Wednesday, 30 March 2011

Pharmacovigilance of Ayurvedic Drugs – A Pragmatic Approach for its Proficient Practice

Ayurveda, one of the most appreciable systems of medicine is making its high perception among common masses across globe on virtue of its fundamental doctrines to treat human with medicine as well as modification in life style, not only account of materialistic criteria but with eliminations of mental critics too.

The commercial component of companies and indefinable individuals involved in business of Ayurvedic medicines lead to several kinds of compromises and corruption causing continuous conditions of critical care for system of Ayurveda from all corners of continents, concomitantly.
The phenomenon of Pharmacovigilance is performed worldwide in conventional system of medicine (modern alias allopath) since more than half centuries to ensure safety and efficacy of different dosage forms of modern medicine. Certainly, there is pioneer contribution of this programme which ascertained withdrawal of many molecules after reports of their adverse drug reactions through pharmacovigilance and post marketing surveillance.

Encouraged by success of these programmes, World Health Organization convinced deptt of AYUSH of Government of India to bring Ayurvedic medicines under set up of surveillance for its monitoring on established parameters of safety and efficacy of a medicine through a Pharmacovigilance programme specially designed for Ayurvedic ,Siddha and Unani Medicines. On 29 September, 2008 National Pharmacovigilance Programme for Ayurvedic Siddha and Unani Drugs was launched by central government recognizing Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar as national resource centre for this programme.

Till date national centre is working with paraphernalia of eight regional centers and with aim of association of each college of systems of AYUSH all across country, all the way through pharmacovigilance cell. In conduction of this programme colossal contribution are being made from research councils of AYUSH namely Central Council of Ayurveda and Research in Ayurveda and Siddha. For acquaintance of pharmacovigilance programme to all stakeholders of Ayurveda namely physicians and teaching fraternity of Ayurvedic institutions, in all CME and RoTP programme of dept of AYUSH, lectures on Pharmacovigilance are being arranged as mandatory schedule. This is apart from the CME held by National Pharmacovigilance center. Moreover, subject matter of Pharamcovigilance has been instituted in under graduate and post graduate syllabus of Rasa Shastra & Bhaishjya Kalpana and Dravya guna.

The specific goals of Pharmacovigilance programme for Ayurvedic medicine are to-

1. Improve patient care and safety in relation to use of Ayurvedic medicines and other interventions.

2. Improve public health and safety in relation to the use of Ayurvedic medicines.

3. Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and

4. Promote understanding, education and clinical training in Pharmacovigilance in terms of Ayurvedic medicines and its effective communication to the public.

Many cases have been reported in recent past regarding adverse drug reactions and interactions of drug –drug, food- drug etc at various national and international forums .Hence, this Pharmacovigilance programme specifically meant for Ayurvedic drugs may serve the cause in understanding of Early detection of hitherto unknown adverse reactions and interactions of Ayurvedic drugs. Detection of increases in frequency of (known) adverse reactions of Ayurvedic drugs. Identification of risk factors and possible mechanisms underlying adverse reactions.

More so ever, for the guaranteed success of Pharmacovigilance programme it is compulsory that Pharmaceutical companies of Ayurveda should promise to each consequent consumers of Ayurveda that they are engaged for every achievable to assure pledged safety and promised efficacy of these medicines .

The accomplishment of any Pharmacovigilance system is in its ability to prevent further adverse reactions by interpretation of information received. Therefore, with salutation we recognize supremacy of a physician in reporting of onset or offset of any ADRs of Ayurvedic Medicine and seek his/her prominent contribution in achievements of the pharmacovigilance programme of Ayurvedic medicines.

To achieve these objectives there is a define process of planning and execution of pharmacovigilance programme of Ayurvedic medicine which may be discussed elaborately in workshop.