Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines.
Materials And Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards of drug promotion laid by the WHO and IFPMA. Data were analyzed using Fisher's exact test.
Results: Out of total 178 DPLs, 103 DPLs were from Indian journals and 75 DPLs were from non-Indian journals. When compared regarding compliance to all the 11 ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, DPLs from indian journals contained significantly less information regarding dosage regimen (P = 0.0096), adverse drug reactions (P = 0.0028), warnings (P = 0.0104) and major drug interactions (P < 0.0001) as compared to non-Indian journals. Compliance to all the five IFPMA criteria was significantly higher in DPLs of non-Indian journals (88%) than Indian journals (39%) (P < 0.0001).
Conclusion: Noncompliance to ethical standards of WHO and IFPMA guidelines is more common in DPLs of Indian journals as compared to non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended.
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http://dx.doi.org/10.4103/0975-7406.180769 | DOI Listing |
Glob Ment Health (Camb)
March 2024
Centre for Mental Health Law & Policy, Indian Law Society (ILS), Pune, India.
Background: Informed by the UN Convention on the Rights of Persons with Disabilities, the Indian government replaced the 1987 Mental Health Act with the transformative "Indian Mental Healthcare Act, 2017" (IMHCA 2017), which gained presidential approval on April 7, 2017. While the new act aligns with CRPD guidelines, emphasizing the promotion, protection and realization of complete and equitable human rights, legal capacity, equality and dignity for persons with mental illness, it has faced diverse criticism from various stakeholders, particularly psychiatrists. This study systematically explores the critiques and apprehensions expressed by psychiatrists regarding the IMHCA 2017 using available published resources and assesses these criticisms within the context of CRPD guidelines.
View Article and Find Full Text PDFCureus
February 2022
Division of Pediatric Infectious Diseases, Department of Pediatrics and Child Health, Section of Internal Medical Sciences, Faculty of Medicine, Kocaeli University, Izmit, TUR.
Introduction As in many other countries, healthcare workers (HCWs) have been identified as the priority group for vaccination in Turkey for they are in close contact with not only patients with COVID-19 to whom they provide treatment but also asymptomatic individuals with COVID-19 infection while inoculating COVID-19 vaccines. As a result of this prioritization, they will always be in the limelight and regarded as role models for personal and parental acceptance of COVID-19 vaccines. Methods Turkish healthcare workers (n=1,808) were contacted and invited to fill out an online questionnaire between December 27, 2020, and January 14, 2021, in order to reveal their approaches to COVID-19 vaccines and vaccination.
View Article and Find Full Text PDFIndian J Cancer
November 2021
Ex-executive Editor, Indian Journal of Cancer.
Background: The editors of the Indian Journal of Cancer (IJC) have not, so far, objectively analyzed the editorial processes involving author, referee, and editor data of the journal. Hence, we aimed at doing so in this audit.
Methods: We retrospectively analyzed manuscripts submitted to the IJC from April 1, 2020, to May 31, 2020, for data related to the peer-review process.
Epilepsia Open
March 2021
Eisai Inc., Woodcliff Lake, NJ, USA.
Objective: This post hoc analysis assessed the efficacy and safety of adjunctive perampanel in patients (aged ≥ 12 years) with focal seizures (FS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS) in India.
Methods: Centers in India were identified from six double-blind, randomized, Phase II and Phase III studies of adjunctive perampanel (2-12 mg/day) and their open-label extensions (OLEx). Efficacy assessments included median percent change in seizure frequency per 28 days, 50% and 75% responder and seizure-freedom rates.
J Pharm Bioallied Sci
July 2016
Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
Objectives: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines.
Materials And Methods: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria.
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