CRITICAL ANALYSIS OF CLAIMS IN DRUG PROMOTIONAL LITERATURE AVAILABLE TO MEDICAL PRACTITIONERS

Abstract

Context: Objective: To ascertain whether the pharmaceutical companies are following the World Health Organisation (WHO) criteria for Ethical Medicinal Drug Promotion 2015 and Organisation of Pharmaceutical Producers of India (OPPI) Code of Pharmaceutical Marketing Practices, 2019 and to what extent. Also, to evaluate the therapeutic claims made by them in their drug promotional literature (DPL) and to classify them. Methods: DPL brochures were collected from different pharmaceutical companies from various medical practitioners and assessed for ethical promotion based on guidelines. Therapeutic claims made by them were classified as authentic, exaggerated, controversial, false, misinterpreted, and ambiguous. Results: A total of 100 DPLs were collected and critically analyzed for authenticity of the content. It was observed that the majority of the DPLs did not comply with the criteria mentioned in the WHO Criteria of Ethical Promotion 2015 and the OPPI Code of Pharmaceutical Practices 2019. International non-proprietary names and the brand name were mentioned by 100% of DPLs. The amount of active ingredients and approved therapeutic indications were mentioned by (99%) and (96%) respectively. The dosage form or regimen was mentioned by 87% of DPLs. Criteria like side effects, precautions/contraindications, and major interactions were mentioned in 28%, 29%, and 14% respectively. Based on the therapeutic claims 23% of the DPLs were found to be authentic and the remaining 77% were extravagant. Conclusions: This study enabled us to find out to what extent the pharmaceutical industries follow the standard criteria for DPL and evaluate the claims made by them. The majority of the DPLs did not follow ethical guidelines and were inadequate in terms of their adequacy, quality, and reliability.