Central Sector Scheme of Pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy Drugs:

The Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs. Prime objective of the scheme is to develop the culture of documenting adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media.

The scheme intends to facilitate the establishment of three-tier network of National Pharmacovigilance Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCCs) and Peripheral Pharmacovigilance Centres (PPvCC). All India Institute of Ayurveda, New Delhi, has been designated as National Pharmacovigilance Centre. In the initial phase of implementation, five National Institutes of AYUSH are designated as the Intermediary Pharmacovigilance Centres and forty-two (42) institutions of AYUSH having clinical facilities as Peripheral Pharmacovigilance Centres. It is intended to have more such centres across the country and achieve the target of 100 peripheral pharmacovigilance centres by 2020. Representatives of Central Drug Standards Control Organisation as the national drug regulatory authority and the Indian Pharmacopoeia Commission being the WHO Collaborating Centre for Pharmacovigilance in the country are associated in the initiative as mentor and guide.

Pharmacovigilance is more than spontaneous reporting alone and the evaluation of medicines is more than pharmacovigilance. It is the branch dealing with adverse drug reactions (ADRs), their recognition, and reporting. ADR is defined by the World Health Organization (WHO) as a response to a drug that is noxious, unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of a physiological function. Pharmacovigilance is defined by the WHO as a science, with activities that relate to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

The common myth regarding herbal medicines is that these medicines are completely safe and can therefore be safely consumed by the patient on his/her own, without a physician’s prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side effects, or unwanted aftereffects. Hence, AYUSH practitioners and consumers now need to be vigilant about the safety monitoring of drugs in the interest of Public Health.

Pharmacovigilance initiative will facilitate detection of potentially unsafe ASU&H medicines and misleading advertisements for taking regulatory action against them. The Standing Finance Committee (SFC) chaired by Secretary (AYUSH) approved the scheme on November 1, 2017 and subsequently it was rolled out for implementation in the country near the end of financial year 2017-18.

Aims and Objectives :

Aims:

  • Early detection of unknown safety problems
  • Detection of increases in frequency
  • Identification of risk factors
  • Quantifying risks
  • Preventing patients from being affected unnecessarily.

Objectives of PV:

  • Promote a culture of safety awareness and ADR monitoring.
  • Identify signals of unknown ADRs.

Broad Objectives:

  • To foster the culture of AE notification and reporting.
  • To establish a viable and broad-based ADR monitoring program.

Specific Objectives:

  • To create an ADR database for the India population.
  • To create awareness of ADR monitoring among people.
  • To ensure optimum safety of drug product in Indian market.
  • To create infrastructure for ongoing regulatory review of periodic safety update reports.

Goals of Pharmacovigilance:

• The rational and safe use of medical drugs

• The assessment and communication of the risks and benefits of   drugs on the market

• Educating and informing of patients.