Knowledge, Attitudes and Practices regarding complex generic drugs among physicians in India: A cross-sectional survey

Abstract Background Complex generics are gaining importance as a affordable alternative to high cost complex drugs. However their successful adoption by end user largely depends in the hands of physicians understanding and confidence towards these products. Despite of the market growth of complex generics, evidence related to knowledge, attitude and practice (KAP) of physician towards complex generics remain limited particularly in India. Therefore the current study assessed KAP and perspectives related to regulatory and quality. Methods An online cross sectional survey was conducted among 100 licensed physician practicing complex generic across 21 states of India. A validated and pilot tested 52 item questionnaire consisting of five domains: knowledge, attitude, practice, regulatory and quality perspective of complex generics were assessed and employed for collecting responses. Data were analyzed using descriptive and inferential parametric statistics such as Pearson’s correlation and multiple linear regression analysis in Jamovi software. p -value less than 0.05 were considered as statistically significant. Results Most participants (65% of physicians) have shown moderate awareness about the product and merely 16% had an in-depth knowledge about what is meant by complex generics. Even identification of the products under the class of complex generics were correctly identified by only 2% respondents although they are prescribing these drugs. Approximately 49% expressed neutral confidence regarding the quality, safety, and efficacy of complex generics. More than 70% of the participants highlight the need for more stringent regulatory scrutiny and educational initiatives. Knowledge showed significant positive correlation with all the other four domains such as attitude, practice, regulatory and quality perspective with all p vale < 0.001. Conclusion In the current exploratory survey study, the participants demonstrate positive attitude towards regulatory and academic initiatives, however moderate awareness and limited knowledge as well as confidence in prescribing complex generics. From the non-probability sampling approach, these findings concluded that limited access to information on scientific and regulatory data and also knowledge gaps has reduces physician confidence in prescribing these medicines. Strengthening academic foundation, awareness training activities, dissemination of regulatory and clinical evidence will help in improving prescribing confidence and market acceptance which ultimately support affordable healthcare access.