[india-drug] Nimesulide

[E-drug <e-drug@usa.healthnet.org>]

E-drug: Drug linked to child deaths is still available in India
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[The world has still a long way to go in drug safety... One rapid
response
inserted at the end of this news item. Copied as fair use. KM]

BMJ 2003;326:70 ( 11 January )
http://bmj.com/cgi/content/full/326/7380/70

Drug linked to child deaths is still available in India
Sanjay Kumar New Delhi

A drug known to have serious side effects and which has been banned in
parts of Europe is still available in India, despite reports in the
press of several deaths in the subcontinent among children who had been
taking it.

There has been a media furore in India over reports of adverse
reactions to nimesulide, a non-steroidal anti-inflammatory drug, which
has been reported as causing liver toxicity. Although it was approved
for use in India in 1994 for painful inflammatory musculoskeletal
disorders, it is often used for pain relief and fever.

Dr Chandra Mohan Gulhati, editor of India?s drug information bulletin,
the Monthly Index of Medical Specialities, said that the drug had not
been approved in the United States, parts of Europe, Canada, or
Australia and that last year it was banned in Finland, Spain, and
Turkey. "But it continues to be marketed with impunity in India," he
said.

After the media outcry, the drugs controller general of India, Ashwini
Kumar, said on television that the government was appointing a
committee to look into the issue of adverse reactions to the drug.

The deputy drugs controller, Ram Teke, however, told the BMJ that the
drug continues to be available and there was no move to reconsider its
use or approval.

The monthly index puts the national drug turnover to be some 1900
million rupees (£24.5m; $39.5m; ?37.6m). Besides being available as a
single ingredient, nimesulide is also available in more than 30 other
drugs and as drops for children aged under 1 year. All are unapproved
by the drugs controller and therefore illegal.

"There is no system of monitoring adverse drug reactions in India worth
the name," says Dr Gulhati. The monthly index lists 12 drugs that are
banned globally or whose use is severely restricted or not approved
owing to serious side effects but which are freely available in India.
These include anagen, cerivastatin, droperidol, furazolidone,
lynestrenol, nitrofurazone,phenformin, phenolphthalein, phenylbutazone,
piperazine, quiniodochlor.

But even though it has banned the drugs, India?s record of implementing
any such ban is phenomenally poor, says Dr Gulhati. He cites the case
of
anti allergy drugs astemizole and terfenadine, which hit the headlines
last year. A decision to ban them was announced in June, but the
notification was issued only in October?and the notification said the
ban would come into effect only in August 2003.

?This is the most absurd thing I have ever come across in my life,"
said Dr Gulhati. "If the drug is bad and harms people?s health, you ban
it with immediate effect." Such decisions are taken only to help the
manufacturers, he added. He lists commercial interests of the
pharmaceutical lobby, corruption, and total lack of accountability and
transparency as the key ailments affecting the drug regulatory
mechanism in India.

Adverse media reaction has resulted in two companies reportedly
announcing cuts in the manufacture of nimesulide.

Ajay Kumar Handa, president of marketing for the Bombay based Centaur
Pharmaceutical, said: "We are no longer supplying nimesulide
suspension." He said that Mr Handa says their decision follows reports
of paediatric hepatotoxicity and added: "As far as I understand there
is no problem with adult doses of nimesulide." Some other manufacturers
too have withdrawn the product, Mr Handa confirmed.

A public interest petition filed in December 2002 in Delhi High Court
by the Social Jurist legal group has challenged the availability of
nimesulide and other banned drugs in India.
-------------------------------------
Rapid response from:
Shailendra Goswami,
DNB trainee, general medicine
Lisie hospital, Ernakulam

Dear Sir, It is very unfortunate that such things happen here.

Rather than worrying about the consequences, or cursing someone
regarding this problem, I would like to request medical council of
India, or Indian medical association to start weekly newsletters by
email to all the doctors in India informing them about latest
proceedings in medical field, especially about drugs. It will be a
great help and can solve many problems,because, I feel, the root cause
of all the problem is lack of information among doctors. They are too
busy to update themselves, and we can't expect medical companies to
educate them regarding issues like toxic effects of their drugs.

MCI and IMA should take the responsibility. I would be happy to see a
positive response.

I must thank Sanjay for writing this article. It is really good.

Competing interests:   None declared







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