E-DRUG: Unethical drug promotion in India
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[HAI Europe had a campaign in the 1980's to get rid of "braintonics" like
piracetam and "appetite stimulants" like buclizine. There is hardly any
evidence that these work. However, there is also little evidence that they
don't work. The latter was needed to clean them from the European market due
to their status as "old" drug under European drug legislation. It is a
scandal that such drugs are wasting people's meagre resources in India! What
companies are involved? Local or international ones? WB]
Dear E-druggers,
India: Illegal, Unethical Promotion Hits New Highs
Indications Increased, Side Effects Suppressed
In clear violation of India's drug laws and medical
ethics, two medicines are being promoted aggressively
for unapproved indications. At the same time
information on side effects is being suppressed.
Piracetam is being promoted for unimaginably vague
conditions like "intellectual decay," "social
maladjustment," "lack of alertness," "changes of
mood," "deterioration in behaviour" and "learning
disabilities in children associated with the written
word." The recommended duration of treatment for the
last indication is "entire school year" in a dose of
"3g per day" i.e. 7-8 capsules of 400mg daily. If the
drug is administered for the entire school year as
recommended, it will mean parents buying at least
2,700 capsules every year. There cannot be a more
ingenious, albeit unethical method of increasing sales
even though it hurts the pockets of parents without
any benefit to children.
The unending claims of the drug's efficacy include
"the treatment of sickle cell anaemia," stroke and
vertigo.
In Britain, piracetam (Nootropil) is permitted for
use in just a single indication, a rare disorder
called cortical myoclonus, that too only as an
adjunctive therapy (Reference: British National
Formulary). While in India, the drug is being promoted
for use in young children, in Britain its use is
contraindicated for adolescents under the age of 16
years.
If the Indian company marketing piracetam is to be
believed, the drug is nothing short of nectar. It has
no contraindications, no need to observe any
precautions, no interactions and no adverse drug
reactions. In Britain, the drug is contraindicated in
hepatic and renal impairment, during pregnancy and
lactation. It is to be used cautiously in elderly. Its
side effects include: diarrhoea, weight gain,
insomnia, nervousness, depression, hyperkinesia and
rash. It can interact with warfarin and result in
bleeding. Piracetam is not marketed in the United
States.
Another drug, buclizine under the brand name of
Logifene is illegally and aggressively being promoted
as an appetite stimulant in very young children. It
was approved only as an antihistamine by Drugs
Controller General, India (DCGI). In January 1993, the
manufacturer decided on its own to discontinue its use
as an antihistamine and instead promote it as an
appetite stimulant without regulatory approval.
Buclizine's use has been restricted worldwide to the
treatment of migraine in combination with analgesics
in patients over the age of 10 years. In the United
States, the molecule was discarded in 1999. Before
being withdrawn in Switzerland in 1998, the drug was
indicated for use in motion sickness, nausea and
vomiting but contraindicated for use in adolescents
below 16 years. Internationally reported adverse
effects include: drowsiness, blurred vision,
diarrhoea, difficulty in passing urine, dizziness,
dryness of mouth, tachycardia, headache, nervousness,
restlessness, hallucinations, skin rash and upset
stomach. Bottles of Longifene, the only brand of
buclizine being sold in India do not contain either
the package insert or the patient information leaflet.
Thus Indian consumers are being deliberately deprived
of safety information. However the words "for increase
in appetite and weight gain" are boldly printed on the
bottle's carton!
Why do some companies in India openly resort to
illegal and unethical promotion of medicines? Because
they are neither fearful of law nor the law enforcers.
Even if an erring company is caught red-handed
indulging in illegal activities, it is let off, for
reasons best known to regulators, with a light warning
as happened in the case of letrozole. In the absence
of new molecules, pharma companies do the next best
thing: invent diseases, increase indications and
underplay side effects.
Dr. Chandra M. Gulhati,
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
90 Nehru Place,
New Delhi 110019.
India.
Tel: 91 11 26433115/26234875
Fax: 91 11 26463720/26424016
e-mail: seeemgee@yahoo.co.uk
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