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Medilaw

What are the Legal Aspects of Over-the-counter


Sale of Allopathic Medicines?
MC Gupta

The term over-the-counter drugs (OTC drugs) is


a loose and legally undefined term. It does not find
a mention in the Drugs and Cosmetics Act, 1940,
or the Drugs and Cosmetics Rules, 1945. Before
discussing the legal aspects of OTC drugs, this
term needs to be defined.

New products that conform to a final monograph may be


marketed without further FDA review. Those that do not
conform must be reviewed by the New Drug Application
process. A drug company may also petition to change a
final monograph to include additional ingredients or to
modify labeling.

The United States Department of Food and Drug


Administration (FDA) defines OTC drugs as
drugs that are safe and effective for use by the
general public without seeking treatment by a
health professional. The role of FDA in regulation
of OTC drugs is as follows:

http://www.fda.gov/drugs/developmentapproval
process/howdrugsaredevelopedandapproved/
approvalapplications/over-the-counterdrugs/default.htm

The scope/examples of OTC drugs are described


by the FDA as follows:

Over-the-counter (OTC) medicines are drugs you can


buy without a prescription. Some OTC medicines relieve
aches, pains and itches. Some prevent or cure diseases,
like tooth decay and athletes foot. Others help manage
recurring problems, like migraines.

In the United States, the Food and Drug Administration


decides whether a medicine is safe enough to sell overthe-counter. Taking OTC medicines still has risks. Some
interact with other medicines, supplements, foods or
drinks. Others cause problems for people with certain
medical conditions. If youre pregnant, talk to your
healthcare provider before taking any medicines.

It is important to take medicines correctly, and be


careful when giving them to children. More medicine
does not necessarily mean better. You should never
take OTC medicines longer or in higher doses than the
label recommends. If your symptoms dont go away,
its a clear signal that its time to see your healthcare
provider.

h t t p : / / w w w. n l m . n i h . g o v / m e d l i n e p l u s /
overthecountermedicines.html

The Wikipedia has this to say about OTC drugs:

OTC drugs are medicines that may be 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. In many countries, OTC drugs are
selected by a regulatory agency to ensure that they are
ingredients that are safe and effective when used without
a physicians care. OTC drugs are usually regulated

Drug Applications for OTC Drugs

Over-the-counter (nonprescription) drug products


play an increasingly vital role in Americas healthcare
system. OTC drugs are defined as drugs that are safe
and effective for use by the general public without
seeking treatment by a health professional. FDAs
review of OTC drugs is primarily handled by CDERs
Office of Drug Evaluation IV. The Nonprescription
Drug Advisory Committee meets regularly to assist the
agency in evaluating issues surrounding these products.
This committee has played a major role in the growth of
prescription to OTC switches in recent years.

Because there are over 3,00,000 marketed OTC drug


products, FDA reviews the active ingredients and the
labeling of over 80 therapeutic classes of drugs, for
example analgesics or antacids, instead of individual drug
products. For each category, an OTC drug monograph
is developed and published in the Federal Register. OTC
drug monographs are a kind of recipe book covering
acceptable ingredients, doses, formulations and labeling.
Many of these monographs are found in section 300 of
the Code of Federal Regulations.
Once a final monograph is implemented, companies can
make and market an OTC product without the need for
FDA pre-approval. These monographs define the safety,
effectiveness and labeling of all marketing OTC active
ingredients.

Advocate and Medicolegal Consultant, New Delhi

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by active pharmaceutical ingredients (APIs), not final
products. By regulating APIs instead of specific drug
formulations, governments allow manufacturers freedom
to formulate ingredients, or combinations of ingredients,
into proprietary mixtures.

The term over-the-counter may be somewhat


counterintuitive, since, in many countries, these drugs
are often located on the shelves of stores like any other
packaged product. In contrast, prescription drugs are
almost always passed over a counter from the pharmacist
to the customer. Some drugs may be legally classified
as over-the-counter (i.e., no prescription is required),
but may only be dispensed by a pharmacist after an
assessment of the patients needs and/or the provision
of patient education. In many countries, a number of
OTC drugs are available in establishments without a
pharmacy, such as general stores, supermarkets, gas
stations, etc. Regulations detailing the establishments
where drugs may be sold, who is authorized to dispense
them, and whether a prescription is required vary
considerably from country to country.

Those permitted to sell drugs under a


licence can sell two types of drugs, namely,
Prescription Drugs and Non Prescription
Drugs. The Prescription Drugs are those
drugs, which are listed in Schedule H, which
is titled as Prescription Drugs. In accordance
with Rule 65(9), such drugs can be sold only
on the basis of a prescription issued by a
Registered Medical Practitioner as defined
in Rule 2(ee) of the D&C Rules, 1945.
In view of the Supreme Courts judgment
in Mukhtiar Singh case, the definition of a
Registered Medical Practitioner as defined
in Rule 2(ee) of the D&C Rules, 1945, now
means, for practical purposes, a person
having a degree in modern medicine.
In terms of Rule 123, drugs listed in Schedule
K of the D&C Rules, 1945, do not need a
licence for sale if sold by shop other than a
chemists shop. Drugs in Schedule K include
the following:

http://en.wikipedia.org/wiki/Over-the-counter_
drug

zz

Drugs not intended for medicinal use

zz

Quinine and other antimalarial drugs

The crucial question is - To which counter are


we referring when we use the term - over the
counter?

zz

Magnesium sulfate

zz

Substances intended to be used for


destruction of vermin or insects, which
cause disease in human beings or animals
viz. Insecticides and Disinfectants.

zz

Household remedies, namely:

Are we referring to the sales counter of a pan


wallah, grocer or a general store (as is the implied
meaning of this term in USA)?

OR

Are we referring to the sales counter of a chemist/


druggist, pharmacist etc.?

It is obvious that the term OTC refers to those


drugs, which can be bought across the counter at
a grocery or general store etc. which can stock and
sell certain drugs without obtaining any license
required under the D&CA in terms of section
18(c) in chapter 4 of the D&CA, 1940, which states
that - no person shall sell, any drug [except under,
and in accordance with the conditions of, a license
issued for such purpose under this Chapter.

Thus any drug to which chapter 4 of the D&C Act,


1940, applies cannot be sold by a grocer or general
store, etc.

It appears that the scheme of the Indian Drugs and


Cosmetics Act/Rules is as follows:

All drugs except those listed in Schedule K


of the D&C Rules, 1945, need a licence (in
terms of Rule 65), permitting them to be
sold.

Aspirin tablets

Paracetamol tablets

Analgesic balms

Antacid preparations

Gripe water for use of infants

Inhalers, containing drugs for


treatment of cold and nasal congestion

Syrups, lozenges, pills and tablets for


cough.

Liniments for external use

Skin ointments and ointments for


burns

Absorbent cotton wool, bandages,


absorbent gauze and adhesive plaster.

Castor oil, liquid Paraffin and Epsom


salt.

Indian Journal of Clinical Practice, Vol. 23, No. 12, May 2013

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Eucalyptus oil

Tincture iodine, Tincture Benzoin


Co. and Mercurochrome solution in
containers not exceeding 100 ml.

zz

first aid

Tablets
of
Iodochlorohydroxy
quinoline - 250 mg.

zz

Contraceptives

zz

Cosmetics

zz

Ophthalmic ointments of the tetracycline


group of drugs

zz

Hair fixers

zz

Radio pharmaceuticals

zz

Tablets of chloroquine salts

zz

Preparations applied to human body


for the purpose repelling insects like
mosquitoes

Medicated dressings and bandages for

zz

Oral rehydration salts

zz

White or yellow petroleum jelly IP


(nonperfumed)

zz

Morphine tablets

zz

First Aid Kit supplied along with motor


vehicle

by

the

manufacturer

or

its

distributor at the time of first sale of


vehicle
zz

Nicotine gum containing upto 2 mg of


nicotine.

In view of the above, it is clear that the term


OTC drugs would mean, in the context of Indian
laws, drugs in Schedule K. The main drugs in
Schedule K have been listed above.

Q. What is the Medicolegal Responsibility of the Hospital Management when a Medicolegal


Patient from a Foreign Country Dies? What should be Done if the Relatives do not Take Away the
Body? What are the Requirements for Embalming of the Body?
Ans.

If it is a medicolegal case, it is obvious that the police would already be in the picture. If such a patient,
whether an Indian or foreigner, dies, it is for the police to take further action. The role of the hospital would
be to shift the body to the mortuary till the police takes action. It is not the headache of the hospital to worry
about how to dispose of the body if relatives do not come forward to claim it.

Hospital forensic medicine department and the hospital advocate should be kept involved. They might, in
specific circumstances, advise the hospital administrator to inform the concerned government authorities
(Health Directorate; Ministry). The hospital has no responsibility for embalming the body unless requested
to do against payment.

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Indian Journal of Clinical Practice, Vol. 23, No. 12, May 2013