This document discusses over-the-counter (OTC) drugs, including their definition, classification, use, and regulation. It notes that OTC drugs are medicines that can be purchased without a prescription because they are considered safe and effective for self-treatment of minor ailments when used as directed. The document outlines the three phase review process by which the FDA approves OTC drug ingredients and publishes drug monographs establishing conditions for general recognition of their safety and effectiveness. It emphasizes the importance of educating consumers about the rational, responsible, and risk-aware use of OTC medications to promote safe self-treatment without medical supervision.

1. RATIONAL USE OF OTC {OVER THE
COUNTER) DRUGS & ITS SALES
By:- Dr. Manish Pal Singh,
Associate Professor
1Agra Public Pharmacy College, Agra
Source*- https%3A%2F%2Fbusiness.medicaldialogues.in

2. What is OTC-Drugs?
According to FDA-
“OTC drug is safe when it has low incidence of ADR’s & Side effects
under conditions of widespread availability”
➢ It’s a Non-prescription medicines.
➢ In broader sense all non-prescriptional medicines including traditional
herbal medicines or nutritional supplements (pharmaceutical care
meaning).
➢ An Simply say to OTC-
“An OTC drug product is a Product marketed for use by the
consumer without the intervention of a health care professional.”
Agra Public Pharmacy College, Agra 2

3. Differences Between Prescription & Non-
prescription Drugs
Agra Public Pharmacy College, Agra 3
• That can only be obtained with a
prescription from an appropriate
health care practitioner.
Prescription
Drugs
• Self Prescribed- we decided what
we need.
Non-prescription
(OTC)-Drugs
But Both are reviewed by healthcare
person & can be interact with each
other

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Criteria's of OTC-
Low toxicity
No increase
resistance
First approved as
prescription
Later on Approved
As OTC

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OTC-Drugs Can be Classified as-
Category-I
• Generally recognized as safe and effective for the
claimed therapeutic indication
Category-II
• Not generally recognized as safe and effective for
claimed indications
Category-III
• Insufficient data available to permit final classification

6. Significance of OTC Counters:-
✓ FDA requires that OTC labels should be more detailed as compared to
prescription drug labels.
Agra Public Pharmacy College, Agra 6Source*- https%3A%2F%2Fwww.poison.org

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OTC Medication Used by- CATEGORY
OTC
Analgesics
Cough Syrups
Allergy and sinus
Vitamin and Mineral
Supplements

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Source*-
https%3A%2F%2Fwww.today.com
https%3A%2F%2Fwww.gartner.com
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Phase’s of OTC Drug Review
• The first phase was accomplished by advisory review
panels.
• In this determine drug ingredients could be generally
recognized as safe and effective for use in self-
treatment.
Ist-Phase
• The second phase of the OTC drug review phase.
• Review of ingredients in each class of drugs, based
on the panel’s findings, on public comment, and on
new data that may have become available.
• The agency, in turn, publishes its conclusions in the
Federal Register in the form of a tentative final
monograph.
• Requests to be submitted for a hearing before the
Commissioner of FDA.
IInd-Phase

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The monographs establish
conditions under which certain
OTC drug products are generally
recognized as safe and effective.
The publication of final
regulations in the form of
drug monographs
IIIrd
Phase
FDA approved these products for general
use.

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OTC Drugs Marketing
NDA process OTC Monographs
•Pre-marketing approval
•Confidential filling
•Drug products are specify
•May require a user fee
•Mandated FDA review timelines
•No pre-marketing approval
•Public process
•Active ingredient –specific
•No user fees
•No mandated time lines

12. ➢ Purchase and use of OTC drugs without full knowledge is not only a waste of
resources for all stakeholders but can be harmful for consumers.
➢ Creating awareness of rational drug use is only possible through continued
public education with a broad vision of good health and wellbeing of the
society.
➢ The availability of over-the counter medications makes it possible for
consumers to treat numerous ailments without the supervision of a health
care professional.
➢ Patient education and counseling are particularly important to promote safe and
effective use of over-the counter products.
➢ Don’t mix Rx and OTCs including herbals.
➢ Give your doctor a list of ALL meds.
Agra Public Pharmacy College, Agra 12

13. Risk/Beneficial Role’s of OTC Drugs
RISK Factors
• Inaccurate diagnosis.
• Delay in obtaining needed
therapy
• Drug resistance
• Failure to follow label
instructions
• Perceived loss of control by
physicians
Benefit Factors
• Increased access
• Decreased frequency of
visits to physicians, leading
to lower healthcare costs.
• Improved education of
consumers.
• Decreased cost to third
party payers
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OTC Medication Use----- “GENRALLY USE 3-R”
OTC
R- Risk
R- Respect
R- Responsibility

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Source*- https%3A%2F%2Fwww.slideshare.net%2Fmshubhankar%2Fotc-drug-market-future-growth-driver-for-ipm-