E-drug: Generic quality (cont)
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Dear E-druggers
Generic quality is still a problem. The situation is much better in
Indonesia, since there is a regulation that all generic and branded generic
products should undergo comparative bioequivalence testing to prove their
quality. Our Department of Clinical Pharmacology of Gadjah Mada University
has conducted such study since 1984, and hundreds preparations have been
evaluated. From the experience so far, generic products showed a good
quality as compared to their comparators. The poor bioavailability is more
often found amongst branded generic products.
The problem raised when producers substitute the raw materials. There are
evidences that the oral absorption of the new material was inequivalent to
the one used when they underwent bioavailabilty testing. This leads to the
situation that bioavailability testing upon registration is not sufficient.
There must be a mechanism that substitution of raw materials (e.g., due to
different source or supplier) should be monitored, and bioavailability
testing should be re-done as necessary.
Dr. Sri Suryawati
Head, Department of Clinical Pharmacology
Faculty of Medicine, Gadjah Mada University
Yogyakarta 55281, Indonesia
Phone: 62 - 274 - 563 596, fax: 62 - 274 - 543711
suryawati@yogya.wasantara.net.id
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