Good Pharmacovigilance: Accountability in Ayurvedic Companies
Journal name: Ancient Science of Life
Original article title: Good Pharmacovigilance Practice: Accountability of Ayurvedic Pharmaceutical Companies
The ANSCI is a peer-reviewed, open-access journal focused on Ayurveda and traditional medicines. It publishes original research, reviews, and literary studies linking traditional knowledge with modern science, covering disciplines like botany, ethnomedicine, pharmacology, and clinical research.
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Original source:
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Rohit Sharma, R. Galib, P. K. Prajapati
Ancient Science of Life:
(A quarterly multi-disciplinary scientific research journal in Ayurveda)
Full text available for: Good Pharmacovigilance Practice: Accountability of Ayurvedic Pharmaceutical Companies
Year: 2017
Copyright (license): CC BY-NC-SA
Summary of article contents:
Introduction
The manuscript discusses the pressing need for improved pharmacovigilance practices related to Ayurvedic medicines in India. It highlights the significant gap in the systematic documentation of adverse drug reactions (ADRs) associated with these products. The National Pharmacovigilance Program (NPP) aims to ensure the safety and efficacy of Ayurvedic drugs; however, the authors note that the low reporting rate of ADRs—less than 1% in India compared to the global average of 5%—is concerning. This underreporting is attributed to various factors, including a lack of awareness and training among physicians, which informs the risk associated with Ayurvedic drugs.
The Role of Medical Representatives in Pharmacovigilance
A critical element explored in this study is the role of medical representatives (MRs) from Ayurvedic pharmaceutical companies in educating physicians about the importance of reporting ADRs. A survey conducted among 277 Ayurvedic practitioners revealed a dismal 0.4% of respondents indicated receiving information on the need to report ADRs for newly promoted products. Additionally, none of the physicians reported being provided an ADR reporting form, highlighting a significant fail in communication concerning drug safety and monitoring. This lack of information and training suggests that pharmaceutical companies are not adequately prioritizing pharmacovigilance in their marketing strategies, placing patient safety at risk.
Conclusion
The findings advocate for the urgent implementation of comprehensive pharmacovigilance measures within the Ayurvedic sector, emphasizing the need for accountability among pharmaceutical companies and MRs. Recommendations include mandatory ADR reporting by manufacturers, aggregate safety reporting, and enhanced training for MRs on the significance of pharmacovigilance. Collectively, these measures could lead to stricter regulations and better safety monitoring of Ayurvedic medicines. Addressing these concerns not only ensures greater safety for patients but also promotes the responsible commercialization of Ayurvedic products, fostering trust in alternative medicine practices.
FAQ section (important questions/answers):
What is the main focus of the article?
The article discusses the accountability of Ayurvedic pharmaceutical companies regarding good pharmacovigilance practices, specifically the need for better reporting of adverse drug reactions (ADRs) associated with Ayurvedic medicines.
What challenges are highlighted regarding ADR reporting in India?
The article mentions a low ADR reporting rate in India, with less than 1% reporting. It attributes this to physician reluctance, lack of awareness, and inadequate pharmacovigilance training among Ayurvedic practitioners.
What recommendations are made for improving pharmacovigilance?
Recommendations include prompt ADR reporting by manufacturers, conducting drug safety audits, and training marketing representatives to communicate the importance of monitoring ADRs effectively to healthcare professionals.
What was the primary finding from the survey conducted?
The survey found that only 0.4% of Ayurvedic physicians received information about ADR reporting from marketing representatives, indicating a significant gap in ensuring that physicians are aware of pharmacovigilance practices.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Good Pharmacovigilance: Accountability in Ayurvedic Companies�. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
A drug refers to a substance used for medical treatment, aiming to cure or alleviate symptoms. In the context of pharmacovigilance, it highlights the importance of monitoring adverse drug reactions (ADRs), especially concerning Ayurvedic medicines, which may lack systematic documentation and safety evaluations, raising safety concerns for patients.
2) Medicine:
Medicine encompasses various systems and practices aimed at maintaining or restoring health. In this context, Ayurveda, an ancient Indian system, plays a significant role. Due to insufficient pharmacovigilance practices within Ayurvedic medicine, ensuring safety and effectiveness of these remedies is crucial to safeguard patient health.
3) Knowledge:
Knowledge refers to the information, skills, and understanding that professionals possess. In the context of pharmacovigilance, the lack of awareness and training among Ayurvedic practitioners about ADR reporting poses a significant challenge to patient safety and effective healthcare delivery, necessitating further education and awareness initiatives.
4) Ayurveda (Ayus-veda):
Ayurveda is a holistic traditional Indian medicine system that emphasizes balance in health. With increasing commercialization, concerns about the safety and efficacy of Ayurvedic drugs, especially regarding ADR reporting, have arisen. Thus, improving pharmacovigilance practices within Ayurveda is essential for regulatory compliance and patient safety.
5) Sharman (Sarma, Sharma, Sarman):
Sharma is the surname of one of the authors contributing to the discussion on pharmacovigilance in Ayurveda. Rohit Sharma's work emphasizes accountability within Ayurvedic pharmaceutical companies and the need for better communication regarding ADR reporting to enhance public safety and trust in Ayurvedic medications.
6) Rasashastra (Rasa-shastra, Rasasastra):
Rasashastra is a branch of Ayurveda focusing on alchemy and treatment with minerals and metals. This field is critical due to the potential risks associated with using herbo-mineral products. Enhanced pharmacovigilance in this area is vital to ensure the safety and effectiveness of Ayurvedic formulations.
7) Bhaishajya (Bhaisajya):
Bhaishajya refers to medicine or therapeutic formulations in Ayurveda. The accurate understanding and use of Bhaishajya are essential in preventing adverse drug reactions. Ensuring the safety of these formulations through pharmacovigilance efforts allows practitioners to deliver effective treatments while minimizing health risks to patients.
8) Kalpana:
Kalpana in Ayurveda signifies preparation or formulation processes for creating medicines. It is important to understand the preparations' safety and efficacy. Through improving pharmacovigilance practices, risk management can be effectively implemented, ensuring that traditional formulations do not compromise patient safety and align with modern scientific standards.
9) Ayus (Ayush):
Ayush stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy, representing India's traditional medicine systems. The regulation and quality assurance of Ayush medicines are critical in pharmacovigilance to mitigate risks associated with their use. Strengthening these systems enhances public health and fosters trust in alternative treatment modalities.
10) Quality:
Quality in medicine pertains to the efficacy, safety, and compliance with established standards. Enhancing quality assurance mechanisms in Ayurvedic pharmaceuticals is necessary to safeguard against unsafe practices, ensure patient safety, and promote the development of reliable Ayurvedic drugs that meet global health standards.
11) Science (Scientific):
Scientific implies the application of systematic methodologies to validate hypotheses or claims. Scientific rigor in the development and evaluation of Ayurvedic formulations is essential to ensure patient safety, efficacy of treatments, and compliance with pharmacovigilance protocols, ultimately elevating the trust and reliability of Ayurvedic medicine.
12) Post:
In this context, 'post' is related to the type of clinical settings in which Ayurvedic practitioners work. Understanding the clinical practice environment is essential for identifying challenges faced by practitioners, including their engagement with pharmacovigilance reporting and the dissemination of safety information regarding Ayurvedic medications.
13) Training:
Training involves education and skill development for professionals. Implementing training programs focused on pharmacovigilance for Ayurvedic practitioners is crucial to improve their understanding of ADR reporting, ensuring they are equipped to monitor and report adverse events effectively, thus fostering a safer healthcare environment.
14) Channel:
Channel refers to the pathways through which information and medications reach practitioners and patients. In the context of pharmacovigilance communication, strengthening these channels is necessary to improve the dissemination of safety data and encourage reporting practices, ultimately enhancing overall patient care in Ayurveda.
Other Science Concepts:
Discover the significance of concepts within the article: �Good Pharmacovigilance: Accountability in Ayurvedic Companies�. Further sources in the context of Science might help you critically compare this page with similair documents:
Informed consent, Systematic documentation, Clinical evaluation, Adverse drug reaction, Drug Interaction, Regulatory Framework, Safety studies, Pharmacokinetics and pharmacodynamics, Vulnerable Population, Therapeutic claims, Ayurvedic pharmaceutical companies, Regulatory Measures, New Chemical Entities, Healthcare professional, Adverse event, National pharmacovigilance program, Quality control system, Good Pharmacovigilance Practice, Pharmacovigilance knowledge.