Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries

Abstract

BackgroundAppropriate 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.MethodsWe 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.ResultsSeven 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.ConclusionsMajority 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.

Review of drug recalls and quality of pharmaceutical products in Nepal

“…Most of the 759 pharmaceutical products from 37 Nepali pharmaceutical companies inspected in Chitwan in 2017 missed at least one critical information on the label such as drug quantity, name of pharmacopoeia, serial number of pharmaceutical industries, price list, drug classification and information in Nepali language. 10 The reports showed that labels of 84% of drugs did not provide the directions for use. Similarly 90% of drug samples (n=40) in Kathmandu did not comply with the existing regulatory requirement on labelling and 42.5% brands did not indicate the pharmacopoeial standard.…”

“…The DDA in Nepal is equivalent to the US Food and Drug Administration (FDA) and is responsible to prevent the misuse or abuse of drugs and allied pharmaceutical substances 8. Few studies in the past have indicated the circulation of substandard, counterfeit and unregistered drugs in the Nepali market 9–11. DDA Nepal recalls marketed drugs if the drugs do not fulfil any requirement as indicated in the Drug Act 2035 B.S 8.…”

Incidences of poor-quality pharmaceutical products in Nepal

“…Providing required information on the label is another issue. Majority of the pharmaceutical products inspected in Chitwan in 2017 involving 759 drugs from 37 Nepali pharmaceutical companies did not meet the regulatory standards of primary labeling 8 . Most of them missed at least one critical information on the label such as drug quantity, name of pharmacopoeia, serial number of pharmaceutical industries, price list, drug classification, and information in Nepali language.…”

“…The DDA also aims to prevent the misuse or abuse of drugs and allied pharmaceutical substances, the false or misleading information relating to the efficacy and use of drugs and, to control the production, sale, distribution, export, import, storage and consumption of those drugs which are not safe, efficacious, and of standard quality 6 . Few studies in past have indicated the circulation of substandard, counterfeit, and unregistered drugs in the Nepali market 7,8,9 . The DDA Nepal recalls marketed drugs if the drugs do not fulfill any requirement as indicated in the drug act 2035 B.S.…”

Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement

“…The importance of proper labeling of medicines in minimizing medication errors are well known [1]. Falsified, misleading, unclear, insufficient, and ambiguous information given on labels is among the major defects reported to be associated with improper labeling practices [2][3][4][5]. Thus, enhancement of the consistency and the quality of medicine labels are sought through the regulatory frameworks.…”