Journal of College of Medical Sciences-Nepal, Vol-20, No.
2, Apr-Jun 2024
Original Research Article ISSN: 2091-0657 (Print); 2091-0673 (Online) Open Access
DOI: 10.3126/jcmsn.v20i2.59866
Status of Primary Labeling of Medicines Manufactured by Nepalese
Pharmaceutical Industries
Binaya Shrestha,1 Anjan Palikhey,2 Kamal Kandel2
Department of Pharmacology, Kathmandu Medical College, Kathmandu, Nepal, 2Department of Pharmacology, Universal
1
College of Medical Sciences, Bhairahawa, Nepal.
ABSTRACT
Background
Proper medication labeling is essential to meet regulatory requirements and guarantee the safety of patients
using the medication. This study aimed to observe the status of primary labeling of medicines manufactured
and marketed by Nepalese pharmaceutical industries.
Methods
A prospective study was conducted between June 2022 to October 2022 in Kathmandu Medical College. Total
of 372 primary labeling of medicines manufactured by Nepalese pharmaceutical companies were assessed as
required by Drug Standard Regulation, 2043 (1986 AD) of Nepal.
Results
This study assessed the primary labeling of 372 medications produced by 46 pharmaceutical companies in
Nepal. Most of the primary labeling had stated manufacturing company's name, address, and country, the
production serial number for the drug, and recommended storage methods. But only 22(5.9%) of them specified
the sub-category and appropriate drug classification was found on 352(94.6%) primary label.
Conclusions
The current study revealed that the status of the primary labeling is satisfactory as majority of the label contained
the essential criteria required by Drug Standard Regulation, 2043 (1986 AD) of Nepal.
Keywords: drug packing; medical labeling; pharmaceutical industries.
INTRODUCTION But there have been cases where different companies
The labeling of medicine is a legal requirement categorize the same generic medication differently,
designed to provide patients with crucial information,1 although limited data is available on this issue in
including brand names, medication type, strength, existing literature.7-8 Therefore, our research aims to
quantity, recommended use, instructions, indications, observe the status of primary labeling of medications
contraindications, and potential side effects, all vital produced and marketed by Nepalese pharmaceutical
for patient safety.2 Ensuring accurate medication companies
labeling is of utmost importance for patient well-being. METHODS
However, in Nepal, there are identified deficiencies A prospective study was conducted between June2022
in recognizing and reporting these requirements. to October2022 in Kathmandu Medical College.
Therefore, it is crucial for the Department of Drug Ethical approval was taken from the Institutional
Administration (DDA), the national regulatory Review Committee (Ref: 2905202209). Those
authority for medicines, to enhance its oversight.3-5 medicines that were manufactured and marketed
In Nepal, allopathic drugs are categorized into three by Nepalese pharmaceutical companies available at
categories, as category Ka(a), Kha(b) and Ga(c).6 pharmacy of Kathmandu medical college, a tertiary
Correspondence: Dr. Binaya Shrestha, Department of Pharmacology, Kathmandu Medical College, Kathmandu,
Nepal. Email address: binaya110@yahoo.co.uk, Phone:+977-9841471602. Article received: 2023-09-09.
Article accepted: 2024-06-30.
158 JCMS | Vol-20 | No.2 | Apr-Jun 2024
Shrestha et al. Status of Primary Labeling of Medicines Manufactured by..
hospital located in Kathmandu, Nepal, was assessed. Primary labeling of all the pharmaceutical
The sample size was calculated by using the formula products had mentioned the brand name and active
n= Z2 p(1-p)/e2 where n=minimal sample size, Z=1.96, ingredients. However drug quantity was present in
e= 0.05. Taking p (prevalence) as 40%, the sample 371(99.7%) and price has been mentioned in 366
size required for this study was 369. A total of 372 (98.4%) (Table 1).
primary labeling of medicines manufactured by Table 1. Availability of general information in the
Nepalese pharmaceutical companies were included in primary labeling. (n=372)
the study. The status of primary labeling of medicines Criteria to be displayed in
Frequency (%)
primary label
was assessed as required by Drug Standard Regulation,
Brand Name 372 (100)
2043 (1986 AD) of Nepal. The regulation states that
Drug Quantity 371 (99.7)
the marketed medicines for human use should contain Active ingredients 372 (100)
16-points information in primary labeling that includes Price 366 (98.4)
Drug name and quantity; Category and sub category The findings also indicated that 20 (5.4%) primary
of the drug; System of medicine; Name of active labels did not include pharmacopoeial information,
ingredient, quantity and the pharmacopoeia; Name of while nearly all of the primary labeling provided
the drug production company, address and the country; details such as the drug manufacturing company's
Serial number for the establishment of drug industry; name, address, and country, the production serial
Serial number for the production of the drug; Batch number for the drug, and recommended storage
number; Date of production; Date of expiry; Price; methods (Table 2).
Storing methods (techniques) and management of Table 2. Availability of pharmaceutical information in
the drug; Caution in Group “a” and “b” (may not be the primary labeling. (n=372)
sold without the prescription of a registered medical Criteria to be displayed in primary
Frequency (%)
label
practitioner); Quantity; Method of use; and additional
Drug production company, address and
information on External preparation (only for external 372 (100)
country
use). A checklist was created to evaluate the fore- Serial number for production 372 (100)
mentioned requirements of primary labeling of various Batch number 370 (99.5)
Date of production 368 (98.9)
types of dosage forms. Further analysis was done by Date of expiry 366 (98.4)
entering the collected data in MS excel. Storage 372 (100)
Pharmacopoeia 352 (94.6)
RESULTS
This study assessed the primary labeling of 372 Only 48 instances (12.9%) of the primary labels
medications produced by 46 pharmaceutical contained information regarding on direction of use
companies in Nepal. The various dosage forms and 5.6% had stated system of medicine. Moreover,
evaluated are illustrated in (Figure 1). it is worth noting that around one percent (1%) of
the products were discovered to present deceptive
information regarding caution. For instance, they
falsely indicated that OTC drugs (Group "c") should
not be sold without the prescription of a registered
medical practitioner. None of the products mentioned
serial number for establishment of pharmaceutical
industry (Table 3).
Nearly all of the primary labels stated the drug's
category, but only 22(5.9%) of them specified the
sub-category. The appropriate drug classification was
Figure 1.Various dosage forms that are evaluated. found on 352(94.6%) primary label (Table 4).
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Shrestha et al. Status of Primary Labeling of Medicines Manufactured by..
Table 3. Availability of information related to clinical use of in Sri Lanka by Jayasinghe et al., where all labels
the medicine in the primary labeling. (n=372) similarly featured the aforementioned criteria.12
Criteria to be displayed in primary label Frequency (%) During this study we also noted that three primary
System of Medicine 21(5.6) labels (1%) contained cautions related to group
Quantity to be used 368 (98.9)
'C' medications, potentially leading to confusion.
Caution in group a and b (not to be sold without
259 (69.6) This finding is different to the study conducted in
the prescription of a register medical practitioner)
Misleading informations 3 (0.8) Chitwan district, Nepal where seven percent of the
External preparation (only for external use)(n=40) 39 (97.5) label contained cautions in group C medications.1
Method of Use 48 (12.9) The majority of the products observed in this
Table 4. Assessment of information related to drug study lacked usage instructions, which are crucial
category in the primary labeling. (n=372) for preventing medication errors, particularly
Criteria to be displayed in primary label Frequency (%) with modified-release products. For example,
Category of drug it is essential to include labels such as "swallow
Legible 371(99.7) the tablet whole without breaking or crushing"
Illegible 1 (0.3)
for controlled-release tablets and "chew the
Sub-category of drug 22 (5.9)
tablets before swallowing" for chewable tablets
Appropriateness of drug category
to ensure that patients use them as intended. Drug
Appropriate 352(94.6)
Inappropriate 19(5.1) Standard Regulation, 2043 (1986 AD) mentions
Illegible 1(0.3) that the label of the medicines should contain
pharmacopoeial information which essentially
DISCUSSION reflects standard of the product was missing in
The pharmaceutical industry in Nepal is on a some (6%) of the labels. Perhaps, this issue should
continuous growth trajectory, boasting more than be of serious concern for stakeholders because
15,000 registered products, over 300 registered this is considered important for drug safety and is
manufacturing facilities, and over 16,000 pharmacy of special concern for consumers. In the current
outlets. This expansion places a heightened demand study majority of products had not mentioned sub-
on the regulatory authority (DDA) to enhance their category of drugs on their labeling. Similarly, most
oversight and streamline their operations.9As a of the products were found to lack information
result, there has been a recognized gap between on system of medicine they belong to. Practice of
regulatory provisions and actual practices, as categorizing drugs as Ka(a), Kha(b) or Ga(c) was
highlighted in previous studies.3-5 To address observed in almost all the label. This finding is similar
this issue, it is imperative to regularly assess the to the study conducted in Chitwan district, Nepal.1
primary labeling of medications. Numerous studies The study showed lack of essential criteria in some
have underscored the pivotal role of labeling and of the labeling. Studies in SriLanka3and Malaysia, 4
packaging in medication errors.2, 10 consequently, have also reported insufficient labeling of dispensed
ensuring proper labeling of marketed medicines medicines as required by the regulatory authorities.
is crucial for adhering to regulatory requirements This study represents the inaugural endeavor in
and safeguarding patient medication safety.11 In the Nepal to evaluate the situation of insufficient
present research, almost all of the primary labels primary labeling and offers recommendations to
included information such as the name of the stakeholders for its improvement.
pharmaceutical company, its address and country CONCLUSIONS
of origin, the production serial number for the The current study revealed that the status of the
medication, and recommended storage guidelines. primary labeling is satisfactory as majority of the
This aligns with the findings of a study conducted label contained the essential criteria required by Drug
160 JCMS | Vol-20 | No.2 | Apr-Jun 2024
Shrestha et al. Status of Primary Labeling of Medicines Manufactured by..
Standard Regulation, 2043 (1986 AD) of Nepal. The Nepalese pharmaceutical products.
current study also tried to emphasize regulatory body Conflict of interest: None
should be stricter in monitoring primary labeling of Funding: None
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Citation: Shrestha B, Palikhey A, Kandel K. Status of Primary Labeling of Medicines Manufactured by Nepalese
Pharmaceutical Industries. JCMS Nepal. 2024; 20(2): 158-61.
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