An analysis of adherence to the World Health Organisation guidelines pertaining to drug promotional literature by pharmaceutical firms

Salma Malik, Tejus Anantharamu, M. Fadil Salmani, Sapna Pradhan, A. G. Mathur


Background: Pharmaceutical companies used Drug Promotion Literatures (DPLs) as a major tool to advertise their new products. World Health Organization (WHO) has set some guidelines for promotion of drug literature. Thus, this study aimed to evaluate various DPLs for their accuracy and credibility as per WHO ethical criteria.

Methods: This was an observational and cross-sectional study. Total 100 drugs advertisements published in various medical journals were collected from the library of the college. Advertisements were selected based on inclusion and exclusion criteria. The selected advertisements were evaluated based on the WHO ethical criteria for drug promotion.

Results: From 100 advertisements, 73 were single drug whereas 27 were fixed drug combinations. Antimicrobials (16%) were the most promoted advertisements. Only 28% of the advertisements carried references to support their claim. Out of which majority (91.78%) were from journal articles. The generic name, brand name, names of active ingredients, manufacturer, distributor and dosage regimen were mentioned in majority of advertisements. Drug interactions (12%), contraindications (22%), precautions (24%) and side effects (22%) were least mentioned in the advertisements.

Conclusions: It was observed that none of the advertisement followed all the guidelines laid down by WHO. Pharmaceutical companies should follow ethical regulatory measures to promote their product in various journals. The regulatory authority must ensure the pharmaceutical companies to follow ethical guidelines for publishing various drug promotional literatures.


Drug advertisements, Indian medical journals, WHO criteria of drug promotion literature

Full Text:



Van Norman GA. Drugs, devices, and the FDA: Part 1: an overview of approval processes for drugs. JACC: Basic Transl Sci. 2016 Apr 25;1(3):170-9.

Ganashree P, Bhuvana K, Sarala N. Critical review of drug promotional literature using the World Health Organization guidelines. J Res Pharm Pract. 2016;5(3):162-5.

Mullard A. 2017 FDA drug approvals. Nat Rev Drug Discov. 2018;17(2):81-5.

Jacob NT. Drug promotion practices: A review. Br J Clin Pharmacol. 2018;84(8):1659-67.

Pascal Iloh GU, Chukwuonye ME. Drug promotion in a resource-constrained Nigerian environment: A cross-sectional study of the influence of pharmaceutical sales representatives on the prescribing behaviors of medical practitioners in Abia State. Arch Med Health Sci. 2017;5(2):215-22.

Ethical criteria for medicinal drug promotion. World Health Organ (online). 1988;13:1-22. Available at:

Charan J, Yadav P, Saxena D, Kantharia ND. Drug advertisements published in Indian Medical Journals: Are they ethical? J Pharm Bioallied Sci. 2011;3(3):403-6.

Korenstein D, Keyhani S, Mendelson A, Ross JS. Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PloS One. 2011;6(8):233-36.

Jaykaran, Saxena D, Yadav P, Kantharia ND. Drug promotional literature distributed by pharmaceutical companies: Do they provide enough. J Pharmacol Pharmacother. 2011;2(3):193-4.

Nath S, Bhowmick S, Dutta T, Chowrasia VR, Bhattacharya S, Chatterjee RN, et al. A study of promotional advertisements of drugs in a medical journal: an ethics perspective. Ind J Med Ethic. 2014 Oct;11(4).

Mali SN, Dudhgaonkar S, Bachewar NP. Evaluation of rationality of promotional drug literature using World Health Organization guidelines. Indian J Pharmacol. 2010;42(5):267-72.

Naikwadi SA, Jadhav RB, Patil AP. Critical analysis of Indian drug promotional literature (DPL) using World Health Organization criteria for ethical medicinal drug promotion. ISOR-JDMS. 2017;16(9):49-54.