# \[e-drug\] RFI: Bioequivalence and generics registration (7) **URL:** https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-7/19777 **Category:** e-drug **Created:** [June 5, 2004, 9:34am UTC](https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-7/19777 "2004-06-05T09:34:04Z") **Posts on this page:** 1 **Page:** 1
### Author: ![Lakhvinder\_Singh\_Bat](https://avatars.discourse-cdn.com/v4/letter/l/e19adc/32.png) [@Lakhvinder\_Singh\_Bat](https://talk.edrugplus.org/u/Lakhvinder_Singh_Bat) #### Post date: [June 5, 2004, 9:34am UTC](https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-7/19777/1 "2004-06-05T09:34:04Z")
E-DRUG: RFI: Bioequivalence and generics registration (7) --------------------------------------------------------- dear E-druggers, I totally agree with Milind that the Quality of Pharmaceutical products is more important than just the Retail price of Drugs. Why , we have price variances of the same product upto to 400% in some cases. The important issue is that the tablet/capsule contains the drug as per Label claim in the range of 80-120/125 %. Apart from this the GMP manufactured drugs would be more reliable than non-GMP drugs because of contamination, storage and handling issues. Online QC and QA procedures during raw material procurement to manufacturing take up a lot of resources, time, energy and money, which pushes up the prices of drugs. Market forces can only pull down the margins, but there is always a ceiling to price cuts. After all, manufacturing drugs is a business, and as all businesses needs a profit to survive and grow. Bio`s( in vivo tests) are the only means to assure that a formulation would behave in a way they are intended to inside the body. all the three parameters mentioned (Cmax, T 1/2 and AUC) are important parameters in a bio and should be asked for from any Pharma company for registration by any regulatory agency, be it a third world or the west. kind regards, Lakhvinder. Clinical Research Scientist Ranbaxy India lakhvinder@email.com -- To send a message to E-Drug, write to: e-drug@healthnet.org To subscribe or unsubscribe, write to: majordomo@healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@healthnet.org Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)