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AWARENESS ABOUT BANNED DRUGS: A REVIEW
*R. Soni, V. Singh, G. K. Sharma, N. Dashora and A. Dashora
Geetanjali Institute of Pharmacy, Udaipur 313001 (Raj.) India
Received : 19/06/2015 Revised: 05/07/2015 Accepted : 22/07/2015
ABSTRACT:
India has become a dumping ground for banned drug, also the business for production of banned drug is booming. All
the formulations are meant for prevention or treatment of ailments and diseases, out of which only a few drugs are
lifesaving and essential, rest of the drugs are substitutes of each other. Banned drugs are still available in developing
countries like India due to lack of law enforcement physician awareness and the drug control authorizes fails to inform
all the hospital of the status of medicine. Some of the dangerous drugs have been globally discarded but are available in
India. The most common are like NIMESULIDE, FURAZOLIDONE, PHENYLPROPANOLAMINE and other over the counter
preparation are banned by US FDA due to their side effect on kidney, liver and nerve. Unfortunately analgesic, anti-
diarrheal and cough preparations which are banned in other countries and are blindly used in India as over the counter
drugs because of unawareness, lack of law enforcement and corruption. The Government of India is in the process of
developing a regulatory regime designed to ensure the quality, safety and performance of medical devices. The
pharmacist should take interest in public information campaigns and educate consumers and thus can play an important
role of eliminating the banned drugs from market.
Keywords: Banned Drug, Indian Drug, Nimesulide, FDA
INTRODUCTION
A drug is “a chemical or synthetic substance used in the,
cure, prevention or diagnosis of disease or used to
otherwise enhance physical or mental well being.
BANNED DRUGS- banned drugs are drugs that not
allowed to intake because they could artificially
improve their performance and shows various adverse
effects more than therapeutic effects. Whose production
or use is prohibited or strictly controlled via
prescription.
“Drug Controller general of India” is the highest
authority in India to expand the approval of any drug or
to ban a drug. Some of the dangerous drugs have been
globally discarded but are available in India. The most
common are like NIMESULIDE,
PHENYLPROPANOLAMINE, FURAZOLIDONE, etc1.
REASON FOR BANNING A DRUG -
Drugs undergo rigorous testing before they are
introduced into the market. The efficacy as well as
safety profiles of the drug are tested. In spite of this,
some adverse effects of drugs appear only after the drug
is released called
PHARMACOVIGILANCE
PHARMACOVIGILANCE is the Pharmacological science
relating to the detection, assessment understanding and
prevention of adverse effects, particularly, long-term
and short-term side-effects of medicines2.
“Drug Controller general of India” is the highest
authority in India to expand the approval of any drug or
to ban a drug. If any is to have harmful side-effects, the
government issues the ban order and all manufacturer
and wholesaler are asked not to stock the particular
medicine3.
“If doctors stop prescribing drugs that are harmful to
patients’ health, chemists will automatically stop selling
since there are no patients asking for it, and hence,
manufacturers do not produce it. Certainly, much of the
*Corresponding Author:
Mr. Ronak Soni
Geetanjali Institute of Pharmacy,
Udaipur 313001 (Raj.) India
Email: rssoni1998@gmail.com
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problem can be solved like that, ‘the manufacturers
have every reason to sell their products if there are
buyers.”
WHY INDIA STILL SELLING BANNED DRUGS
India has become a dumping ground for banned drugs.
The irony is that very few people know about the
banned drugs and consume them unaware, causing a lot
of damage of themselves. The issue is severe and we
must not delay in spreading the warning message to the
offenders and innocent people4.
MOST OF THE DRUGS BANNED IN OTHER COUNTRIES
BUT AVAILABLE IN INDIA
Oxyphenbutazon: Oxyphenbutazone, a metabolite of
phenylbutazone,is an NSAID. It has been used for
episceleritis, osteoarthritis, and rheumatoid arthritis
etc. the severe adverse effects of oxyphenbutazone,
which give rise to further complications include allergic
reactions, abdominal pain, blurred vision.
Metamizole: Metamizole (Dipyrone) belongs to a group
of drugs that eliminate pain and reduce fever.
Metamizole can cause damage to the bone marrow
(granulocytopenia, agranulocytosis, hemolytic anemia,
aplastic anemia.) , digestive disorders etc.
Cisapride- Cisapride is a “PROKINETIC AGENT” that
used for treatment of gastroesophageal reflux disease
(GERD). There is no evidence it is effective for this use
in children. evidence for its use in constipation is not
clear. It has been found to cause cardiac arrhythmias
(irregular heart rhythms)
Nimesulide: Nimesulide is a non-steroidal anti-
inflammatory drug, used for painful inflammatory
conditions, back pain, dysmenorrheal, postoperative
pain, osteoarthritis and fever. Caution should be
exercised in patients with history of stomach problem ,
high blood pressure, fluid retention, abdominal
discomfort, heartburn, abdominal cramps, nausea,
vomiting and diarrhea, headache, dizziness and
drowsiness, blood in urine and kidney failure.
Phenylpropanolamine: Phenylpropanolamine is a
“PROKINETIC AGENT” that used for treatment of
gastroesophageal reflux disease (GERD). But heart
stroke and heart attack can cause due to adverse effect
of phenylpropanolamine.
Quiniodochlor: Quiniodochlor is a antibacterial agent,
used for dermatophytosis, mycosis barbae, seborrhoeic
dermatitis, infected eczema, furunculosis, and pityriasisi
veriscolor. It caused to nausea, transient loose and
green stools, itching and goiter.
Cerivastanin: Cericastatin prevents the risk of stroke
and heart attack .it functions by blocking away the
enzymes in the liver that is responsible in the
production of cholesterol inside the body. There are
several side effects associated by using CERIVASTATIN,
for example- diarrhea, nasal congestion, constipation,
headache and heartburn, muscle damage, sexual
problems, fever, difficulty in breathing etc.
Droperidol: Droperidol is an Antidopaminergic drug
used as an antiemetic and antipsychotic. It also often
used for neuroleptanalgesic anesthesia and sedation in
intensive-care treatment. but it causes dysphoria,
sedation, hypotension resulting from peripheral alpha
adrenoceptor blockade, prolongation of qt interval
which can lead to extra pyramidal side effects such as
dystonic reaction.
Furazolidone: Furazolidone is a Nitrofuran
Antibacterial. It is marketed under the brand name
furoxone. furazolidon has been used in human and
veterinary medicine. in humans it has used to treat
diarrhea and enteritis caused by bacteria or protozoan
infections. it has been used to treat cholera and
bacteremic salmonellosis, and helicobacter pylori
infections. it has many side effects, and as with other
nitro furans generally, minimum inhibitory
concentrations also produce systemic toxicity (tremors,
convulsions, peripheral neuritis, gastrointestinal
disturbance, depressions of spermatogenesis.)
Nitrofurazone: Nitrofurazone is bactericidal for most
pathogens that commonly cause surface skin infections.
Topical nitrofurazone is indicated as an adjunctive
therapy second and third degree burns. The adverse
effects have been selected on the basis of their potential
clinical significances are itching, rash and swelling.
Thioridazine: Thioridazine is an antipsychotic medicine
called a phenothiazine. It is used to treat schizophrenia.
But it can cause a life-threatening heart rhythm
disorder, uncontrollable muscle movements of your
lips, tongue, eyes, face, arms or legs.
Pergolide: Pergolide is a drug normally used for the
treatment of parkinson’s disease. But cardiovascular
system can damaged as the adverse effect of pergolide.
Piperazine- Piperazine was introduced to medicine as a
solvent for uric acid. PIPERAZINE was first introduced
as an anthelmintic. piperazine is used in the treatment
of worm infections. following side effects can causes the
human body: blurring of vision, clumsiness, crawling or
tingling feeling of the skin, fever, irregular, twisting
movement, especially of the face, arms and legs, joint
pains, and itching or skin rash etc. .
Phenolphthalein: Phenolphthalein is a astringent
normally used as a laxative. The several adverse effects
of phenolphthalein are heart stroke and heart attack etc.
Tegaserod: Tegaserod is a medicine used to treat severe,
chronic, irritable bowel syndrome (IBS) in women who
have constipation (and not diarrhea) as their main
bowel problem. But it causes to new or worsening
stomach pain, blood in stools, ongoing diarrhea, severe
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stomach pain or cramps, headache, dizziness, or
migraine, back pain or joint etc.
Analgin: Analgin is a medicine of pyrazolone group
possessing hard analgesic and antipyretic effects and
moderate anti-inflammatory activity and used for the
treatment of pains of different origin and variable
intensity: toothache, headache, arthralgia, myositis,
mild to moderate visceral pain, high fever. After prolong
administration very rarely can be observed
agranulocytosis, leucopenia, and thrombocytopenia,
proteinuria, interstitial nephritis. In sensitive patients
rashes, urticaria, quincke’s edema, asthmatic attacks,
and very rarely anaphylactic shock are possible5.
REGULATIONS & GUIDELINES:
Process of banning drug in India is done by DTAB (Drug
technical advisory board) which is the final authority on
imposing a ban. Drug controller general of India notifies
all state drug authorities and manufacturer about ban
on the drug. At IPA we understand the problems faced
by pharma professionals in accessing requisite
information in order to comply with the regulatory
requirements At home and in the regulated foreign
markets. We’ve tried to simplify things for you by
assembling the important Indian and international
guidelines and regulations in this section.
SUMMARY AND CONCLUSION
Though each country has its own list of banned drugs, it
is worrisome that some drugs that are banned in other
countries for proven adverse effects are still available in
the Indian market. Some of these drugs are available
over – the – counter and people may take it without
realizing the risk. A note of caution on these drugs could
help patients in deciding whether they want to take the
drug6. Please make sure that patients buy drugs only if
prescribed by a doctor. And that also from A reputed
drug store. Not many people know about these banned
drugs and consume them causing a lot of damage to
themselves. For illegal drugs that are not diverted
prescription controlled substances, some critics believe
that illegal recreational use is inherently irresponsible;
due to the unpredictable and unmonitored strength and
purity of drugs are the risks of addiction, infection, and
other side effects7.
The Central Drugs Standard Control Organisation run
by the government of india has to made a strict
guidelines over the list of drugs have been banned by
European union and USA.
RESULT
1. World Health Organisation. WHO expert committee
on drug dependence. Sixteenth report (Technical
report series. No 407). Geneva: World Health
Organisation 1969.
2. The importance of pharmacovigilance safety
monitoring of medicinal products. World Health
Organisation 2002;44
3. Gulhati CM. government commission identifies
useless, hazardous, irrational drugs. Monthly Index
of Medical Specialities, India Nov 2005.
4. Monthly index of medical specialities 5 apr 2008
5. http://www.indianexpress.com/; “All eyes on
banned drugs”, 2011.
6. Sharma G., Dixit a., Awasthi s., Awasthi A.K.; “Some
common Indian drug should be banned in India”
International Journal Of Pharmaceutical And
Clinical Research,July2011, 3(5),49-52.
7. Dogra S.; “Banned but available”,
http://www.expresspharmaonline.com/, Nov.
2012.