OTC DRUGS AGAINST
By- Anwar Munjewar
M.Pharm (QA), Sem- I
Allana College of Pharmacy
Medications include over-the-counter drugs(OTC) as
well as prescription drugs.
People often think drugs that do not require a
doctor‟s prescription cannot be harmful.
Over-the-counter drugs also can create problems if
not used in the right way or sometimes if used at the
same time as prescription medications.
Because over-the-counter drugs are used so
frequently and can have harmful effects, it is
important to know the differences between
prescription and over-the-counter drugs. 2
Require a written order or prescription from a
physician, dentist, or nurse practitioner. This
prescription tells a pharmacist to dispense a
Are prescribed to treat a specific medical problem.
Are usually more powerful than over-the-counter
„OTC drugs‟ means drugs legally allowed to sold
over the counter by pharmacist.
Over-the-counter (OTC) drugs are those available
without a prescription.
Are intended for things patients can treat with self-
Are considered safe if warnings and directions are
Headache, Cold/Cough and acidity are the most common
ailments for which Patient's prefer taking an OTC drug.
0 2 4 6 8
Cold & Cough
No. of Patient's
Interesting Facts of OTC
Over-the-counter drug market in India ranks eleventh in
the global OTC market and is expected to reach the
ninth position within the next five years.
The Indian OTC market is estimated to be worth $19
billion with an annual growth rate of 23%.
An estimated 3 out of 4 people routinely self-medicate
with these drug products.
account for 55
percent of drugs
used by Indians.”
Drugs Used by Indians
“SW ITICHING” Policy
The FDA is attempting to make more drugs available to
the general public by switching some frequently used
and safe prescription drugs to OTC status.
More than 700 OTC products on the market today use
ingredients or dosages, that were available only by
prescription, less than 30 years ago.
OTC Medications Are Safe
But Not Risk-Free
As with all medications, there can be risks with use.
The risks of OTC use include:
Delay in seeking medical advice for a serious
Risk of drug-drug/herbal/dietary supplement
Risk of adverse events.
Potential for dependence, misuse and abuse.
In what way the OTC drugs
can be Harmful.
OTC drugs can change the effect of prescription
OTC drugs can mask symptoms of disease.
OTC drugs can lead to overdose.
If misused even common over-the-counter
drugs, such as aspirin, vitamins, or cold remedies
can be harmful.
Misuse & Abuse
• Recent Survey have reported that :
i. In one survey it has been found that only 16% reads
the entire product label.
ii. If they read them they do not follow the directions on
iii. Abuse is most common in adolescents aged 10-17
iv. Adolescents are 18% times more likely to dies from
an OTC overdose than from a illicit drug dose
About Prescription drugs
• According to the Durham-Humphrey Amendment of
1951, drugs are controlled with prescription if they
Not safe for self-medication.
Intended to treat ailments that require the
supervisions of a health professional.
New and without an established safe track record.
Overall we can conclude from different case studies
both OTC as well as Prescription drugs have equal
importance, both having advantages and at the same
time disadvantages also. Though safety margin of
prescribed drugs is more , OTC drugs can not be
labelled unsafe due to there large occupancy in the
market & most of the revenue is generated through
OTC Drugs as comparative to prescribed drugs but
prescribed drugs are under physician supervision
hence there are low chances of toxicities . OTC drugs
does not provide that much of safety.
Hence, we can not take either of the side.
• Senior Series Volume 2, The Center on Rural
Elderly, University of Missouri System ,
Revised by Dr. Bella Mehta, Pharm D (August
• Pharma Knowledge Base, Empowering Knowledge
of pharma proffesionals -2011(Knowledge Process
OTC_Switch-Market_Analysis (2010 -11)