Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India

Abstract

Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug samples were collected from government drug supply and private practitioners (PPs). Materials and Methods: A total of 100 drugs were selected randomly from schedule H. They were divided into two groups, each containing 50 drugs: (1) drug samples from drug store of a government hospital, manufactured for Gujarat government and (2) drug samples from PPs which are given to them by pharmaceutical companies. Each drug label was checked according to the criteria given under the D & CRs 1945, Section 96, 97. Data entry was done in Microsoft Excel 2013 and analysis was done. Results: Major deficiencies were seen in criteria of pharmacopeia (absent in 8% samples from government supply [GS] and 64% in samples from PPs), schedule (absent in 18% GS samples and 32% in PP samples), warning of schedule (absent in 6% GS samples and 4% in PP samples), Rx (absent in 22% GS samples and 28% in PP samples), red line (absent in 14% GS samples), and drug warning (absent in 84% GS samples and 72% in PP samples). Conclusion: As the study results show lacunae in the contents of the labeling of prescribed drugs in samples from both the groups, there should be strict enforcement of D & CR 1945 and monitoring of drug labels for better and safer use of medicines.

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