Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription, from a healthcare professional, as compared to prescription drugs , which may be sold only to consumers possessing a valid prescription. OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care.

1. 1
Marketing project report on customer
behaviour towards use of various
Over the counter (OTC) medicines

2. INTRODUCTION
 Over-the-counter (OTC) drugs are medicines sold directly to a
consumer without a prescription, from a healthcare professional, as
compared to prescription drugs , which may be sold only to
consumers possessing a valid prescription.
 OTC drugs are selected by a regulatory agency to ensure that they
are ingredients that are safe and effective when used without
a physician's care.
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3. 3
Two post-1938 regulatory pathways exist for the legal marketing of OTC
products:
1. marketing in compliance with an OTC drug monograph
2. marketing under the authority of an approved product-specific new drug
application (NDA), or an abbreviated new drug application (ANDA)
REGULATORY PATHWAYS IN
MARKETING OF OTC DRUGS

4. 4
AIMS AND OBJECTIVES
The main objective of this study is :
To assess the self – medication practise
 To identify most commonly used OTC drugs
 To assess common types of illness in people

5. 5
LITERATURE REVIEW
 Finley et al 1997., studied Self-administration of Over-the-
counter Medication for pain among adolescent .
 Eric P. Brass 2001 ., studied Changing Status of Drugs from
Prescription to Over-the-Counter Availability.
 Verma Rohit K et. al 2010 ., self medication among
professional students in North India .

6. 6
Sr. No. Various OTC drugs Brand names
1 Analgesics Saridon ,
Disprin
2 Antipyretics Crocin ,
Calpol
3 Cough Preparations Corex , Torex ,
Benadryl ,
D- Cold total
4 Antibiotics Amoxil ,
Trimox
5 Anti- allergics Cetzine ,
Levorid
6 Antacids Zentac ,
Gelusil
VARIOUS OTC DRUGS

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 The Over-the-Counter (OTC) Drug Review was established to
evaluate the safety and effectiveness of OTC drug products marketed
in the United States before May 11, 1972
 It is a three-phase public rulemaking process (each phase requiring
a Federal Register publication) resulting in the establishment of
standards (drug monographs) for an OTC therapeutic drug class.
OTC DRUG REVIEW

8. DEVELOPMENT AND REGULATION OF
OTC (NONPRESCRIPTION) DRUG
PRODUCTS
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 Over-the-counter (OTC) drugs are developed under the OTC
Monograph Process or through the New Drug Application (NDA)
Process.
 FDA's review of OTC drugs is primarily handled by the Center
for Drug Evaluation's Office of Drug Evaluation IV.

9. OTC DRUGS DEVELOPED UNDER
THE OTC DRUG MONOGRAPH
PROCESS
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 Division of Nonprescription Drug Products (DNDP) is also
responsible for the development of the OTC drug monographs.
 Data supporting the safety and efficacy of OTC active ingredients
in a particular drug monograph are reviewed by appropriate scientific
personnel.
 Efficacy data may require the input of a Medical Officer and/or
Statistician from a prescription review division.
 Carcinogenicity or other animal toxicology data may require input
from a CDER pharmacologist. So, while DNDP is considered to be
the lead division in the development of an OTC drug monograph,
reviewers from multiple divisions within the Office of New Drugs
(OND) may be involved in this process.

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 Although pre-approval by FDA for drugs marketed under a drug
monograph is not required, many companies seek assurance that the
product they intend to market under the drug monograph complies
with the regulations.
 These cases are primarily handled by DNDP unless consultation
with the Division of Unapproved Drugs and Labeling Compliance or
another review division is necessary.
 If a drug cannot comply with the drug monograph, an IND and
approved NDA is necessary before the drug product may be
marketed .

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REQUIREMENTS OF OTC DRUG
MONOGRAPH
“Recipe book ” for marketing an OTC
drug „
A list and explanation of GRASE
conditions GRASE = Generally Recognized
As Safe and Effective
 GRASE active ingredients
1. dosage strength
2. dosage form
„ Labeling requirements
1. indications
2. warning & directions for use warning
 „ Final formulation testing

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PLAN OF WORK
1. Data collection on use of OTC drugs through web survey
2. Interaction with people taking medicines without prescription
3. Adverse drug reaction caused due to use of OTC drugs
4. Survey on age groups relying on self- medication
5. Collection of information on most commonly used OTC drugs
nowadays

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ADVANTAGES OF OTC DRUGS
 Convenient
 Economical
 Enable patients to control their own chronic
conditions
 Useful for mild illness
 Reduce the pressure on medical services where
health care personnel are insufficient
 Time saving

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DISADVANTAGES OF OTC DRUGS
 Lack of knowledge about drug dose
 Adverse Drug Reactions
 Chances of using wrong medication
 Drugs interactions

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REFERENCES
1. Christine T. Chambers, Graham J. Reid, Patrick J. McGrath, G.
Allen Finley, Self-administration of Over-the-counter
Medication for pain among adolescents ,Arch Pediatr Adolesc
Med. 1997;151(5):449-55.
2. Eric P. Brass ,Changing the Status of Drugs from Prescription
to Over-the-Counter Availability , N Engl J Med 2001;
345:810-816.

16. Thank you !!!....
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