The Indian Drug Manufacturers' Association (IDMA) has urged the union health ministry to include pharmacovigilance as a topic in the subsection of pharmacology in the syllabus of medical and pharmacy students in the country.
In a White Paper recently submitted to Drug Controller General of India (DCGI) Dr Surinder Singh, the IDMA said that including pharmacovigilance in the syllabus will enable the medical and pharmacy students to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug reactions (ADRs), the manner in which these are detected and monitored, and the related historic and legal frameworks etc.
Spontaneous reporting of ADRs is an important method for detecting new safety issues related to drugs and the best way to increase reporting is by way of educating students, the IDMA said and added that since pharmacovigilance is the best tool to indicate the safety of a drug, its awareness and understanding, must be ensured at all stages for all those associated with the drug industry.
There is an increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. IDMA stressed on the need for implementing new rules so that it could strengthen the existing pharmacovigilane system in the country. Thus education on pharmacoviligance and importance of reporting should be extensively incorporated into medical and pharmacy training to address these issues.
The white paper also focussed on other issues pertaining to industry and laid down suggestions to the authority to ponder on. IDMA stressed that the pharma companies and CRO's must understand and support the need to have an adverse drug reaction registry database at CDSCO.
The white paper suggested that there should be a system devised of analysing ADR drug wise devised by the pharmacovigilance department of the CDSCO and the outcome should be published preferably bi-annually as report to the nation besides forwarding the same to the medical associations.
The paper calls upon practising medical professional to report ADRs and professional associations to be entrusted with task of taking suitable steps to ensure the same. It stresses that guidelines for reporting ADRs by the healthcare professionals should be accessible wherever reporting forms are available.
In a White Paper recently submitted to Drug Controller General of India (DCGI) Dr Surinder Singh, the IDMA said that including pharmacovigilance in the syllabus will enable the medical and pharmacy students to understand issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug reactions (ADRs), the manner in which these are detected and monitored, and the related historic and legal frameworks etc.
Spontaneous reporting of ADRs is an important method for detecting new safety issues related to drugs and the best way to increase reporting is by way of educating students, the IDMA said and added that since pharmacovigilance is the best tool to indicate the safety of a drug, its awareness and understanding, must be ensured at all stages for all those associated with the drug industry.
There is an increasing need for well informed professionals to work in all areas related to the assessment of drug safety and risk-benefit of drug use. IDMA stressed on the need for implementing new rules so that it could strengthen the existing pharmacovigilane system in the country. Thus education on pharmacoviligance and importance of reporting should be extensively incorporated into medical and pharmacy training to address these issues.
The white paper also focussed on other issues pertaining to industry and laid down suggestions to the authority to ponder on. IDMA stressed that the pharma companies and CRO's must understand and support the need to have an adverse drug reaction registry database at CDSCO.
The white paper suggested that there should be a system devised of analysing ADR drug wise devised by the pharmacovigilance department of the CDSCO and the outcome should be published preferably bi-annually as report to the nation besides forwarding the same to the medical associations.
The paper calls upon practising medical professional to report ADRs and professional associations to be entrusted with task of taking suitable steps to ensure the same. It stresses that guidelines for reporting ADRs by the healthcare professionals should be accessible wherever reporting forms are available.
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