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Hierarchy of Pharmacovigilance Program

A three tier structure comprising Pharmacovigilance:

  1. National Pharmacovigilance Co-ordination Centre (NPvCC)
  2. Intermediary Pharmacovigilance Centres (IPvCs)
  3. Peripheral Pharmacovigilance Centres (PPvCs)

All India Institute of Ayurveda, New Delhi is the National Pharmacovigilance Co-ordination Centre (NPvCC) for implementation of the pharmacovigilance program for ASU & H Drugs. The NPvCC will receive inputs in terms of suspected ADRs from the Intermediary Pharmacovigilance Centres (IPvCs), which will initially include:

  • National Institute of Ayurveda, Jaipur
  • Institute for Post-Graduate Teaching & Research in Ayurveda, Jamnagar
  • National Institute of Unani Medicine, Bengaluru
  • National Institute of Siddha, Chennai
  • National Institute of Homoeopathy, Kolkata

Pharmacovigilance is the science dedicated to reduce the risk of drug-related harms to the consumers. Looking into the conditions prevailing in the present scenario, it is high time to deliberate regarding the concerns over traditional and classical Ayurvedic, Siddha, Unani and Homoeopathy products and practices. Thus, the program is initiated to collect, collate and analyze data to establish evidence for clinical safety of ASU & H drugs in a scientific manner for documenting clinical evidence of safety and to undertake surveillance of misleading advertisements of ASU & H drugs for regulatory actions.

The National Pharmacovigilance Co-ordination Centre (NPvCC) will undertake the pharmacovigilance activities under the guidance and technical support of Indian Pharmacopoeia Commission (WHO Collaborating Centre for Pharmacovigilance), Ghaziabad and Concerned programme officers at WHO Country Office-India, New Delhi. The National Pharmacovigilance Co-ordination Centre (NPvCC) in consultation with the Pharmacopoeial Commission of Indian Medicine and Homoeopathy (PCIM&H), if required, shall conduct the Causality Assessment of the signals received from the Intermediary Pharmacovigilance Centres (IPvCs) and intimate to the Ministry of AYUSH regarding confirmed ADRs and misleading advertisements to enable suitable action.

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Ministry of AYUSH, Government of India, New Delhi has initiated the Pharmacovigilance Program for ASU & H drugs

The All India Institute of Ayurveda,
New Delhi is the
NPvCC

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NPvCC Supported by
WHO

Operational Framework for implementation of Pharmacovigilance Program

In order to implement the Pharmacovigilance scheme in systematic order and to develop a proper Adverse Drug Reactions (ADR) reporting system and monitoring of the progress, constitution of the following committees for Pharmacovigilance Programme has been recommended by the PAC –

Steering & Monitoring Committee:
  • Head, DCC, Ministry of AYUSH
  • Director/Coordinator from NPvCC, AIIA
  • Coordinator from IPvC
  • Representative from CDSCO
  • Representative from IPC
  • Representative from PCIM&H
Technical Advisory Committee:
  • Chairman of Scientific Body of PCIM&H
  • Chairmen of APC, UPC, SPC and HPC.
  • Head, DCC, Ministry of AYUSH
  • Representative from IPC
  • Representative from CDSCO
  • Pharmacology expert from AIIMS/ ICMR
  • WHO representative of Pharmacovigilance programme (Technical Officer dealing with medicines and pharmacovigilance in WHO country office)
  • Director/Coordinator from NPvCC
Central Signal Detection & Causality Assessment Committee:
  • Coordinator of NPvCC
  • AYUSH clinical expert
  • Pharmacy expert of AYUSH system
  • Pharmacology / Toxicology expert

Director
NPvCC, AIIA

Prof. Dr. Tanuja Nesari, MD (Ayu) PhD is professor and head of Department of Dravyaguna at the All India Institute of Ayurveda, Delhi, India. She is one of the leading experts for Ayurvedic clinical herbal pharmacology and dietetics.

Message from Director NPvCC, AIIA

The use of traditional medicines continues to expand rapidly across the world and many people now follow traditional systems of medicines for their health care. However, adverse events that are being reported give a negative impression regarding the use of such traditional practices. The safety of herbal medicines has become a major concern to both national health authorities and the general public. The number of adverse reactions to Ayurveda, Siddha, Unani & Homoeopathy (ASU & H) drugs reported in the National Pharmacovigilance in India is negligible. Strong belief that traditional medicines are safe contributes to a large extent to this situation. Lack of knowledge about the concept and importance of pharmacovigilance in ASU & H practitioners is compounding to this matter. Thus, to generate awareness and to analyze possible causes of adverse events, it has been planned to establish National Pharmacovigilance Program.

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Director
NPvCC, AIIA