Drug promotional literature (DPL) plays a critical role in shaping the perception and utilization of pharmaceutical products within the healthcare industry. DPL includes printed material like flyers, pamphlets, brochures, ads in journals, newspapers, books and also digital content. It encompasses a range of materials designed to communicate the benefits, risks, and appropriate use of medications to healthcare professionals and consumers. Research indicates that well-structured promotional materials can significantly influence prescriber behavior and patient adherence1,2. Pharmaceutical industry spends a huge amount of money for promotion of their products rather on their research and development. In 2005, a pharmaceutical industry in the USA has spent more than 30 billion dollars in marketing and promoting to enlighten the clinicians about their products3. Indian pharmaceutical industry spends almost 10-20% of their sales revenue on drug promotion4. Keeping in view of giving unbiased and complete information related to drugs, World Health Organization (WHO)5 has laid down standard ethical criteria to manufacturers and distributors, the promotion industry, prescribers, and consumer groups. According to the WHO, medicinal drug promotion is defined as “all informational and persuasive activities by manufactures and distributors, the effect of which is to induce the prescription, supply, purchase, and/or use of medicinal drugs.”6, 7 It has been observed in various studies that most of DPLs are not following the ethical criteria and this can lead to irrational drug prescription and utilization. Responsible informative promotion and marketing remains a subject of scrutiny, necessitating reforms to ensure that drug promotion serves the best interests of public health3. As such, understanding the complexities of drug promotion literature is essential for healthcare professionals to navigate its implications effectively. With this background, the present study was conducted with the primary objective of comparing the DPL on the basis of WHO guidelines on ethical drug promotion and analyzing the quantitative aspects of promotion literature. Aims and objectives 1. To conduct a critical review on compliance of drug promotional literature based on WHO criteria. 2. To identify common deficiencies in the information provided in DPL.

Study design and setting This is a cross sectional, observational study done in the department of Pharmacology, Government Medical College, Rajamahendravaram on drug promotional literature collected from the Tertiary care and private hospitals in Rajahmundry. The study was conducted after prior approval from Institutional Ethics Committee (IEC/GMC-RJM/2025/07, DT.28/03/2025). The study was done for a period of three months from March to May 2025. The Study tools included various printed promotional documents sourced from pharmaceutical companies, like flyers, leaflets, brochures, advertisements in various journals, monographs and newspapers were collected. Data was analysed using WHO ethical criteria which includes  Generic name of the drug.  Brand name.  Amount of active ingredient(s).  Approved therapeutic uses.  Dosage form or regimen.  Side effects and adverse reactions.  Precautions, contraindications, and warnings.  Major interactions.  Name and address of the manufacturer or distributor.  Reference to scientific literature. Study criteria Inclusion criteria All the printed drug promotional documents for single drug and drug combinations were included. Exclusion criteria Drug advertisements related to medical equipment, devices, ayurvedic medicines, nutritional supplements, herbal medicines and digital content were excluded. Statistical analysis A descriptive analysis was done to evaluate the compliance of DPLs with established WHO guidelines on ethical promotion. Common deficiencies were identified and categorized. Data was entered in Excel sheet and expressed as percentages.

Out of 500 DPLs collected, 251 were selected based on inclusion and exclusion criteria and analysed. Among the ones excluded, around 80 DPLs showed multiple drugs promoted in a single pamphlet and the rest 60 were duplications. Among total number of DPLs, 92% were of prescription drugs and the remaining 8% were OTC drugs. Majority of DPLs comprised of combination drugs (54.4%) while 45.6% were of single drug promotions. Figure 1 displays various types of printed DPLs collected and 53.6% of them were flyers. Table 1 presents the Analysis of DPLs based on WHO ethical criteria. Majority (98.8%) of the DPLs mentioned generic name, brand name and active ingredient per dosage form. Most (96%) of the DPLs mentioned therapeutic uses and manufacturer details. Only 31% of the DPLs mentioned safety information. Table 1: Analysis of DPLs based on WHO ethical criteria S No WHO ethical criteria Number of DPLs (%) 1 Generic name 247 (98.8%) 2 Brand name 247 (98.8%) 3 Content of active ingredient per dosage form or regimen 247 (98.8%) 4 Name of additive(s) 32 (12.8%) 5 Approved therapeutic uses 240 (96%) 6 Dosage form or regimen 231 (92.4%) 7 Side effects and major ADRs 78 (31.2%) 8 Precaution, contraindication and warnings 75 (30%) 9 Major interactions 70 (28%) 10 Name and address of manufacturer and distributor 242 (96.8%) 11 References to scientific literature 168 (67.2%) As shown in Figure 2, among all the DPLs collected only 26% (65) satisfied the entire WHO ethical criteria. In Table 2, types of claims in DPLs are presented. Most of the claims made in DPLs were emotional (74.8%) followed by efficacy claims(59%). Table 2 : Types of claims in DPLs. Type of claims in DPLs No of DPLs(%) Efficacy 149 (59%) Safety 57 (22.8%) Pharmacokinetic 40 (16%) Emotional 187 (74.8%) Convenience 65 (26%) Pictorial representations Pictures were represented in 78% of the DPLs but only 24% of them were relevant to the given information . Pictorial representations in DPL are depicted in Figure 4. Most of the given pictures were related to gender and medicine.

In view of hundreds of new medications entering the market every year, the pharmaceutical companies promote their drugs through various means of drug promotional literature. Most prescribers depend on DPL for updates on innovative medications introduced into the market. Ideally DPLs should abide by all the 11 criteria laid down by WHO for ethical drug promotion. But in the present study, it was found that majority of DPLs did not meet all the 11 WHO criteria and deficiencies regarding scientific data, claims made and pictorial representation of the DPLs were identified. We noticed that flyers were the most commonly used means to promote the drugs followed by pamphlets and brochures. According to this study, promotion of combination drugs (54.4%) outnumbered single drug promotions which was similar to the study reported by Sekar et al and Mangla N et al[8,9]. Though very least number of fixed dose combinations (FDCs) were suggested by our latest essential medicine list (EML) [10] but more number of FDCs are flooding into the market. Hence the prescribers should consider the rationality of drug combinations before prescribing so as to reduce the risk of ADRs and also the cost of treatment. Analysis of DPLs using WHO ethical criteria showed that 98.8% of them revealed generic name, brand name and active ingredients which was consistent with the study done by Gautam S.R. et al where 100% of DPLs conveyed the same information [11]. It was noticed that only 96% of the DPLs exhibited approved therapeutic uses and 92.4% mentioned dosage form in the present study. Safety information of the promoted drugs such as adverse drug reactions (31.2%), precautions, contraindications, warnings (30%) and major interactions (28%) was given least priority and also written in very small font. These findings were comparable with the findings in many studies like the one done by Jadav SS et al and Phoolgen S et al. [6,12] These findings conclude that pharmaceutical companies are more interested in promoting their brand rather than focusing on the patient safety. Only 67.2% of the DPLs gave a supporting scientific reference to the information provided which was similar to a study done by Sonali et al where only 71% provided the aiding references [13] Retrievability and validity of the references was also questionable in most of the DPLs. When it comes to the name and address of the manufacturer and distributor, it was present in almost all (96.8%) DPLs. About 50% of DPLs were found to be unscientific. Providing up-to-date information and appropriate data on drug safety leads to practice of evidence based medicine and overlooking this matter can result in irrational prescribing which results in wastage of resources and increases disease burden on the patient. As per the current study, antidiabetic drugs (20.8%) were the most promoted drugs followed by NSAIDs (13.2%), CNS drugs (13.2%), antimicrobial agents (12.8%), drugs acting on GIT (12.4%) and drugs acting on cardiovascular system (8%). The findings of this study correlate with the study done by Mistry et al [14]. These drugs are targeted by the pharmaceutical companies in view of increasing prevalence of chronic disease conditions like Diabetes mellitus, CNS diseases and cardiovascular diseases that require lifelong treatment. It was noticed that, among all the DPLs collected only 26% (65) satisfied all the criteria laid down by WHO for ethical drug promotion whereas around 59.4% (149) could fulfill only 6-7 points of the criteria which included brand name, generic name, therapeutic uses, dosage forms and manufacturer details. In the present study, 90% of total DPLs made claims regarding efficacy, safety, pharmacokinetic property, convenience and emotional which correlates with the study done by Mali et al [15]. Among them, majority of claims were of emotional (74.8%) followed by efficacy claims (59%). Safety claims (22.8%) were less. More over these claims were not properly supported by scientific data, which correlates with the study done by Vivek K et al [16]. These alluring and flashy phrases may mislead the prescribers easily. Among the analyzed DPLs, 78% (196) of them exhibited various pictures of medicines, targeted organs, gender, patient and doctor. Most DPLs displayed pictures of medicines (43.4%) and gender wise pictures (44.8% ) but 76% of the total pictures were found to be irrelevant which resembled with the study done by Jadav et al.[6]. DPLs should be made more scientific with research data and Supporting information, such as pictures, should represent the level of significance in relation to the parameters evaluated and helpful to the prescriber to better understand the rationality and arrive at the right medication. While Only 30% of them came out with scientific data presented in figures and tables which were similar to study report of Mistry et al. [14], 18% of them displayed only graphs. Cost of the drug was mentioned by only 6% of the DPLs. Limitations: In this study only printed promotional literature was analysed. The sample size was also small making it difficult to generalize the findings. Awareness of the practitioners regarding accurate and ethical information to be included in the DPLs was not assessed.

Most of the DPLs in the present study, did not fulfil the entire WHO ethical criteria. Irrelevant pictures and misleading claims were given more priority than the safety and scientific data regarding the medications. This kind of unethical drug promotion can lead to poor decision making by the prescribers and irrational drug utilization and it impacts the overall health care system. The health department should be more vigilant and make sure that the pharmaceutical industry adheres to the ethical criteria stated by WHO. In order to achieve Ethical drug promotional activities and rational prescribing, collective efforts of practitioners, pharmaceutical companies and regulatory bodies is required.

1. Gibbons, C. (2019). The Impact of Pharmaceutical Promotion on Prescribing Behavior. *Journal of Health Economics*, 28(2), 134-140. 2. Johnson, R., & Lee, T. (2020). Ethical Considerations in Pharmaceutical Marketing: A Systematic Review. *Clinician Reviews*, 15(3), 45-52. 3. Kornfield R, Donohue J, Berndt ER, Alexander GC. Promotion of prescription drugs to consumers and providers, 2001‑2010. 4. Lexchin J. Drug Promotion in India Since 2000: Problems Remain. Int J Health Serv. 2021 Jul;51(3):392-403. 5. World Health Organization: Ethical criteria for medicinal drug promotion . (1988). Accessed, July 21 ,2025 6. Jadav SS, Dumatar CB, Dikshit RK. Drug promotional literatures (DPLs) evaluation as per World Health Organisation (WHO) criteria. J App Pharm Sci 2014;4:84‑8. 7. 7.Rohra DK, Gilani AH, Memon IK, Perven G, Khan MT, Zafar H, et al. Critical evaluation of the claims made by pharmaceutical companies in drug promotional material in Pakistan. J Pharm Pharm Sci 2006;9:50‑9. 8. Sekar P. Evaluation of the rationality of claims made in drug promotional literature in West Chennai. Asian J Pharm Clin Res 2015;8:107-9. 9. Mangla N, Gupta MC. Evaluation of rationality of drug promotional literature using WHO ethical criteria for medicinal drug promotion. Int J Health Sci Res. 2018; 8(4):55-62 10. WHO model list of essential medicines. Available at https://www.who.int/groups/expert-committee-on-selection-and-use-of-essential-medicines/essential-medicines-lists. Accessed on 22 May 2025. 11. Gautam, S. R., Chugh, P.K., Sah, R. K., & Tripathi, C. D. (2017) Critical appraisal of drug promotional literature using WorldHealth Organisation guidelines. International Journal of Basic & Clinical Pharmacology, 6(8),2014–2019. 12. Phoolgen S, Kumar SA, Kumar RJ. Evaluation of the rationality of psychotropic drug promotional literatures in Nepal. J Drug Discov Ther 2012;2:6‑8. 13. Rode SB, Salankar HV, Katole NT, Deshkar AT, Dadmal AA, Parate SV. Critical Appraisal of Drug Promotional Literature in Accordance With WHO Guidelines. Cureus. 2022 Aug 3;14(8):e27644. 14. Mistry VR, Kanani NJ, Thacker KS. A critical evaluation of promotional drug literatures available with prescribers at a tertiary care teaching hospital in Gujarat, India. Int J Basic Clin Pharmacol 2022;11:167. 15. 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. 16. Vivek K, Deolekar P, Naseem A, Langade DG, Yadav P. A critical review of the drug promotional literature published in scientific medical journals and available at outpatient departments: A cross-sectional observational study. Cureus 2022;14:e31283.