Conformity of Package Inserts Information to Regulatory Requirements

Abstract

ABSTRACT Background: Accurate and reliable information regarding drugs is essential for safe and effective use of drugs. It is not possible for the clinician to refer research articles every time for complete updates. In such situations, package inserts (PIs) form an authentic information for the doctor and patient. The study was intended to assess the information completeness and precision of PIs using the criteria laid down by, sections 6.2 and 6.3 of Schedule D (II), Schedule Y of Drugs and Cosmetic Act (1940) and Rules (1945). Materials and Methods: PIs of different formulations were collected from various departments, and also local and regional chemists. The information adequacy was done by 25 checklist proposed by the Indian Drug and Cosmetic Act (1940) and Rules, 1945 under sections 6.2 and 6.3 of Schedule D and Schedule Y. A score of “1” was given, if information was present, and “0” if there was no information. Information adequacy scores also calculated. Results: A total of 207 PIs were analyzed. Majority of PIs belong Grade B category of drug information (174). Generic name, composition, posology and method of administration, undesirable effects, contraindications, drug interactions, special precautions, legibility, storage and contraindications during pregnancy and breast feeding were mentioned by nearly all. Gaps were observed in handling instructions, influence on person’s self-driving and machinery operation capabilities, pharmaceutical incompatibilities, shelf life, excipients and Pharmacokinetic and dynamic information not updated regularly. Conclusion: The current study shows that there is still inadequacy of particulars regarding drug information. Hence, it is essential to establish proper uniform standards for the currently available PIs. An absolute and flawless PI should provide complete information. This requires continuous and constant effort from manufacturer and regulatory authorities to promote safe and rational use of medicines.