That Ayurvedic drugs are safe due to their natural origin is a popular conception, but it is true to the extent that many are used as foodstuffs and deserve the classification Generally Recognized as Safe - GRAS. References in the Ayurvedic classics to possible adverse reactions to certain Ayurvedic medicines alert us against accepting this concept as universal, however. This is particularly true if medicines are not prepared properly, or if preconditions for their administration are not respected by both physician and patient, which will increase the possibility of an ADR occurring. Charak Sutra Sthana 26 warns that substances contrary to deha dhatus will be antagonistic (virodha) towards them. Such antagonism may result from properties, combination, processing, place, time, dose etc. or natural composition.
In Ayurveda, diet (ahar
) is as important for cure as medicine. The texts state that an ailment can only be cured by following proper diet (pathya
). In this context, Charaka lists dietary incompatibilities between particular foodstuffs[22
- Fish and milk
- Honey and ghee in equal quantity
- Hot water after taking bhallataka
- Kampillaka cooked with butter milk.
Antagonistic food may cause ADRs
Ayurveda’s overall approach is holistic in that it aims to return a patient’s physiology to its natural state of balance. Effects of Ayurvedic drugs are considered in terms of their ability to return the physiology to its natural, holistic state. Improper dose schedules either in quantity or duration may lead to ADRs. Similarly, for any herbal or herbo-mineral formulations used in overdose or for excessive time periods.
The pharmacovigilance program promises to close the gap between Ayurvedic drugs’ potential and reality. Some Ayurvedic citations use flowery language to describe certain formulations’ therapeutic value, for example, the effect of Grahani Kapat Rasa on dysentery / diarrhea; similarly for certain vajikarna formulations. There may be a huge gap between claimed and reality, suggesting assessment of their genuine value under pharmacovigilance.
An important aspect of the pharmacovigilance program is formulations’ economic evaluation, which may be carried out at any stage in a health care strategy’s life cycle. Data from such studies differs from that for clinical trials, and requires business-style analysis. Such economic evaluation studies must be considered an integral component of a decision analysis system using multiple criteria and methodologies from different disciplines, that helps the program achieve its multifaceted targets.
When new drugs are developed, the pharmacovigilance program with its social perspective requires economic evaluation of all aspects of their use in treatment, including side effects, adverse reactions, and their additional treatment costs, in addition to routine therapeutic evaluation. The pharmaceutical industry also needs to take responsibility for these added facets of pharmacovigilance.
The program may also be applied in cases where medicines are unavailable, unaffordable, unsafe, or improperly used; or where conflict of interest with manufacturers occurs, or in poorly monitored clinical trials, when patient recruitment is unethical or informed consent is inadequate. According to the December, 2008 notification of Rule 170 of the Drugs and Cosmetics Rule, 1945, many clinical trials are planned in future.[23
Successful implementation of the pharmacovigilance program, requires pharmaceutical companies to demonstrate to both regulators and consumers that they are doing everything possible to assure drug safety, including developing more effective ways to manage drug safety data. Efficient analysis of data from adverse event reporting systems, and internal and external data sources are needed to respond to regulators’ safety inquiries or other issues.[24
The program was reviewed on 21 January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU). More recently, on 15 February, 2010, the Secretary, Department of AYUSH chaired an evaluation meeting of the Pharmacovigilance Program for ASU Drugs, new initiatives to implement the program more effectively. The evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. NPRC, Jamnagar, presented details of 103 ADRs reported from all over the country and their causality assessment. This is a matter of some concern. More recent developments include constitution of pharmacovigilance centers at all Ayurveda teaching institutes and research centers.