a combination of medicinal plants mentioned in classical texts that mentioned in the context of a particular disease. For example, Cervilon is a medicine manufactured by AVN Ayurveda pharmaceutical company which is indicated for Cervical Spondylitis and other similar conditions. This medicine has no classical reference available. The company claims that they have done some studies for preparing this medicine and is very effective.

New Plant and New Medicine

In India, there are a number of Pharmaceutical companies which are in the business such as Himalaya, Gufic, Atrimed... etc and are producing a number of classical as well as Proprietary medicines. For example, Liv 52 (for Liver diseases), Pilex (for Hemorrhoids), Sallaki (extract of Boswellia serrata for joint related disorders). The company claims 100% effectiveness of the medicine after their studies, with no reported side effects.

Ayurveda International Report

As our Indigenous system of medicine is gaining more and more popularity in the world, considering the safety and efficacy of the medicine practicing, Department of Ayush, under Government of India, launched a programme called National Pharmacovigilance Programme for ASU (Ayurveda, Siddha and Unani) in 2007, December under the sponsorship of WHO, in Institute of Postgraduate Teaching & Research in Ayurveda, Jamnagar which remains as the main centre for this programme. All the practioners were asked to report all the adverse reactions they notice during their practice to this centre. Unfortunately, how many Ayurveda, Siddha or Unani practioners were aware about this programme remains as a big question.

As all the ayurvedic practioners as well as the Ayurvedic Pharmaceutical Companies are very much important in the growth of our science Ayurveda, it is very much important to ensure the safety of all the medicines available in the market. It must be devoid of any adverse reactions and side effects. For that reporting of all these Adverse events are much more important. And thereby our science will grow towards the world.

Author: Dr Arathy R Krishnakumar, BAMS, Mannam Ayurveda Co-Operative Medical College. Pandalam, Pathanamthitta-Dist, Kerala.

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