# \[e-drug\] Generic substitution (cont'd)

**URL:** <https://talk.edrugplus.org/t/e-drug-generic-substitution-contd/17794>\
**Category:** e-drug\
**Created:** [October 3, 2003, 9:51pm UTC](https://talk.edrugplus.org/t/e-drug-generic-substitution-contd/17794 "2003-10-03T21:51:26Z")\
**Posts on this page:** 1\
**Page:** 1

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**Author:** ![Francisco\_Rossi](https://avatars.discourse-cdn.com/v4/letter/f/50afbb/32.png) [@Francisco\_Rossi](https://talk.edrugplus.org/u/Francisco_Rossi)\
**Post date:** [October 3, 2003, 9:51pm UTC](https://talk.edrugplus.org/t/e-drug-generic-substitution-contd/17794/1 "2003-10-03T21:51:26Z")

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E-drug: Generic substitution (cont'd)  
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Dear Friends:

We have discussed this topic a lot in Colombia. A very tough and  
controversial discussion. Some argue that a "truly Generic" drug must  
show bioequivalence, in order to be interchangeable with the original.  
If not, it is a "copy" or a "similar" drug. And like it or not, the possibility  
of substandard quality is always present. I'm afraid WHO's position  
and documents may contribute to this point of view. In Mexico and  
Brazil, it is the official position and legal situation.

Our opinion, in Colombia's MOH and the drug quality control agency  
(INVIMA) is as follows: Generics are necessary and desirable to  
introduce competition for same products. But interchangeability is not  
a health objective. In fact any physician is interested in changing  
drugs day by day, pill by pill. Just to have options when to start (and  
end) a therapy. Interchangeability is a condition present in countries  
with a large patent experience in the market. Generic alternatives  
must show the same distribution profile to enter into the market, when  
the patent finishes. But developing countries are very different.  
Today, you can find two or three alternatives of one "original" drug.  
Interchangeability from whom and to whom?

With narrow therapeutic margin drugs the situation is more clear.  
Switching from one drug to other is not recommended. Even original  
to generic, or generic to original. In fact we strongly recommend not  
to change the manufacturer's drug without clinical follow up. Or we  
sometimes prohibit a change. Maybe this is a good recommendation  
in therapies for chronic diseases.

Bioequivalence tests, especially in vivo, just have a very short scope  
of application: oral dosage forms, narrow therapeutic margin and  
dissolution problems. Maybe 30 drugs?

In this context, substitution or prescription in INN are the same. In our  
experience there is a very strong effort by the research based  
industry to generate artificial (technical) barriers to competition. And  
to suggest diferent standards of quality.

We would very much appreciate your opinions on this topic.

Thanks a lot,

Francisco A. Rossi. B.  
Advisor  
Ministerio de Proteccion Social, Colombia  
Carrera 13 No 32-76  
Tel +57-1-3365066 ext 2229  
fax +57-1-3360165  
e-mail: francisco\_rossi@hotmail.com

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