[india-drug] [e-drug] rofecoxib ban in India (3)

["INDIA-DRUG" <india-drug@healthnet.org>]

Date: Sun, 24 Oct 2004 21:01:27 +0530
From: "Raj" <pharmhin@sancharnet.in>
Subject: [e-drug] rofecoxib ban in India (3)
In-reply-to: <FDEOKNEELFDLADFHEGNKCEMOCHAA.wjb@wxs.nl>
To: Essential Drugs in English <e-drug@healthnet.org>
Message-id: <6.0.1.1.0.20041024202328.07131ce0@wmma.sancharnet.in>

E-DRUG: rofecoxib ban in India (3)
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MERELY SAYING THAT A DRUG IS BANNED in India is not sufficient. It needs 
clarification whether it is banned for further production, or is it banned 
for retail sale ? Because, if it only banned for production, then it could 
mean that existing stocks in the market can be liquidated.

If I am not mistaken, the US FDA had given a period of  about 3 months for 
withdrawal of Cisapride from the shelves of chemists.)

If the ban/withdrawal order  in India specifically states that Rofecoxib 
cannot be sold AFTER a particular date, then also there are chances that 
Rofecoxib may be available for few/many days after that date, because of 
various practical reasons in the country :

1. Our country does not have a well designed drug Recall system.

2. There is no mechanism by which official correspondence compulsorily 
reaches every wholesaler & retailer in the country (we have 1/2 a million 
of them).

3. Drug Inspectors cannot reach out & inspect every chemist/wholesaler to 
check for stocks of Rofecoxib, because Drug Inspectors are too few.

4. Even if chemists receive a communication to return all stocks of 
Rofecoxib, and the chemist honestly attempts so, there is a possibility, 
that some brand/s of Rofecoxib may remain in some corner/shelf of his 
pharmacy, because he just may not be aware/remember of its existence in his 
pharmacy.

5. But, it is almost assured, that production of a drug ceases immediately 
after an order says so (unless the manufacturing companies get a reprive 
after appealing, from the Courts, which permits them to continue 
manufacture of drugs till their raw material is exhausted).

Till date, besides Dr. Gulati's statement that Rofecoxib has been banned in 
India, I have not seen or  heard of any such communication. Probably the 
communication is there, but I, a well versed, motivated, communicated, 
practising pharmacist have till this moment not heard of it or received it.

What communication I have read/heard is that the National Pharmacovigilance 
Advisory Committee (NPAC) has recommended that Rofecoxib should be 
withdrawn in India,  and accordingly, the member Secretary of this 
Committee, the DCGI would issue the necessary orders. Till the orders are 
issued, Rofecoxib is NOT banned in India ! If Ranbaxy (& of course other 
companies are also doing it) has announced withdrawal of stocks before this 
order, then it technically & legally means that Ranbaxy has voluntary 
withdrawn Rofecoxib !!!! A feather in their cap (technically & legally) !!!!

It is incorrect of Dr. Anupam Aggarwal to say that Nimesulide is available 
in India even after banning it, because the fact remains that Nimesulide is 
NOT YET BANNED in India!

Our country needs revamp in our system, but unfortunately, there are also 
many hurdles and parameters which obstruct authorities from functioning 
smoothly and strictly.

Raj Vaidya, M.Pharm,
Community Pharmacist,
Hindu Pharmacy,
Cunha Rivara Road, P.B.No. 149,
Panaji - Goa - India 403001.
Tel : 91-832- 2223176, 2432903 (O), 2463926 (R).
Email : pharmhin@sancharnet.in  

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