Special Symposiums

Impact of Generic Drugs on Health Care

As a forced consumer of generic drugs, I am always concerned about the bio-availability and the bio-equivalence of generic drugs. This question is becoming more and more important after we are bombarded with the news that India has the largest number of FDA approved pharmaceutical companies other than USA. A number of questions crop up in my mind. Who will monitor the BA/BE of the generic drugs manufactured in India? Will it be left to the Pharma companies in India to do their own monitoring of the standards? Will they be mandated to get a second validation done at some point before they hit the American market? US FDA has a well established generic drug review process in place (www.fda.gov/cder/handbook/anda.htm). One can voice their concerns to Timothy W. Ames at amest@acder.fda.gov

In addition to the problems related to QA issues there are concerns about how effective are these generic drugs? According to some experts, although it is lead to believe that all heparins are equal, some seem to be more equal than others. Heparins in clinical use differ considerably, depending upon the method of preparation, molecular weight distribution and pharmacodynamic properties. Currently available low molecular weight heparins (LMWHs) include, dalteparin (Pfizer) enoxaparin (Sanofi-Aventis) and tinzaparin (Pharmiom). At present no guidelines are available to address these issues related to clinical use of generic drugs. During the SASAT 2006 conference in Bangalore, we will address these issues and provide a platform to generate the much needed guidelines.

Control of Surgical Bleeding by topical applications

There is considerable interest in developing a suitable topical patch or a plug for controlling surgical bleeding or post procedure bleeding. Depending on the type of wound created by the procedure various types of topical applications may be needed for the control of bleeding. Several topical applications include thrombin as one of the components for initiating the contact activation of the coagulation process. There is considerable interest in the use of fibrinogen and fibrin based composition in these topical preparations. there are some preparations with collagen based formulations. One of the recent introductions into this market is a mechanism which uses shear force for activation of the coagulation pathway instead of using any pro-coagulants, substrates or agonists. During the SASAT 2006 conference in Bangalore, we will address these issues and provide a platform to generate additional information on this subject.

Drug Interactions and Development of Drug Resistance

Aspirin as a therapeutic drug has been in use for over one hundred years. Its use as an anti-platelet drug was recognized in the early 70's. For secondary prophylaxis of vascular disease, it is the most useful and cost-effective drug. A Large number of clinical trials using aspirin have concluded that aspirin at any given vascular risk, low to medium dose of aspirin (80 - 100mg), is as effective as any other drug of choice. However, in recent years, there are several studies in which aspirin resistances in patients with various vascular diseases have been demonstrated. Furthermore, some studies have suggested worst outcome in aspirin non-responders. Therefore, there is a great need to develop specific and rapid assays that could detect the prevalence of aspirin resistance in patient populations so those found to be non-responders might be provided an alternate treatment regimen. Similarly there are occasional reports about resistance to Clopidogrel. In view of these observations, during SASAT 2006 conference, we will provide a platform to discuss the issues related to drug interactions in general and address issues related to resistance to anti-platelet drugs such as aspirin and clopidogrel.