Comparison of Indian package inserts in public and private sector: an urgent need for self regulation

Mohini S. Mahatme, Ganesh N. Dakhale, Sachin K. Hiware, Sumit S. Wankhede, Anoop M. Salve, Sachin R. Mahatme

Abstract


Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector.

Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3.

Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively.

Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society.


Keywords


Packet inserts, Therapeutic indications, Pharmaceutical information, India

Full Text:

PDF

References


Ved JK. Package Inserts in India: Need for a Revision. Int J Pharm Res Sci 2010;1:454-6.

Shivkar YM. Clinical information in drug package inserts in India. J Postgrad Med 2009;55:104-7.

Pujari P. Analysis of information provided in drug package inserts in India. Indian J Pharmacol 2011;43:S27.

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

Govt. of India, Ministry of Health and Family Welfare. Drug and Cosmetics Rules 1940. P- 312. Available at http: //cdsco.nic.in/html/Drugs and CosmeticAct.pdf. Accessed 28 July 2012.

Amran S, Ahmed M, Shaheen SM, Morshed SN, Khandakar J, Rahman M, Rahman M, Hossain A. Short communication: a study on the packaging information of essential drug products used at Union and Thana health complex level in Bangladesh. Pak J Pharm Sci 2007;20:327-32.

Suleh A Bawazia, Hisham S Abou- Auda, Othman A Gubara, Khal III Al- Khamis, Mohammed JMS Al- Yamani. Public Attitude towards Drug Technical Package Inserts in Saudi Arabia. J Pharm Technol 2003;19:209-18.

Zaghi D, Maibach HI. Survey of safety and efficacy information in drug inserts for topical prescription medications. Am J Clin Dermatol 2007;8:43-6.

Lal A, Sethi A. Drug package inserts in India. Ann Pharmacother 1996;30:1041.

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