[india-drug] Nimesulide put under focused pharmacovigilanceprogramme in India (4)

["bindu raol" <bindu_raol@yahoo.com>]

Nimesulide put under focused pharmacovigilanceprogramme in India (4)
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Dear members,
  copied in fair interest from e-drug...
  a response to the message...
   
      
   From: "ibnsinaacademy" <ibnsinaacademy@gmail.com>   
   Date: Sun, 9 Sep 2007 15:26:53 +0530 
  
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    E-DRUG: Nimesulide under focused pharmacovigilance in India (2)


  dear E-druggers,

The number of ADR reports is very minimal in India despite the National

Pharmacovigilance Program. There could be many ADRs on
Nimesulide-induced 
hepatitis or cardiovascular insufficiency, which are either not
reported or have been missed by health care professionals.  

At the same time, it is surprising to note the alleged claim of the
drug regulatory authorities of India that no ADR report had been received
to them on the use of Nimesulide in the country so far to necessitate a
review. There are many reports, letters and papers on this topic that
could be found in Indian newspapers and journals. 

We sent the following papers / CD to the office of the Central Drug
Surveillance Control Organization (CDSCO) for their information and
necessary action:

1). KC Singal and SZ Rahman. Nimesulide Induced Hepatitis in a child of
5
years: A case Report (Short Communication). Newsletter of Society of
Pharmacovigilance, India, 2003, pp 6-7.

2). SZ Rahman & RA Khan. Is nimesulide safe in a
cardiovascular-Compromised
patient? Indian J Pharmacol 2004; 36:252-253

3). RA Khan & SZ Rahman. Nimesulide Induced Coronary Artery
Insufficiency -
A Case Report. J Pharmacovigilance Drug Safety 2004; 1: 11-13

4). RA. Khan & SZ Rahman. A Case Report on Nimesulide and Its Relation
with
Angina. J Pharmacovigilance Drug Safety 2004; 1: 19-21

5). CD ROM, Appropriate Use of Antipyretics / Analgesics in Children,
Health Informatics, New Delhi, 2004

With kind regards,

Syed Ziaur Rahman, MD
Aligarh, 
India
ibnsinaacademy@gmail.com
   
   
  one more mail which available in archives of india-drug,
   
    
   From: Dr.Chandra.M.Gulhati.mims@del2.vsnl.net.in   
   Date: Tue, 18 Mar 2003 05:18:00 -0500 (EST) 
  
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Nimesulide
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Dear All,

While reading all the comments on Nimesulide, it is
noticed that many facts (not opinions) on this drug
are not widely known. Briefly,

1. Nimesulide was discovered by 3M Pharmaceuticals, an
American manufacturer at St. Paul, Minnesota, United
States. Therefore the origin of the molecule is United
States, where it is not approved.

2. As per latest figures, the total world
pharmaceutical market is worth US$ 460 billion out of
which US alone accounts for 50% i.e. US$ 130 billion,
Europe about 25% and rest of the world 25%. Indian's
share is US$ 3.8 billion or less than 1%. Why would an
American company not launch its research product in
its home country? All other products (except
Nimesulid)discovered by 3M Pharmaceuticals are being
marketed in USA. The cost of discovery of a molecule
is US$ 500 to US$ 800 million in USA. This kind of
research expenses can never be recovered without entry
to US market.

3. 3M Riker - the parent company of 3M Pharmaceuticals
- is worth US$ 17 billion and spends over US$ 1
billion every year on research. It sold the molecule
to a small private company in Switzerland called
Helsinn. Helsinn, instead of launching Nimesulide in
Switzerland, licensed the drug to Boehringer in Italy
where it was launched in 1985. In Italy, it is
licensed for use in musculo-skeletal inflammation and
accompanying pain only. Its use in children below 6
years is prohibited.

4. Nimesulide was launched in Switzerland, the home
country of Helsinn, in 1995 i.e. 10 years after Italy
based on the human data from Italy. The Swiss
Government permitted its use in adults only. Its use
in children below 12 years is prohibited.

5. Everyone connected with pharma business around the
world knows that introducing new molecules in USA,
Britian, Australia, Denmark etc. is not very easy
while it is not very difficult in Italy and Brazil.

6. Today Nimesulide is licensed for use in just under
40 countries which also means that it is not permitted
for use in just over 150 countries.

7. In South East Asia (Thailand, Malaysia, Singapore
etc), Nimesulide is permitted to be used only in
adults for "Musculo-skeletal inflamation accompanied
by hyperpyrexia (temperature above 106.7 degree F)"
and no other condition.

8. India is the ONLY country on earth where Nimesulide
drops are marketed for use in neonates and infants.
The only other country where nimsulide is permitted in
children (apart from Italy) is Brazil where it is
prohibited below 3 years.

9. As per Rule 122 (E) of the Drugs & Cosmetics Act
read with Schedule Y, all drugs require mandatory
prior permission from Drugs Controller, India (DCI).
Fresh permission is required if a new formulation of
approved drug is to be launched such as sustained
release etc. In India only two formulations are
approved i.e. 100mg tablet and 50mg/5ml suspension.
The following formulations are being marketed without
DCI permission: 50mg tablets for kids, 25mg/ml drops,
200mg tablets, 400mg tablets, 100mg EF tablets, 100mg
MD tablets. Even when one company obtains permission
for any formulation, another company needs fresh DCI
approval if introducing the same drug within 4 years.
Over 170 companies in India are marketing nimesulide
single ingredient formulations without mandatory DCI
approval.

10. ALL fixed-dose combinations of nimesulide with
other agents such as paracetamol, diclofenac,
tizanidine etc are being marketed without mandatory
DCI approval. This fact has been admitted by DCI in
reply to a starred question in Loksabha on 20-08-2000.
India is the ONLY country on earth where nimesulide
with other agents is being marketed.

11. The retail price of Nimesulide for 10 tablets
ranges between Rs. 14.50 to Rs. 29. It is not the
cheapest "analgesic" or "antipyretic." It is about 200
to 400% more expensive. Besides the cost price of 10
tablets of nimesulide 100mg is Rs. 1.80. As per
ORG-MARG data, no other NSAID has such a huge profit
margin.

12. Several laboratory, animal and human studies in
Canada and USA have shown that Nimesulide is
partially, but not fully, COX-2 Selective. Besides,
Nimesulide inhibits COX-1 much BEFORE and AT MUCH
LESSER SERUM LEVELS. Thus it is not gastro-protective.
This was one of the reasons for aborting an attempt to
get USFDA approval in 1998.

13. All studies submitted to DCI in India by
manufacturers of Nimesulide were sponsored and
financed by Helsinn - many of them actually written by
Helsinn employees.

I will be happy to provide references for above facts
to anyone who needs them.

Dr. Chandra M. Gulhati,
Editor, MIMS
e-mail: mims@ndb.vsnl.net.in 




   
  you may also visit the links below,
  http://www.doctorndtv.com/feature/detailarchivefeature.asp?id=84,
  http://www.doctorndtv.com/poll/newresult.asp?id=48
  KEM hospital ADR reporting,
  http://www.kem.edu/dept/clinical_pharmacology/adverse_event_month_case/case_august2004.htm

   
  Regards,
  Bindu Rao
bindu raol <bindu_raol@yahoo.com>

       
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