[e-drug] Standard Substandard Falsified - sharing experiences (4)

e-drug
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E-DRUG: Standard Substandard Falsified - sharing experiences (4)
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Colleagues

In addition to Christophe's excellent points I would like to add that on occasion a sovereign regulatory authority may cite a specific edition of the Ph Int, BP or USP in the approval document which locks the supplier to that standard. Unless the approval specifies the current edition, the specified edition is the rule of law.

Petersen's findings that over 80% of the products met stringent standards is encouraging; this is in marked contrast to the usual reports which tend to be more inflammatory.

Thomas Layloff, Ph.D.
Senior Quality Assurance Advisor
Supply Chain Management System
1616 Fort Myer Drive, 12th Floor
Arlington, VA 22209-3100
Direct Tel: +1.571.227.8608,
Email:tlayloff@pfscm.org,

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E-DRUG: Standard Substandard Falsified - sharing experiences (5)
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Thanks Christopher Luyckx for excellent points and the link provided.

The lack of technically competent people to evaluate and detect fraudulent certificates and test reports in drug dossiers submitted to the DRA plays a key role in the influx of substandard medicines in developing countries. The DRA is the gate keeper and unless the gate is firmly fixed and effective, the problem of substandard medicines coming in to the country will go on.

We are facing this problem on a weekly basis, which has resulted in shortages of essential medicines and wastage of millions of rupees.

Prof Rohini Fernandopulle MBBS, PhD
Clinical Pharmacologist, Senior Professor
General Sir John Kotelawala Defence University
Kandawala Estate
Ratmalana
Sri Lanka Telephone: +94112501217,+94772987707