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Objective: To evaluate the package inserts of antimicrobial drugs utilized in a tertiary care Hospital of North KarnatakaMethods: A cross-sectional, observational, prospective study was undertaken to analyze the package inserts of antimicrobial drugs utilized in a tertiary care hospital in North Karnataka for two months. 218 that belonged to antimicrobials were included in our study and analyzed based on criteria mentioned in Schedule D of the Drug and Cosmetic Act of 1945.Results: None of the Package Inserts analyzed by us adhered to the standard guidelines. Legibility, Approved generic name of active ingredients, and Content of active ingredient per dosage was mentioned in all. In contrast, the least mentioned criteria included References (n=2) and Retail price of the drug (n=9).Conclusion: Updating the existing ones and stricter adherence to the PI with the standard guidelines will achieve better quality and, in turn, improve health care in our society, especially by these antimicrobial agents, which can prevent the development of antimicrobial resistance.
RESUMEN
Background: Current classification of medicines in India under Drug and Cosmetic Act into Schedule G, H, H1, X is outdated, evolved through patchwork over the years and needs to be thoroughly updated. The primary aim of the scheduling system is to ensure appropriate access to medicines while balancing public health and safety. India is experiencing a rapid transition with the rising burden of chronic non-communicable diseases where regular access of affordable medicines is critical for chronic disease management to prevent complications. Methods: We analyzed drugs commonly selling across India, through multiple information sources including 1mg drug database, PharmaTrac (AIOCD-AWACS), inventory data from distributors and retailers, performed extensive literature review and expert interviews. We studied different regulatory systems globally to understand best-practices and identify recommendations. Results: We identified series of lacunae in current drug classification system and its implementation. Out of approximately 1,600 commonly prescribed medicines, only 656 are currently covered under the four Schedules. There are multiple overlaps in terms of drug substances covered under these schedules resulting in ambiguity. Conclusions: We have recommended a revised drug classification system that is more comprehensive in coverage and eliminates the overlaps between classes. Moreover, considering the implementation challenges for such a drug classification system in the diverse and fragmented ecosystem in India, we recommend a technology backed platform to help monitor the implementation.