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
antiallergy 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.
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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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