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NATIONAL PHARMACOVIGILANCE PROGRAMME FOR AYURVEDA SIDDHA, UNANI & HOMEO DRUGS
Pharmacovigilance has been defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems. Recently, its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biological, medical devices and vaccines. It was officially introduced in December 1961 in response to the thalidomide disaster. In 1968, the WHO promoted the “Programme for International Drug Monitoring”, a pilot project which was aimed to centralize world data on adverse drug reactions (ADRs). Pharmacovigilance is particularly concerned with ADRs, which are defined as any response to a drug that are noxious and unintended, including lack of efficacy, which occurs at doses normally used for prophylaxis, diagnosis or therapy of disease or for modification of physiological function in the body.
In India, National Pharmacovigilance Programme has been started under the control of Central Drug Standards Control Organisation (CDSCO) in 2003. WHO emphasizes that it should include traditional medicines in Pharmacovigilance (PV) system and has published guidelines on safety monitoring of herbal medicines in 2004. From 2007 to 2018, IPGT and RA, Jamnagar, was designated as the National Pharmacovigilance Resource Centre for ASU drugs in India. At present Homeopathic drugs are also included under this programme and the National center of Pharmacovigilance is at All India Institute of Ayurveda, New Delhi. In order to maintain a proper documentation, to regulate, monitor and control the activities of Pharmacovigilance 3 tier systems were established throughout the country – 1 National Pharmacovigilance centre (NPvCC), 5 Intermediary Pharmacovigilance centre (IPvCC) and 41 Peripheral Pharmacovigilance centre (PPvCC).
Ayurveda, Siddha & Unani (ASU) system of medicines are being practiced in India since ages. In the present scenario certain concerns are raised with regard to the safety and efficacy of ASU drugs. Due to the non-judicial use, use without prescription, guidance or supervision of qualified medical practitioner, a few adverse reactions were reported. Hence the scientific assessment of the ADR’s and adverse events is very much essential. This will meet the demands of the modern world to keep the database for safe use of ASU drugs.
Pharmacovigilance practice is the need of hour for all systems of medicine including ISM to ensure public safety and to promote the development of ASU systems of medicine. It aims to improve the patient care and safety in relation to the medicines as well as medical interventions. It contributes to the assessment of benefit, harm, effectiveness and risk of the medicines, by encouraging their safe, rational and effective use. Hence for the global acceptance of ASU drugs proper education regarding Pharmacovigilance is a must to health professionals so as to encourage them to analyse and report any adverse effects that occurs in a patient.
VPSV Ayurveda College, Kottakkal has been chosen as PPvCC for reporting ADR’S from the Kerala state in 2018. The PPvCC is assigned with a Program Co-ordinator (HOD, Department of Dravyaguna) and a Program assistant for monitoring it’s functioning. They are responsible for collecting adverse events in predesigned suspected ADR reporting form. Information provided in this form is handled in strict confidence and are reported to IPvCC, where causalty analysis is carried out. The information is then forwarded to the National Pharmacovigilance Centre, New Delhi, where it is consolidated, statistically analysed, and later forwarded to the Department of AYUSH.
9447423771 (Dr. N Manojkumar, Program Co-ordinator)
9633669434 (Dr. Haseena K, Program assistant)
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