Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries

Abstract

Background: Appropriate labeling of marketed medicines is necessary to fulfill the regulatory provisions and ensure patient medication safety. This study aimed to assess the primary labeling of medicines manufactured and marketed by Nepalese pharmaceutical industries.

Methods: We assessed the primary labeling of all medicines available at the pharmacy of Chitwan Medical College Teaching Hospital (CMCTH), Chitwan, Nepal, between November 2017 to December 2017. Medicines were assessed as required by Drug Standard Regulation, 2043 (1986 AD) of Nepal. Appropriate classification of all the medicines and content of over-the-counter (OTC) medicines (where certain information should be in Nepali language) was also assessed. Descriptive statistics was performed.

Results: Seven hundred fifty-nine medicines manufactured by 37 Nepalese pharmaceutical industries were assessed. While all pharmaceutical products had the name of the drug (brand), only76.8% of them stated drug quantity. Almost all products were found to declare category of the drug, with only a few (4.1%) mentioning the sub-category. The system of medicine was stated in 9.9% of the products. Active ingredients and their quantity, manufacturer's information, serial number for the production of drug and the date of production, storing methods, and information on the quantity used were mentioned in almost all the products. Similarly, all the products had batch number and the date of expiry. But, 11% of the products lacked the name of pharmacopoeia to which the drug belongs and all the products lacked the serial number for establishment of pharmaceutical industry. Similarly, 5.3% of the products did not list their price, and 2.4% of prescription medicines lacked caution labeling. Unfortunately, the majority of the products (84.4%) did not provide the directions of use. Appropriate drug classification was found in 89.6% of products. None of the over-the-counter medicines totally adhered to the requirements for writing certain information in Nepali language.

Conclusions: Majority of the products did not meet the regulatory standards of primary labeling of Nepalese pharmaceutical products. This study highlights the necessities for improvement from all stakeholders.

Keywords: Counterfeit drug; Labeling; Low-income countries; Nepal; Patient safety; Pharmaceutical industry; Regulatory standard.