Analysis of package inserts of anti-diabetic medications in India


  • Deepak Ramadas Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre, 82 EPIP Area, Whitefield, Bangalore, India
  • Ananya Chakraborty Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre, 82 EPIP Area, Whitefield, Bangalore, India



Package inserts, Antidiabetic, Drug information


Background: Package inserts are printed leaflets accompanying marketed drug products and contain information regarding safe and effective use of drug according to regulatory guidelines. Package inserts are also known as prescription drug label or prescribing information. Need for the study: information’s given in package inserts are suboptimal and can lead to medication error. This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic drugs in India.

Methods: Around 146 package inserts were collected from pharmacies located at different areas of Bangalore. They were analysed based on criteria mentioned in Schedule D of drug and cosmetic act 1945.

Results: Out of 146 package inserts, 56 (38%) belongs to grade A (including all injectable preparation) and remaining 90 (62%) belong to grade B. none of package inserts belong to grade C. Information in package inserts were inadequate in several aspects for example, they had unclear instructions about generic name of other ingredients used, about handling, side effects, shelf life, paediatric and geriatric use and guidelines for use of the drugs.

Conclusions: The study concludes that the information provided in the package insert is not relevant for safe and effective use of medications. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of drug and cosmetic Act, 1945.


Joubert P, Lasagna L. Patient package inserts: nature, notions a needs. Clinical pharmacology and therapeutics. 1975;18:507-13.

Hollister LE. New ideas about drug labels. Clinical pharmacology and therapeutics. 1973;14:309-13.

The Drugs and Cosmetics Act and Rules. Ministry of Health and Family Welfare, Government of India. 2003:312. Available at copy%20of%201.%20d & cact121.pdf. Accessed on 15 March 2013.

Medication adherence: making the case for increased awareness. Available at Briefing_Paper.pdf. Accessed on 16 April 2013.

Ramachandran A, Snehalatha C, Latha E, Vijay V, Viswanathan M. Rising prevalence of NIDDM in an urban population in India. Diabetologia. 1997;40(2):232-7.

Ramachandran A, Das AK, Joshi AR, Yajnik CS, Shah S, Kumar KMP. Current status of diabetes in India and need for novel therapeutic agents. JAPI. 2010;58:7-9.

Joubert PH, Skene D. Attitudes of private medical practitioners towards package inserts and other drug information sources. S Afr Med J. 1984;66:306-7.

Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol Ther. 2006;44(1):8-13.

Curran WJ. The drug package insert: useful information or the practice of medicine. American Journal of Public Health. 1972;62:435.

Friedman CP, Romeo D, Hinton SS. Healthcare decisions and product labeling: results of a consumer comprehension study of prototype labeling for proposed over the counter cholestyramine. American Journal of Medicine. 1997;102:50-6.

Bawazir SA, Abou-auda HS, Gubara OA, Al-Khamis KI, Al-Yamaniet MJ. Public attitude toward drug technical package inserts in Saudi Arabia. J Pharm Technol. 2003;19:209-18.

Morris LA. Patient package inserts: a new tool for patient education. Public Health Reports. 1977;92(5):421-4.




How to Cite

Ramadas, D., & Chakraborty, A. (2017). Analysis of package inserts of anti-diabetic medications in India. International Journal of Basic & Clinical Pharmacology, 5(5), 2240–2243.



Original Research Articles