This document discusses over-the-counter (OTC) drugs and regulations regarding OTC drugs in India, the United States, and Europe. It defines OTC drugs as drugs that can be purchased without a prescription and are considered safe for self-treatment. The key points covered include: OTC drug schedules in India, examples of common OTC drugs, regulations governing labeling, advertising and distribution of OTC drugs in each region, and processes for switching a drug from prescription to OTC status. Comparisons are made between the regulatory approaches in different jurisdictions.

1. PRESENTED BY
ROSHNI RATHORE

2. DEFINITION
OTC Drugs are drugs that have been found to be safe and
appropriate for use without the supervision of a health care
professional such as a physician, and they can be purchased by
consumers without a prescription.
 Self treat
 Self-diagnose
 Self manage
 Advertised.

3. At present, there is no OTC schedule in the Drugs and
Cosmetics Rules 1945.
Hence, any drug outside schedule H, G and X is considered to
be an OTC drug.
1. SCHEDULE K
Household remedies
Item No.13
Form 20 A
Form 20B

4. Examples
 Aspirin tablets, Antacid preparation, Analgesic balm etc.
 Cold and nasal congestion preparations &
syrups, lozenges, pills and tablets for cough.
 Digene (antacid)
 Paracetamol

5. 2. Exemption of Schedules G, H or X
 Topical or external use (except ophthalmic and ear / nose
preparations containing antibiotics and / or steroids)
applications of the ingredients from these schedule.
 Clause – 2 : The salts, esters, derivatives and preparations
containing the above substances excluding those intended for
topical or external use.

6. Examples
 Diclofenac (Volini Gel).
 Clotrimazole.
 Oxymetazoline.
 Chericof and Honitus
(Chlorpheniramine).

7. 3. AYURVEDIC OTC DRUGS
The Ayurvedic State Licensing Authorities.
Examples
 Vicks VapoRub,
 Amrutanjan Pain Balm,
 Zandu Pain Balm,
 Iodex Pain Balm,
 Moov Pain Cream,
 Itch Guard Cream,
 Eno Fruit Salt antacid

8. 1. The Drugs and Cosmetics Act, 1940 (DCA) and its
subordinate legislation, the Drugs and Cosmetics Rules, 1945
(DCR).
2. Other regulations are which have a bearing on the
pharmaceutical business in India;
Drug (Prices Control) Order, 1995,
Example; Acetylsalicylic acid And Ephedrine
Drugs (Magic Remedies) Objectionable Advertisement
Act, 1954

9. 1.Rule 96 of the DCR
2. Rule 97
3. Maximum Retail Price (MRP) printed on the label.
The Standards of Weights & Measures Act
(Packaged Commodities)
4.Warnings
5. Symbols (Rx, X )
6. Rule 161

10. Non Prescription(OTC) Registration
Single or combination containing non-prescription drugs, i.e. out
of Schedule G,H or X cannot be directly granted as OTC.
First it will be approved as Rx (prescription) and later on
application is required to be filed for switch from Rx to OTC.

11. In the United States the manufacturing & sale OTC drug product
is regulated by, USFDA
OTC Drug Product Allowed to be marketed either:
(1) Pursuant to an FDA OTC monograph; or
(2) Pursuant to an NDA for products that do not fit within a
specific monograph

12. Types of NDAs
1. Rx to OTC switches
 Full switch (NDA supplement).
 Partial switch (new NDA).
2. Direct to OTC
 NDA deviation ( NDA deviation (330.11))
 Generic (ANDA)

13.  Division of Non-prescription regulation
Development(DNRD) in ODE IV.
 “Recipe book” for marketing an OTC drug
 „ „ A list and explanation of GRASE conditions
GRASE = Generally Recognized As Safe and Effective
 „ „ Final monographs are published in Code of Federal
Regulations: 21 CFR parts 331-358

14. §331.10 Active
ingredients…Calcium, as carbonate
or phosphate; maximum daily
dosage limit 160mEq. calcium
(e.g., 8 grams calcium carbonate
331.30(b) Indications…‘‘For the
relief of’’ (optional, any or all of
the following:) ‘‘heartburn,’’ ‘‘sour
stomach, 'and/or ‘‘acid
indigestion’’
331.30(c) Warnings…“Do not take
more than (max. rec. daily dosage)
in a 24-hour period, or use the
maximum dosage of this product
for more than 2 weeks

15. Restricted OTC Substances
Examples;
1. Methamphetamine
 The Methamphetamine Precursor Control Act
 A House Bill 512 passed in the State Senate on
February 2,2010
2. Preventing Abuse Of cough treatment Act (PACT Act)
 Dextromethorphan
3. Emergency Contraceptive

16. 1. 21 CFR 201.66 for labelling requirement of OTC product in
US.
2. Drug Facts
Standardized labelling format Similar to “Nutrition Facts”
& “Supplement Facts”
3. Federal Trade Commission (FTC)
4. National Advertisement Division

17.  Tylenol
 Tetrahydrazoline
 Next choice
 Plan B

18.  The main directives regarding medical products for human use
are as follows:
 2001/83/EC
Articles 70-75 of Directive 2001/83/EC have been reserved
for classification of medical products for human use.
Article 70 stated that when a marketing authorization is
granted, the competent authorities should specify the
classification of the medical product as one subject to medical
prescription, or as one not subject to medical prescription.

19. 1. Article 71 State that; Criteria to be use for classification of
medicinal product, Established With purpose to prioritize
patient safety.
Prescription drugs
 Subjected to be Danger
 Used incorrectly
 Side effect
 Administered parenterally
2. Article 72

20. 1. DIRECT PROMOTION TO CONSUMERS
Article 88 of the Directive 2001/83/EC dated November 6, 2001
2. OTC LABELLING REQUIREMENT
Articles 54-69 of the directive 2001/83/EC are reserved for
the labelling and prospectuses of medical products for human
use.

21.  Article 54,55,59 of Directive 2001/83/EC
 Article 62 of Directive 2001/83/EC
 Title V of the Directive 2001/83/EC
Articles listing the requirements relating to the contents of the
labelling and package.

22. S.N
O
Key point consideration US FDA INDIA EUROPE
1. OTC NDAAPPLICATION Us FDA Drug & cosmetic act
1940 (For
prescription drugs)
2001/83/EC
2. OTC MONOGRAPH The Division of Non-
prescription Regulation
Development (DNRD
NA NA
3. LABELLING
REQUIREMENT 21CFR 201.66
NO Separate
requirement
Articles 54-69 of
the directive
2001/83/EC
4. ADVERTIZMENT Federal Trade Commission
(FTC)
Magic remedies act
1954
Article 88 of the
Directive
2001/83/EC
5. DISTRIBUTION Supermarket Generaly small
independent shop
Supermarket/ even at
fuel station
6. SWITC RX TO OTC Drug review panel Lacks such system Directive
2004/27/EC
7. PRICE CONTROL NA DPCO 1995 89/105/EEC
(TRANPERENCY
DIRECTIVE)

23. UNITED STATE
The manufacturer requests the switch by submitting a
supplemental application to its approved NDA.
• A petition from the manufacturer to the FDA.
• Recommendation from the OTC review panel
EUROPE
Article 74a of Directive 2001/83/EC amended by 2004/27/EC
• significant preclinical trails and clinical trial
• Data exclusivity

24. INGREDIENT ADULT DOSAGE PRODUCT CATEGORY DATE OF OTC
APPROVAL
PRODUCT EXAMPLES
1 Ibuprofen and
phenylephrineHCl
(NDA)
200mg
ibuprofen and
10mg
phenylephrine
HCl
analgesic/decon
gestant
May 27, 2010 Advil
Congestion
Relief (Pfizer)
2 Fexofenadine
hydrochloride (NDA)
30 mg; 60 mg;
180 mg 30 mg/5
Ml
Antihistamine January 24,
2011
Allegra
(Chattem)
3 Fexofenadine
hydrochloride and
pseudoephedrine HCl
(NDA)
180 mg; 240 mg antihistamine/
decongestant
January 24,
2011
Allegra D 12-
Hour (Chattem)
4 Fexofenadine
hydrochloride and
pseudoephedrine HCl
(NDA)
antihistamine/
decongestant
January 24,
2011
Allegra D 24-
Hour (Chattem)
5 Oxybutynin (NDA) 3.9 mg overactive
bladder
January 25,
2013
Oxytrol for
Women (Merck)

25. Regulation requirement
• Reduce drug abuse
• Improve patient safety
Comparatively study
India is one of emerging country require separate criteria for
“OTC REGULATION” for enhance patient safety and reduce
Drug abuse.
ORGANISATION OF PHARMACEUTICAL PRODUCERS
(OPPI) works toward the promotion of OTC in INDIA.

26.  http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf
 http://mohfw.nic.in/
 http://cdsco.nic.in/index.html
 http://www.indiaoppi.com/OPPI%20Code%20of%20Marketin
g%202007.pdf
 http://www.chpa-info.org/scienceregulatory/SR_SPL.aspx
 http://www.asiflex.com/asiotc.pdf
 http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health
_products_regulation/western_medicines/files_1.Par.96320.Fil
e.tmp/ReclasspdtAZ1603212.pdf.