Dear E-druggers
The question from Pascal Verhoeven is actually two questions:
Firstly, about patents: Drugs which are still under patent to their
parent companies, like ciprofloxacin and Bayer, are nevertheless
produced in some countries which do not have legislation to protect
international patents. According to the SCRIP Generic Medicines
Review 1996, the Indian Patents Act 1970 (which allows copies of
products like ciprofloxacin to be produced in India by Indian
companies) remains in force until 2005, unless amended earlier -
which may happen under pressure from GATT/TRIPS. Such generic
copies will attract litigation from the company holding the patent
if they enter any country which respects the validity of the patent
eg. if they were to be brought into the UK. Ciprofloxacin is
Bayer's biggest turnover product - no doubt they will wish to
protect their patent as much as they can. I do not know when the
patent for ciprofloxacin expires, but it does not appear in a SCRIP
list for 1996-98. Hence the absence of a cheap generic
ciprofloxacin from ECHO's and (I guess) IDA's price lists. The
company mentioned as a source in the UK is a chemical and
pharmaceutical trader, not a manufacturer. The firm "Tablets India"
is unknown to me; the "mfg.licence number" on the labels refers to
the manufacturer's licence issued to the company by the Indian
authorities - the first three letters indicate which Indian State
issues the licence eg. GUJ is GUJARAT - the number is NOT specific
to the individual product, only to the company.
The second question is about how to ensure the quality of generics,
which is different from the legal question of ensuring that patent
rights are not being broken when a new generic comes onto the
market. Laboratory testing is one approach, but is only capable of
providing a 'snapshot' view of the products - it needs to be backed
up by a regular checking system for products and by gathering
information about the manufacturers and about the quality of
surveillance by the authorities in the country of manufacture.
Unfortunately, this information is not freely circulated because
traders and suppliers are nervous about sharing information which
might give them an edge over their rivals in a very competitive
market. Additionally, the situation with pharmaceutical companies
is constantly and frequently changing - a company that was OK just
yesterday may have been taken over and not be OK today. Although a
central databank appears attractive, I think it would be a nightmare
to set up and maintain - it would not itself be reliable.
Has anyone else any ideas to offer?
-------------------------------------
Carolyn Green, Sen.Pharm.Adviser
ECHO International Health Services,
Ullswater Crescent, Coulsdon, Surrey CR5 2HR UK
Phone: 44(0)181 660 2220 Fax: 44(0)181 668 0751
E-mail:
pharm.adviser: advisers@echointl.demon.co.uk
general: cs@echohealth.org.uk
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