Ijipsrmnr 79

RESEARCH ARTI CLE Levin Thomas et.
al / I J I PSR / 2 (5), 2014, 1034-1041

Department of Pharmacy Practice I SSN (online) 2347-2154
Available online: www.ijipsr.com April Issue 1034

ASSESSMENT OF OTC DRUG LABELS FOR PATIENT
INFORMATION IN COMMUNITY PHARMACIES IN
THIRUVANANTHAPURAM CITY
1
Levin Thomas*,
2
Jayakrishnan S.S,
3
Sheron Joseph,
4
Neethu Varghese,
5
Dileep C,
6
Arun Rasheed

1,3,4,5,6
Al Shifa College of Pharmacy, Poonthavanam P.O, Kizhattur, Perinthalmanna,
Malappuram, Kerala, I NDI A
2
College of Pharmaceutical Sciences, Govt. Medical College, Thiruvananthapuram, Kerala,
I NDI A

Corresponding Author:
Levin Thomas
Department of Pharmacy Practice
Al Shifa College of Pharmacy, Kerala, I NDI A
Email: levinpharma@gmail.com
Contact Number: +919526850953
International Journal of Innovative
Pharmaceutical Sciences and Research
www.ijipsr.com
Abstract
Over the counter drugs, usually referred as OTC, is defined as a Medication which is safe and effective for use by the
general public without seeking treatment by a healthcare professional.

In most countries of the world, there exists a
category of OTC drugs. OTC drugs have no legal recognition in India, hence all the drugs not included in the list of
prescription-only drugs are considered to be OTC drugs. A cross sectional study was carried on a total of 1290 OTC
drugs selected from 10 community pharmacies located within the vicinity of Thiruvananthapuram Medical College to
evaluate whether OTC drug primary labels have adequate information for patients to make proper self medication
choices. The study period was 3 months. The primary labels of these OTC drugs were then carefully assessed based on
the Drug Facts label guidelines provided by the US FDA for OTC drug labeling. The study revealed that the required
information provided on OTC drug labels in India is usually quite insufficient for the patient for ensuring safe, effective,
and rational use of OTC drugs. There is a clear need for a specific OTC category of drugs in India, with clear-cut laid
down guidelines for their complete labeling to ensure that the patient gets sufficient drug information, so as to make a
responsible decision for self-medication. The regulatory authority should immensely implement proper labelling
standards for the OTC drugs in India for ensuring their safe, effective and rational use.

Key words: OTC, FDA, CDSCO, DCGI
RESEARCH ARTI CLE Levin Thomas et.al / I J I PSR / 2 (5), 2014, 1034-1041

INTRODUCTION
Over the counter drugs, usually referred as OTC (an acronym) is defined as a Medication which
is safe and effective for use by the general public without seeking treatment by a healthcare
professional. [1] These medications do not require a prescription. In countries like U.S, they are
usually stocked in the counter cabinets in the pharmacies, general stores and even in gas stations.
[2] India currently ranks 11th in the global OTC market. In India the drug manufacture, import
and sales are governed by the Drugs and Cosmetics Act (DCA) 1940, the Drugs and Cosmetics
Rules (DCR) 1945 and is implemented by the Central Drug Standard Control Organization
(CDSCO) which is headed by Drug Control General of India (DCGI) who in turn functions
under Directorate General of Health Services. Prescription-only drugs are those drugs that are
listed in Schedules H and X of the Drug and Cosmetics Rules. Drugs listed in Schedule G
(mostly antihistamines) do not need a prescription for purchase but the DCA emphasizes a
mandatory warning label Caution: It is dangerous to take this prescription except under medical
supervision. The drugs listed in the Schedule K which are usually treated as House Hold
products can be sold by a non-pharmacist in remote villages whose population is less than 1000
subjects to other conditions. The drugs are categorized into schedules as per the rules published
in the official gazette vide notification No. F. 28-10/45-(H)1 dated 21/12/1945. The phrase
OTC has no legal recognition in India. The drugs that are not included in the Prescription
only list are considered as OTC. Hence all the OTCs do not require a prescription for
purchase. [3], [4], [5]. The OTC committee of the Organization of Pharmaceutical Procedures of
India (OPPI) is currently working towards the promotion of responsible self medication in order
to promote the OTC market. It is also aiming on promoting the importance of responsible self
medication through awareness programs and community education. The committee not only
promotes OTC use but also emphases on safety [6]. OTC drugs are an important component in
health care, allowing the freedom to the patient to self-medicate for treating minor, common
health problems, at lower costs and without having to spend time and costs of visiting a doctor.
Although OTC drugs are supposed to be relatively safe, readily available and consumed by the
patients without a physicians consent, it is very important that the patient have access to
sufficient information to make an informed choice for the proper use of these drugs. Hence the
label of OTC drugs plays an important role in conveying valuable information to the patient [7].
In USA, the FDA has laid down clear cut guidelines for the labelling of OTC drugs sold in the

country. US FDA Drug Facts standard labelling format for the OTC drugs includes various
components such as active ingredients along with their strength, therapeutic category, indication
of the drug, side effects of the drug, warnings, contraindications, precautions, directions, inactive
ingredients and storage [8]. But there are no such labelling guidelines for the OTC drugs sold in
India. A study was therefore undertaken to evaluate whether the primary labels of OTC drugs
have adequate information as per the US FDA labelling guidelines, for the patients to make
proper self medication choices and ensure rational use of OTC drugs.

METHODOLOGY:
A cross sectional study on assessment of patient information of OTC drug labels was conducted
on a total of 1290 OTC drugs, covering all the categories of dosage forms. The OTC drugs were
selected from 10 community pharmacies located within the vicinity of Thiruvananthapuram
Medical College. The study period was 3 months. The primary labels of these OTC drugs were
then carefully assessed based on the Drug Facts label guidelines provided by the US FDA for
OTC drug labelling.

RESULTS AND DISCUSSION:

The results of the various labelling components that were assessed for the OTC drugs in the
community pharmacy, as per the US FDA guidelines were:
1. Active ingredient(s) along with its strength:

Fig. 1: Active ingredient(s) along with its strength
The presence of the active ingredient in the label is of prime importance as it informs the patient
about the correct drug and the quantity to be taken. 88.75% of the OTC drug labels mentioned
the active ingredient(s) along with their strength, whereas 11.25% did not mention the active
ingredients in them.

2. Therapeutic Category:

Fig. 2: Therapeutic Category
Only 40% of the OTC drug labels mentioned about the therapeutic category of the drug, whereas
60% did not mention the therapeutic category of the drug.
3. Use/Indication of the drug:

Fig. 3: Use/Indication of the drug
Only 52% of the OTC drug labels mentioned about the Use/Indication of the drug, whereas 48%
did not mention the therapeutic category of the drug.
The presence of therapeutic category of the drug and indication/use in the OTC drug label
ensures that the patient is consuming the right drug for his medical condition.
4. Side effects of the drug:

Fig. 4: Side effects of the drug

The presence of side effect information in the OTC drug label helps to inform the patient about
the expected adverse events associated with the drugs and the necessary precautions they can
take to avoid and or minimize them. Only 5% of the OTC drug labels mentioned about the side
effects of the drug, whereas as much as 95% did not mention the side effects of the drug.
5. Warnings related to drug interactions, Contraindications, over dosages & precautions:

Fig. 5: General Warnings about the drug
An OTC drug labels should have warnings regarding the most common drug interactions,
contraindications of the drug, problems associated with the over dosage and the general
precautions to be taken while taking the product. Only 26.25% of the OTC drug labels
mentioned about warnings of the drug, whereas as much as 73.75% did not mention the
therapeutic category of the drug.
6. Warnings related to pregnancy & breast-feeding:

Fig. 6: Warnings related to pregnancy & breast-feeding
Some of the OTC drugs may have teratogenicity or may be even harmful to infants who are
breast feeding. This necessitates the importance of OTC drug labels to compulsorily have
warnings related to pregnancy and breast feeding. 98.75% of the OTC drug labels did not
mention about warnings related to pregnancy and breast-feeding of the drug


7. Keep out of reach of children:

Fig. 7: Instructions to keep out of reach of children
Childrens have a tendency to gulp on various products kept in their homes. This condition
warrants the need to inform the adults to keep the drugs protected in a place that is away from
the reach of the children. Only 37.5% of the OTC drug labels mentioned about warnings to keep
out of reach of children.
8. Directions including how much to be taken, dosage interval, maximum dose allowed per
day and the dose for children.

Fig. 8: Direction for proper intake of the drug
Only 55% of the OTC drug labels mentioned about proper directions to take the drug, whereas as
much as 45% did not contain the direction to take the drug properly. The lack of proper
directions in the OTC drug labels can result in intake of either sub therapeutic amount of the
drug or toxic doses that can be life threatening.
9. Inactive ingredients in the product:

Fig. 9: Inactive ingredients in the product
Present in the
label
Absent in the label
Present in the
label
Absent in the label
Present in the
label
Absent in the label

Only 6% of the OTC drug labels mentioned about the products inactive ingredient. Many
inactive ingredients in the drug such as lactose may cause severe allergic reactions to the patient.
10. Storage conditions:

Fig. 10: Storage conditions
87.5% of the OTC drug labels mentioned about the drugs storage conditions, whereas as much as
12.5% did not mention the storage conditions of the drug. This can result in improper storage of
the drug leading to deterioration in the product quality.
CONCLUSION
The study revealed that the required information provided on OTC drug labels in India is usually
quite insufficient for the patient for ensuring safe, effective, and rational use of OTC drugs.
There is a clear need for a specific OTC category of drugs in India, with clear-cut laid down
guidelines for their complete labeling to ensure that the patient gets sufficient drug information,
so as to make a responsible decision for self-medication. The regulatory authority should
immensely implement proper labeling standards for the OTC drugs in India for ensuring their
safe, effective and rational use.
ACKNOWLEDGEMENTS
The authors are thankful to all the pharmacists of the community pharmacies for rendering the
necessary requirements in this work.
REFERENCES:
1. US Food and Drug Administration. Drug Application for Over the Counter Drugs
[Online]. 2012 [Updated 2012 September 9]. Available from: htpp://Fda.gov/drugs.
Present in the
label
Absent in the label

2. Paruchuri A, Pavithran V, Pavani M, Selvamuthukumaran S, Mohanta GP. Drug
Regulatory Status Assignment Criteria: A contrast among 2 countries. Int J Pharm Sci
Res. 2013; 4(1):181-183.
3. Sarda Rohit, Ladkat Nilesh B, Khodade Ravikiran B, Chaudhari Pallavi M, Kasture
Pramod V. The Indian Pharmaceutical Industry: Evolution of Regulatory System and
Present Scenario. International Research Journal of Pharmacy. 2012; 3(6).
4. Central Drugs Standard control Organization. New Drugs Division
[Online].2012.Available from: cdsco.nic.in.
5. Ministry of Health and Family Welfare. Drugs and Cosmetic Rules [Online].2012. [Cited
2006 March 16]. Available from: Drugs Control.Org/Schedule-H.
6. Subai C Basak. Drug Access and OTC Drugs. Pharma Biz. 2012; 7(1):3-4.
7. Joshi M.P, Vaidya R.X, DeSousa E, Mangaonkar Sneha. Assessment of Over-the-
Counter Drugs Labels in India for Patient Information. Pharma Times. 2012; 44(6):20-21.
8. US FDA. OTC Drug Fact Label. [Online]. 2009. Available from:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.html.

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RESEARCH ARTI CLE Levin Thomas et.

al / I J I PSR / 2 (5), 2014, 1034-1041

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