Publication:

Analysis of package inserts of commonly used drugs in obstetrics and gynecology in Jhalawar district: an observational study in Rajasthan, India

Background Package Insert is the primary source of drug information for the patient. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. Studies on package inserts in India had shown that crucial information was often missing, and they lacked uniformity.

Methods 100 oral drugs used in Obstertrics and Gynecology from different brands were collected from big pharmacies located at Jhalawar and available package inserts were analysed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.

Results Out of 100 oral drugs studied, package inserts were found in 72 drugs, most available information in therapeutic indicators was Posology and method of administration (100%) followed by contra-indications (94.4%), use in pregnancy and lactation (83%), interactions (77.8%) whereas less information about antidote and least about ability in driving and use of machine. In pharmaceutical indicators, it is instruction for use (86%), followed by special precautions for storage (76.4%), shelf life in the medical product as packaged for sale (52.8%).

Conclusions This study showed that many information relevant to the safe and effective use of medication was lacking in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.