E-drug: Reply from Dr Attaran to Dr Srinivas (cont'd)
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Dear e-druggers,
I am very grateful for your support for my stand on this network and
for my part I look forward to learning from all your views, including
those of Dr Attaran, which may improve my capacity for decision
making in the future.
It appears from discussions, in response to my previous submissions
on drugs from developing countries, that in the medium and long
term, the developing countries need to improve the credibility of their
regulatory systems in general, in order to address this problem. In the
short term, perhaps, there is an opportunity for NGOs or even
individual governments to set up export certification agencies, which
could provide the guarantee certificates based on a superadded
system of certification based on quality check.
I use this opportunity to seek clarification on an issue of slightly
technical nature, viz, on the relevance of expiry dates of drugs and
the ways they are established. I have noticed that formulations of the
same drug may have different expiry dates depending on the
manufacturer. The date of expiry of a drug has great significance for
drug procurement and in many countries which are import dependent,
and the inventories large, close attention is paid by pharmacists and
hospital authorities to the date of expiry and there is a tendency not to
purchase any drug with less than a one and half years left for expiry.
In light of the above, I have some queries which I hope someone on
this network will be able to answer.
1. My first question would be, what are the constituents, other than
the active principle, which affect the date of expiry of a drug?
2. The constituents remaining the same, can the process of
manufacture affect the date of expiry of a drug?
3. How closely are these data (relating to date of expiry) verified by
regulatory authorities and what are the checks exercised on this
specific aspect?
4. Can it be assumed that products having the identical ingredients
(active as well as excipients) would have same date of expiry?
5. Whether this aspect would affect the pace of regulatory approvals
that need to be given for generic drugs or drugs that may be
manufactured under compulsory licenses?
Yours Sincerely,
Dr Srinivas
Ministry of Health
Delhi, India
(in personal capacity)
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