A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials

Fernandes, Swapnil Dylan; Vadakkepushpakath, Anoop Narayanan; Castelino, Lovely Joylen; Charyulu, R. Narayana

doi:10.1016/j.sapharm.2018.03.061

Cited by 15 publications

(15 citation statements)

References 12 publications

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“…Later, animal studies with Thalidomide proved that no highest dose of Thalidomide can kill the animal. Due to this, the company sold the drug by saying that suicide is not possible with Thalidomide and proving it to be the safest drug (Dylan Fernandes et al, 2019).…”

Section: Figure 1: Pharmacovigilance Servicesmentioning

confidence: 99%

A review of pharmacovigilance

Dhingra¹,

Tanwar²,

Sharma³

et al. 2022

jpadr

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Introduction: Pharmacovigilance involves more than spontaneous reporting, and is more than just evaluating marketed medications. It has grown from a minor component of drug control to a major activity and expanded its scope to encompass the assistance for patient safety during clinical trials by ensuring adequate informed consent and institutional review boards (ethical committees); development of a safety profile for proper use of a new molecular entity and appropriate communication of that information to a range of relevant stakeholders; selection of the first safe dose for use in humans based on pharmacologic data obtained in animal studies; development of a safety profile. This study implicates the growth of pharmacovigilance in assessing the safety of drugs. Methods: The subsequent information was obtained by reviewing the data from earlier published material. The obtained information was evaluated, compiled, deconstructed, reassembled, interpreted, and conclusions were reached. Results: The supply of data necessary for assessing the advantages and dangers of medicines is, first and foremost, a scientific task. Good pharmacovigilance practice must be created to guarantee that data is gathered and used correctly for the intended purpose. Conclusion: Pharmacovigilance has grown into an essential part of drug control. Signal management protocols ensure that surveillance operations monitor the produced product through collaborative actions with manufacturing specialists, analyze benefit-risk management and inspection readiness maintenance as a corporate culture process.

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Section: Figure 1: Pharmacovigilance Servicesmentioning

confidence: 99%

A review of pharmacovigilance

Dhingra¹,

Tanwar²,

Sharma³

et al. 2022

jpadr

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“…The current form of the GCP has been developed through a constitution and a constitution, as discussed below. (10)(11)(12)(13)(14) The Federal Food and Drug Act 1906: -The object of this act was to prevent the manufacture, sale or distribution of consonant or wrong brand or drugs. However, the act was compromised because of a great declaration that the manufacturer had made in relation to the drug, not to mislead the Court, that the act was not extended to cosmetics and was considered dangerous drugs was not given the right to restrict the use.…”

Section: Issn: 2320-5407mentioning

confidence: 99%

Good Clinical Practice in Pharmacovigilance

Devi¹,

Kumar²,

Jeet³

et al. 2022

IJAR

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Clinical research is a mechanism or a process that provides convincing evidence that the new treatments or therapies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of medicine. Good Clinical Practice (GCP) is an ethical and scientific quality standard for designs, operations and recordings involving the participation of human subjects. Accompanying the Guidelines pledges to the public that the ethics, integrity and welfare of humans participating in the trials are protected. India has experienced distinct opportunities for clinical trials for clinical trials compared to ethical patients, major medical institutions with fewer and more equipped investigators and fewer patient voices than regulated countries, with larger patient counts. However, our Indian guidelines were needed to ensure a uniform standard of clinical research across the country and to provide data for registration for new drugs before use in the human population in India. Junctions guidelines were developed by a complete committee set up by CDSCO with clinical experts. This article explains the importance of good clinical practice from an Indian clinical research perspective, while defining and outlining the goals and objectives of the GCP. It addresses the historical events that led to the emergence of good clinical practices and examines the current scenario with respect to the application of GCPs in clinical trials in India. Finally, the article addresses the challenges to maintaining a best and competitive system and will suggest a way forward to increase the credibility and efficiency of good clinical practice in clinical research.

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“…Although the Indian market is an appropriate ground for clinical research [7,8] , the developing Indian clinical trial industry was affected by noncompliance with regulations and specific reports of unethical clinical trials like those described above [9][10][11] . Thus, Indian government authorities have recently sought to address these issues by establishing regulative clinical trial review mechanisms based on intensive investigation, media attention [13] , NGO involvement [10] , and Supreme Court hearings [14] .…”

Section: Historymentioning

confidence: 99%

India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review

Vennu¹,

Saini²

2020

ijps

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Medical companies consider India is above other countries worldwide as an alternative nation for clinical trials due to easily available sources and infrastructure. However, the developing Indian clinical trial industry has been negatively affected by noncompliance with regulations and by reports of unethical trials. Several studies on Indian clinical trial regulations have been conducted and various articles have been published, but only a few researchers evaluated awareness of investigators and members of the ethics committee about previously amended regulations. No study evaluated the knowledge of researchers on the new drugs and clinical trial rules issued in 2019 and also its impacts. Understanding the knowledge of Indian researchers on new drugs and clinical trial rules, including its effect is crucial to determine whether the trials are being conducted in compliance with the new rules and regulations. Thus, this review aimed to evaluate India's clinical trial regulatory changes based on the existing literature, Indian researcher's knowledge of the recent changes, and assessment of the impact of the new 2019 regulations, elaborating upon clinical trials in both the global and the Indian context.

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A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials

Cited by 15 publications

References 12 publications

A review of pharmacovigilance

A review of pharmacovigilance

Good Clinical Practice in Pharmacovigilance

India's Clinical Trial Regulatory Changes, Indian Researcher?s Awareness of Recently Changed Regulations, and the Impact of the New Drugs and Clinical Trial Rules: A Review

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