SCHE ME FOR PHAR MAC OV I GI LAN CE OF AY USH DR UGS
Why in news?
Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of AYUSH Drugs.
About the scheme
• Objective: To develop the culture of documenting adverse effects & undertake safety monitoring of AYUSH drugs.
• It will undertake surveillance of misleading advertisements appearing in the print and electronic media.
About pharmacovigilance
• It is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Need for Pharmacovigilance
• Quality issues and safety concerns of Ayurveda, Siddha, Unani and
Homoeopathy Drugs raised from various sources.
• For Public Health, it is necessary to oversee the impact of ASU&H Drugs and detect potentially unsafe drugs.
• Requirement of regulating the publicizing of improper drug information
in the form advertisements.
• To ensure usage with prescription and under supervision of a qualified medical practitioner.
• To prevent consumption of these drugs as over the counter drug
• To conduct premarketing safety evaluation as well as post marketing surveillance.
75 ©Vision IAS
• It intends to facilitate the establishment of three-tier network of National Pharmacovigilance Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCCs) and Peripheral Pharmacovigilance Centres (PPvCC) to take up the work of reporting, documentation, analysis, causality assessment of the adverse reactions and events associated with the consumption of AYUSH drugs.
• All India Institute of Ayurveda, an
autonomous body under the Ministry of AYUSH, has been designated as National Pharmacovigilance Centre for coordinating various activities of the initiative.
• The scheme also aims to 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.
About Central Drug Standards Control Organisation
• It is the national drug regulatory authority.
• It is responsible for approval of New Drugs, Clinical Trials in the country and laying down the standards for Drugs.
• It exercises control over the quality of imported Drugs and coordination of the activities of State Drug Control Organisations.
• It provides expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
About Indian Pharmacopoeia Commission
• It is an Autonomous Institution under the Ministry of Health & Family
Welfare.
• It is dedicated for setting of standards for drugs, pharmaceuticals and healthcare devices/ technologies etc.
• It also provides Reference Substances and Training.
While CDSCO has sole responsibility for Periodic Safety Update Reports, Indian Pharmacopoeia Commission (IPC) is in charge of co-ordinating Adverse Drug Reports (ADRs)
Why in news?
Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of AYUSH Drugs.
About the scheme
• Objective: To develop the culture of documenting adverse effects & undertake safety monitoring of AYUSH drugs.
• It will undertake surveillance of misleading advertisements appearing in the print and electronic media.
About pharmacovigilance
• It is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Need for Pharmacovigilance
• Quality issues and safety concerns of Ayurveda, Siddha, Unani and
Homoeopathy Drugs raised from various sources.
• For Public Health, it is necessary to oversee the impact of ASU&H Drugs and detect potentially unsafe drugs.
• Requirement of regulating the publicizing of improper drug information
in the form advertisements.
• To ensure usage with prescription and under supervision of a qualified medical practitioner.
• To prevent consumption of these drugs as over the counter drug
• To conduct premarketing safety evaluation as well as post marketing surveillance.
75 ©Vision IAS
• It intends to facilitate the establishment of three-tier network of National Pharmacovigilance Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCCs) and Peripheral Pharmacovigilance Centres (PPvCC) to take up the work of reporting, documentation, analysis, causality assessment of the adverse reactions and events associated with the consumption of AYUSH drugs.
• All India Institute of Ayurveda, an
autonomous body under the Ministry of AYUSH, has been designated as National Pharmacovigilance Centre for coordinating various activities of the initiative.
• The scheme also aims to 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.
About Central Drug Standards Control Organisation
• It is the national drug regulatory authority.
• It is responsible for approval of New Drugs, Clinical Trials in the country and laying down the standards for Drugs.
• It exercises control over the quality of imported Drugs and coordination of the activities of State Drug Control Organisations.
• It provides expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
About Indian Pharmacopoeia Commission
• It is an Autonomous Institution under the Ministry of Health & Family
Welfare.
• It is dedicated for setting of standards for drugs, pharmaceuticals and healthcare devices/ technologies etc.
• It also provides Reference Substances and Training.
While CDSCO has sole responsibility for Periodic Safety Update Reports, Indian Pharmacopoeia Commission (IPC) is in charge of co-ordinating Adverse Drug Reports (ADRs)
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