E-DRUG: Misleading Product License numbers in India?
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Dear (India-) E-druggers,
About a year ago I brought to the attention of e-drug the fact that
Indian Drug Regulatory Authorities (DRAs) from different states fill in
Manufacturer's License numbers (ML-numbers) where Product License
numbers (PL-numbers) are requested on the Certificate of Pharmaceutical
Product (CoPP, 2A.1). There is no remark on the CoPP that this is being
done. I am sorry to say that I did not receive any reaction.
The ML-numbers are issued per range of products and so you may find the
same ML-number for Glibenclamide, Furosemide and Methyldopa tablets on
the different CpPPs for each product and not distinctive PL-numbers. As
the criteria needed to make a proper judgement, if a product should be
allowed on the market are much more than only the criteria to judge if
the product is allowed to be manufactured according to standards (GMP),
I still think that this is not a good practice and that it may be
regarded as misleading.
I, again, like to express my appreciation for the opinion of my
colleagues on this, especially the relevant Indian authorities, who were
also approached by email directly, but did not react up to now.
Kind regards,
Rob Verhage
Member of the Suriname Drug Registration Committee
p/a PO Box 4002
Tawajakoerastraat 4
Paramaribo
Suriname
+597 438966
verhager@gmail.com