usage of chemotherapeutic banned drugs in india

Usage of Banned Drugs in India

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AIM OF WORK:-

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

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proper control of spurious drug in Indian markets. Worst than that is little knowledge and slap dash

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)

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Introduction

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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

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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

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drugs and their combination with other drugs for its

manufacturing and marketing in India.(7)

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Chemotherapy :-

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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)

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CLASSIFICATION OF

CHEMOTHERAPEUTIC AGENTS :-

Anti-malarial agent

Anti-fungal agent

Anti-viral agent

Anti-Protozoal agent

Anti-bacterial Anti-Biotics

Anti-Neoplastic agent

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Anthelmintics

Sulphonamides

Synthetic Anti-bacterial agent

Anti-leprotic agent

TETRACYCLINE :(ORAL LIQUID PREPARATION)

CLASS : Antibiotic

STRUCTURE : (8)

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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)

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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)

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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)

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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)

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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

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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)

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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

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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)

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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

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blindness. High dose for more than 14 days can

cause neuritis and optic damage. (5)

YEAR OF BANNED: 13th March, 1995.

NITROFURANS:

(EXCEPT FURAZOLIDONE)

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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)

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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)

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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)

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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)

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YEAR OF BANNED: 1ST January, 2002.

ISONIAZID WITH ETHAMBUTOL :

CLASS : First line agent of anti-tuberculosis

agents.

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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

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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)

MODE OF ACTION : It inhibit mycolase

synthetase require for high molecular weight of 28


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.

Pyridoxine HCl is reported to prevent the

symptoms of peripheral neuritis without interfere

the anti-TB effect.(1)

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PENICILLIN (SKIN / EYE OINTMENT)CLASS : Anti-bacterial Anti-biotics

STRUCTURE : (18)

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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)

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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

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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

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CONCLUSION :

The safety of health of a patient from drug is a

vital aspect during treatment. The health

professionals, physicians, pharmacists and

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nurses have to prescribe, handle and

administer the medicine properly.

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.

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REFERENCES :

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1.Text book of Organic Medicinal and

Pharmaceutical Chemistry; Wilson and

Gisvold, 10th edition, 2001-2002.

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

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http://en.wikipedia.org/wiki/Mepacrine

http://en.wikipedia.org/wiki/Chloramphenicol

http://en.wikipedia.org/wiki/Tetracycline

http://www.google.com/


11. http://en.wikipedia.org/wiki/Terbinafine

Hydrochloride

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

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http://en.wikipedia.org/wiki/Penicillin

http://en.wikipedia.org/wiki/Ethambutol

http://en.wikipedia.org/wiki/Isoniazid

http://en.wikipedia.org/wiki/Trimethoprim

http://en.wikipedia.org/wiki/Nitrofurantoin

http://en.wikipedia.org/wiki/Nitrofurans

http://en.wikipedia.org/wiki/Hydroquinoline

http://en.wikipedia.org/wiki/Terbinafine