Abstract

DRUG PACKAGE INSERTS IN INDIA: CURRENT SCENARIO

Abul Kalam*, Siraj Anwar, Ambrin Fatima

ABSTRACT

Aims: Drug package inserts are the bedrock of methods used to inform people about their medicines. Previous studies had shown that package inserts available with drug products in India need improved content and uniformity. Hence, the present study reviewed the information available in drug package inserts of India and assessed the improvement over last few years. Method and Material: We evaluated 50 package inserts supplied along with drug products marketed by pharmaceutical companies in India, for their presentation and completeness as described in Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules of India, 1945. Results: We found upto 71% compliance with the inclusion of important sections specified in the Drugs and Cosmetics Rules, 1945. All the package inserts contained the section on indication and adverse drug reactions (ADRs), and information on ADRs was complete in 97% of the inserts. The categorisation of the ADRs according to the organ system and reporting of ADR frequency had also improved. However, sections like instructions for use, antidote in case of overdose and potential impact on driving were missing in majority of package inserts. Conclusions: Although package inserts in India have improved over the years, optimizing them for the patient as end user is essential. Considering the level of literacy and diverse language variability of Indian population, it is crucial to improve the comprehensiveness of package inserts.

Keywords: Medicines information package insert; Package leaflets; Patient information; instructions for use.