Usage of Chemotherapeutic Banned Drugs in India

Usage of Banned Drugs in India
AIM OF WORK:-
1
Sale of spurious and banned drugs is rampant

in India. The pharmaceutical companies and
defaulters are playing with the lives of thousands of
people who are not aware of the harmful effects of
the drug they sell.
India has become a hub of banned drug. It is
shocking to find the list of drugs ,which we consume
are actually banned in other countries. These drugs
are selling as hot cakes in India. It is ghastly, but
true.
India has become a dumping ground for
banned drug. The business for production of
banned drug is blooming and because there are
more consumers here and all illegalities are duly
obeyed. Very few people are unaware about the
banned drug and consume them without knowing its
extent of damage in their body. The issue is severe
and we must not delay in spreading the warning
message to the offender and innocent people.
As big time business enterprise and small
time defaulters, pharmaceutical field is growing in
every direction. There are few provisions for a
proper control of spurious drug in Indian markets.
Worst than that is little knowledge and slap dash
2
attitude of the buyers. Even then, a large population

takes medicine and drugs without prescribing a
doctor, which can be very dangerous.
The aim of this project is to present details of
selected banned drugs in India. This project will be
helpful to get elaborate information on mode of
action, side effects, uses and the reason for ban of
the selected drugs under study. (19)
3
Introduction
4
Definition of Banned Drugs :- The drugs those

are prohibited for manufacture and sale through
gazette notification under section 26A of drugs and
cosmetics act, 1940 by the ministry of health and
family welfare.
History :- More than 60,000

branded formulations are
available in India. These
preparations contain either single
drug or drug in fixed dose
combination. All formulations are used for treatment
or prevention of diseases. Out of it only few drugs
are life saving and essential drugs, otherwise
maximum of them are available as alternative or
substitute to each other.
Though the drug is approved by Drugs

Controller General India for manufacturing and
marketing in country only after consideration of all
aspects such as therapeutic effect, side effect, toxic

effect, etc… The physician has to follow rational
5
prescription practice in consideration of drugs

available in markets.
Among the studied prescription the most

common group of
drugs prescribed by
surgeons for the last
ten years were
antibiotics (93%),
analgesic (60%),
antacids (43%) and anthelmintics (10%).
According to our country, after amendment of

drugs act in 1982, government has acquired the
power to prohibit the manufacture and sales of
drugs and fixed dose combination or irrational
drugs. The government issued a first gazette
notification in July 1983, banning several drugs and
their FDC after due consideration.
Till the date the Indian government has banned

several FDCs and imposed restriction on many
6
drugs and their combination with other drugs for its

manufacturing and marketing in India.(7)
7
Chemotherapy :-
8
Chemotherapeutic agents are chemicals that

are intended to be toxic for the pathogenic organism
but innocuous for the host. (1)
OR
These are the agents which are concerned with

the effect of drug upon micro-organisms and
parasites, living and multiplying in a living
organisms. (2)
OR
These are the agents which are capable of

inhibiting or destroying invading microbes, parasites
or cancer cells while having minimal effect on
healthy living tissue. (3)
OR
It is the treatment of systemic infection /

malignancy with specific drugs that have selective
toxicity for the infecting organism / malignant cell

with no / minimal effect on the host cell. (4)
9
CLASSIFICATION OF
CHEMOTHERAPEUTIC AGENTS :-
 Anti-malarial agent
 Anti-fungal agent
 Anti-viral agent
 Anti-Protozoal agent
 Anti-bacterial Anti-Biotics
10
 Anti-Neoplastic agent
 Anthelmintics
 Sulphonamides
 Synthetic Anti-bacterial agent
 Anti-leprotic agent
TETRACYCLINE :(ORAL LIQUID

PREPARATION)
CLASS : Antibiotic
STRUCTURE : (8)
11
IUPAC NAME : 2-(amino-hydroxy-

methylidene)-4- dimethyl amino-6, 10,11, 12a-
tetrahydroxy-6-methyl-4,4a,5,5a-
tetrahydrotetracine-1, 3, 12-trione(7)
MODE OF ACTION : The tetracyclines are

primarly bacteriostatic, inhibit protein synthesis
by binding to 30s ribosome in susceptible
organism. (1)
USES: It is used against veneral disease,

cholera, plague, brucellosis, rickettsial infection,
chlamydial infection. (1)
12
SIDE EFFECTS : Epigastric pain, nausea,

vomiting and diarrhea, liver damage, kidney
damage, photo toxicity, teeth and bones,
diabetes insipid us, skin rashes, urticaria. (3)
REASON FOR BEING BANNED : Tetracycline

oral liquid preparation produce TOOTH
DECOLOURATION, so restricted the use of
tetracycline in pregnant women and throughout
childhood. (5)
CHLORAMPHENICOL :
(FOR INTERNAL USE)
CLASS: Synthetic antibiotic.
STRUCTURE : (9)
13
IUPAC NAME : 2,2-dichlor-N-{(aR,bR)-b-

hydroxy-a-hydroxy-4-nitrophene ethyl}
acetamide. (7)
MODE OF ACTION : It inhibit bacterial protein

synthesis by interfering with transfer of the
elongating peptide chain to the newly attached
aminoaceyl- t-RNA at the ribosome m-RNA
complex.(1)
14
USES : It is used in enteric fever, for the

treatment of rickettsial infections such as rocky
mountain spotted fever. It is important
alternative therapy for meningitis. (2)
SIDE EFFECTS : Bone marrow depression,

hypersensitivity, gray baby syndrome, nausea,
vomiting, diarrhoea. (1)
REASON FOR BEING BANNED : Serious

blood dyscrasis and other toxic reaction like
bone marrow depression are resulted from the
chloramphenicol for internal use. (5)
YEAR OF BANNED: 3rd November, 1988.
MEPACRINE HYDROCHLORIDE :
CLASS : Polycyclic antimalarial drug.
STRUCTURE : (10)
15
IUPAC NAME : N4-(6-chloro-2-methoxy-9-

acridinyl)-N1,N1-diethyl-1,4-
pentanediaminedihydrochloridedehydrate. (1)
MODE OF ACTION : It acts at many sites within

the cell including intercalation of DNA strand,
succinic dehydrogenase mitochondrial election
transport and choline esterase. (1)
USES : It is an acridine derivative effective as

an anti-malarial drug. It is active against giardia
and tapeworms. (6)
SIDE EFFECTS : It is consider as most toxic

drug of antimalarial. It may be tumorigenic and
mutagenic. It produce nausea, vomiting, cramps
16
vertigo and rarely psychosis. Long term use

cause discoloration of skin and eye. (1)
REASON FOR BEING BANNED: Because of

the tumorigenic and mutagenic effect, so it is
banned in India. (7)
YEAR OF BANNED: 14th August, 1998.
TERBINAFINE HYDROCHLORIDE:
CLASS: Antifungal agent.
STRUCTURE : (11)
17
IUPAC NAME : N-(6, 6-dimethyl-2-hepten-

4ynyl)-N-methyl-1-napthalene-methanamine
hydrochloride. (1)
MODE OF ACTION : It acts by selectively

inhibiting the enzyme squalene epoxidase
which is involved in the synthesis of ergo sterol
from squalence in the fungal cell wall. (1)
USES : It is used for the treatment of tinea

pedis, tinea corporis and tinea cruris. (1)
SIDE EFFECTS : Gastro intestinal disturbance,

rashes, pruritusis, headache, cardiac
arrthymias, joint and muscle pain, rarely

hepatitis. (6)
REASON FOR BEING BANNED : Terbinofine

is more potent and has also demonstrated oral
18
activity against onychomycosis (ring worm of

the nails) so it is not approved for oral
administration. (1)
8-HYDROXYQUINOLINES :
CLASS : Anti-protozoal agent.
STRUCTURE : (12)
19
MODE OF ACTION : It is active against

entamoeba giardia, trichomonas, some fungi
and some bacteria. They killed the cyst forming
trophozoites in the intestine. (1)
USES : It has been widely used for the

prophylaxis and treatment of non-specific
diarrhea, traveller’s diarrhea, dietary
indiscretion, etc…(2)
SIDE EFFECTS : Nausea, transient loose and

green stools, pruritis, etc. Goiter has been
reported after prolonged medication. Iodism
may also occur. (5)
REASON FOR BEING BANNED : It is banned

only for pediatric patients because their used for
chronic diarrhoeas in children has cause
20
blindness. High dose for more than 14 days can

cause neuritis and optic damage. (5)
YEAR OF BANNED: 13th March, 1995.
NITROFURANS:
(EXCEPT FURAZOLIDONE)
21
CLASS : Synthetic anti-bacterial.
STRUCTURE : (13)
MODE OF ACTION : It have been used for the

treatment of bacterial infection of various kinds.
Anti-microbial activity is present only when the
nitro group is in 5th position. (1)
USES : used in the treatment of burns, for the

oral treatment of bacterial or protozoal diarrhea,
for the treatment of urinary tract infection. (1)
22
SIDE EFFECTS: mutagenic, carcinogenic,

gastrointestinal disturbance, nausea, vomiting
and anorexia, skin rashes, haemolytic aneamia
and polyneuritis, hypersensitivity reactions has
been observed. (6)
REASON FOR BEING BANNED : Due to

mutagenic, genetotoxicity, carcinogenic. It is
banned in India except furazolidone. (7)
YEAR OF BANNED: 13th August, 2003
NITROFURANTOIN WITH
TRIMETHOPRIM:
CLASS : Synthetic anti-bacterial activity.
STRUCTURE : (14, 15)

23
IUPAC NAME : 1-(5-nitro-2-furfurylidene)-1-

amino hydantoin. (1)
IUPACNAME: (5-[(3,4,5-trimethoxyphenyl)
methyl]-2,4-pyrimidinediamine. (1)
MODE OF ACTION : It shows anti- microbial

activity. A macro crystalline form is claimed to
improve gastrointestinal tolerance without
interfering with oral absorption. (1)
24
USES : It is recommended for the treatment of

urinary tract infection caused by susceptible
strains of E-coli, enterococci, S.aureus and
klebsiella, enterobacter and proteus spp. (4)
SIDE EFFECTS: gastrointestinal disturbances

like anorexia, nausea, vomiting, hypersensitivity
reactions (rashes, hepatitis, hemolytic anaemia)
is observed . (1)
REASON FOR BEING BANNED: Nitrofurantoin

and trimethoprim both are bacterostatic and
have synergistic effects .Trimethoprim require
alkaline urinary pH for its action and at this pH
anti-bacterial activity of nitrofurantoin is lost.
Acidic pH is favorable for nitrofurantoin activity,
Trimethoprim which is a weak base is ionized
and exert rapidly.During therapy it is difficult to
adjust pH which will favour the antibacterial

activity of both compound. For all these reasons
it is banned in India. (7)
25
YEAR OF BANNED: 1ST January, 2002.
ISONIAZID WITH ETHAMBUTOL :

CLASS : First line agent of anti-tuberculosis
agents.
26
STRUCTURE : (16, 17)
IUPAC NAME : Isonicotinyl hydrazide (1)
IUPAC Name: (+)-2,2’-(ethylenediimino)-di-1-

butanol(1)
MODE OF ACTION : Isoniazide is inhibit the

synthesis of mycolic acid, high molecular
weight, branched β-hydroxy fatty acid that
27
constitute important compound of the cell wall

of the myco bacteria. (1)
USES : It is most effective compound and

penetrates intracellularly into macrophages as
well as necrotic centres. It is remarkably
effective against tuberculosis.(6)
SIDE EFFECTS : Peripheral neuritis, gastro

intestinal disturbance like constipation, loss of
appetite and hepatotoxicity. (1)
REASON FOR BANNED : Isoniazid (200mg) +

ethambutol (600mg) and Isoniazid (300mg) +
ethambutol (800 mg) is banned because the
incidence of hepatotoxicity is higher in these
doses. (1)
ANTI-TUBERCULOSIS WITH
VITAMINS: (EXCEPT ISONIAZID WITH
PYRIDOXINE HCL)
28
MODE OF ACTION : It inhibit mycolase

synthetase require for high molecular weight of
branched β-hydroxy fatty acid. It effective
against mycobacteria and also against semi-
dormant intracellular tuberculebacilli. (1)
USES : Used for tuberculosis meningitis, used

in the erythema, also for neuritic complication
associated with leprosy. (3)
SIDE EFFECTS : Neurotoxicity, peripheral

neuritis, GIT disturbances, hepatotoxicity,
nausea, vomiting, abdominal pain, body
dyscrasias. (2)
REASON FOR BEING BANNED : Anti-TB with

vitamins cause principle toxic reaction like
peripheral neuritis and hepatotoxicity because
of the antagonism of the co-enzyme action of

pyridoxal phosphate.
29
Pyridoxine HCl is reported to prevent the

symptoms of peripheral neuritis without interfere
the anti-TB effect.(1)
PENICILLIN (SKIN / EYE OINTMENT)

CLASS : Anti-bacterial Anti-biotics
STRUCTURE : (18)
30
IUPAC NAME : 6-aminopenicillanic acid.(1)
MODE OF ACTIONS : Penicillin inhibit bacterial

cell wall formation. It is bactericidal in action. It
is more effective on actively multiplying
organism. Penicillin inhibit the enzyme
transpeptidase. It also inhibit peptidoglycan
synthesis and inhibits penicillin binding protein
at the cell wall causing lysis of the bacterial cell

through autolyzing enzyme. (6)
USES : Pneumococcal infection like

pneumonia, empyema and meningitis. Also for
syphilis, gonorrhea, anthrax, gas gangrene. (1)
31
SIDE EFFECTS : Flushing, pruritis,

hypotension, asthma, local inflammatory
eruption, thrombocytopenia, Jarisch Herxheimer
reactions (increased sensitivity of syphilitic
infection), hyperkalamia. (6)
REASON FOR BEING BANNED: Topical use

of penicillin is highly sensitizing it contact
dermatitis and other reaction so all topical
preparation of penicillin have been banned
except for use in eye as solution in case of
gonococcal opthalamia. (5)
Additional Information Of Banned

Drugs:-
The names of the drugs that are prohibited for
manufactures and sale through gazette notification
under section 26A of DRUGS AND COSMETICS
32
ACT, 1940 by Ministry of Health and Family Welfare

are listed below :-
1. Fixed dose combination of penicillin with

sulfonamides
2. Fixed dose combination of tetracycline with

vitamin C
3. Oxytetracycline liquid oral preparation
4. Demeclocycline liquid oral preparation
5. Fixed dose combination of Streptomycin

with penicillin
6. Fixed dose combination of Nalidixic acid

with any anti-amoebic including
metronidazole
33
CONCLUSION :
The safety of health of a patient from drug is a

vital aspect during treatment. The health
professionals, physicians, pharmacists and
nurses have to prescribe, handle and
administer the medicine properly.
34
To ensure maximum safety and security, it is

advisable to get only drugs prescribed by
medical practioner. Also ask for the details like
the name of the compound, expiry date, side
effects.
So people must buy medicine from a

recognized drug store.
35
REFERENCES :
1. Text book of Organic Medicinal and

Pharmaceutical Chemistry; Wilson and
Gisvold, 10th edition, 2001-2002.
36
2. Pharmacology and Pharmacotherapeutics;

R.S.Satoskar, Revised 16th edition, 1999.
3. Essential of Pharmacotherapeutics;
F.S.K.Barar, 4th edition, 2007.
4. Essential of Medical Pharmacology;

K.D.Tripathi, 4th edition(updated), 2001.
5. Essential of Medical Pharmacology;

K.D.Tripathi, 5th edition, 2003
6. Elements of Pharmacology; Derasari and

Gandhi, 18th edition, 2008-2009.
7. www.google.com
8. http://en.wikipedia.org/wiki/Tetracycline
9. http://en.wikipedia.org/wiki/Chloramphenicol
10. http://en.wikipedia.org/wiki/Mepacrine
Hydrochloride
11. http://en.wikipedia.org/wiki/Terbinafine
Hydrochloride
37
12. http://en.wikipedia.org/wiki/Hydroquinoline
13. http://en.wikipedia.org/wiki/Nitrofurans
14. http://en.wikipedia.org/wiki/Nitrofurantoin
15. http://en.wikipedia.org/wiki/Trimethoprim
16. http://en.wikipedia.org/wiki/Isoniazid
17. http://en.wikipedia.org/wiki/Ethambutol
18. http://en.wikipedia.org/wiki/Penicillin
19.C:/Documents &study/Admin/Desktop/killer
pills Banned but available.htm
38

Usage of Chemotherapeutic Banned Drugs in India

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Usage of Chemotherapeutic Banned Drugs in India

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Usage of Banned Drugs in India

Sale of spurious and banned drugs is rampant

attitude of the buyers. Even then, a large population

Definition of Banned Drugs :- The drugs those

History :- More than 60,000

Though the drug is approved by Drugs

aspects such as therapeutic effect, side effect, toxic

prescription practice in consideration of drugs

Among the studied prescription the most

According to our country, after amendment of

Till the date the Indian government has banned

drugs and their combination with other drugs for its

Chemotherapeutic agents are chemicals that

These are the agents which are concerned with

These are the agents which are capable of

It is the treatment of systemic infection /

toxicity for the infecting organism / malignant cell

 Synthetic Anti-bacterial agent

TETRACYCLINE :(ORAL LIQUID

IUPAC NAME : 2-(amino-hydroxy-

MODE OF ACTION : The tetracyclines are

USES: It is used against veneral disease,

SIDE EFFECTS : Epigastric pain, nausea,

REASON FOR BEING BANNED : Tetracycline

IUPAC NAME : 2,2-dichlor-N-{(aR,bR)-b-

MODE OF ACTION : It inhibit bacterial protein

USES : It is used in enteric fever, for the

SIDE EFFECTS : Bone marrow depression,

REASON FOR BEING BANNED : Serious

YEAR OF BANNED: 3rd November, 1988.

IUPAC NAME : N4-(6-chloro-2-methoxy-9-

MODE OF ACTION : It acts at many sites within

USES : It is an acridine derivative effective as

SIDE EFFECTS : It is consider as most toxic

vertigo and rarely psychosis. Long term use

REASON FOR BEING BANNED: Because of

YEAR OF BANNED: 14th August, 1998.

IUPAC NAME : N-(6, 6-dimethyl-2-hepten-

MODE OF ACTION : It acts by selectively

USES : It is used for the treatment of tinea

SIDE EFFECTS : Gastro intestinal disturbance,

arrthymias, joint and muscle pain, rarely

REASON FOR BEING BANNED : Terbinofine

activity against onychomycosis (ring worm of

MODE OF ACTION : It is active against

USES : It has been widely used for the

SIDE EFFECTS : Nausea, transient loose and

REASON FOR BEING BANNED : It is banned

blindness. High dose for more than 14 days can

YEAR OF BANNED: 13th March, 1995.

CLASS : Synthetic anti-bacterial.

MODE OF ACTION : It have been used for the

USES : used in the treatment of burns, for the

SIDE EFFECTS: mutagenic, carcinogenic,

REASON FOR BEING BANNED : Due to

YEAR OF BANNED: 13th August, 2003

STRUCTURE : (14, 15)

IUPAC NAME : 1-(5-nitro-2-furfurylidene)-1-

MODE OF ACTION : It shows anti- microbial

USES : It is recommended for the treatment of

SIDE EFFECTS: gastrointestinal disturbances

REASON FOR BEING BANNED: Nitrofurantoin

adjust pH which will favour the antibacterial