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Banned anti-diarrheal drug available for
another quarter
By Hina Kiyani
Islamabad—The Drugs Registration Board, Ministry of Health cancelled the
registration of anti-diarrheal drug "Kaolin Pectin" on March 4 2008, but
in the meantime has extended the consumption of its available
manufactured stocks till June 30, 2008, according to a statement issued
by TheNetwork for Consumer Protection in Pakistan.
The U.S. Food and Drug Administration (FDA) have banned the
manufacturing of all anti-diarrheal drugs containing Kaolin Pectin
because of lack of efficacy. Instead paregoric-containing medications
have been replaced by equally or more effective and safer agents for the
treatment of diarrhea.
Drugs Registration Board in its 211th meeting decided for withdrawal /
cancellation of drugs registration of all the formulations containing
"Kaolin Pectin" for lacking efficacy under Section 7 (11) of Drugs Act,
1976.
Dr. Talib Lashari Executive Coordinator TheNetwork for Consumer
Protection in Pakistan, appraised the decision by the Drugs Registration
Board for banning an ineffective drug prescribed for diarrhea, a common
disease amongst all ages. Meanwhile Dr. Talib Lashari has expressed
concern over the permission granted to marketing authorization holders
of the drugs containing Kaolin Pectin which permits consumption of the
available stocks, already manufactured, till 30th June, 2008. He
reasoned out that if Kaolin Pectin is prescribed then because of
inefficacy people can not get well, especially children of under-five
years of age, therefore continuity of this drug may further enhance the
prevalence of diarrhea.
Dr. Talib Lashari emphasized while quoting the Section 7 (12) of Drugs
Act, 1976 which defines that the provincial government shall take all
such steps as may be necessary to ensure compliance with the condition
subject to which a drug is registered and to prevent the manufacture or
sale of the drug if the registration of which has been cancelled or
stands suspended. Dr. Talib Lashari also advised doctors not to
prescribe this medicine to patients. |