19 Mar 2009
The Department of Health (DH) is investigating a case in which some pharmaceutical products supplied by a drug importer were not packed by licensed Good Manufacturing Practice (GMP) manufacturer.
The spokesman said today (March 19) that DH's investigation was made upon receiving a media enquiry concerning malpractice of Unipharm Trading Company which is a drug importer with no drug manufacturing licence.
He said the case involved suspected unlicensed packaging of Amitriptyline tablets (a drug for depression) by the company. The tablets were imported by the company from a licensed drug manufacturer in the United Kingdom.
The spokesman said pharmaceutical products imported by the company were required to be packed by local licensed GMP manufacturers before distributing to users and retail outlets.
However, investigations revealed that two batches comprising 4,049 bottles of 25 mg tablets (Batch No: AB725 and AB755) and one batch comprising 285 bottles of 10 mg tablets (Batch No: AA573) (each bottle contains 500 tablets)of Amitriptyline were packed by the importer which was not licensed to do packaging.
The spokesman said the drugs involved were distributed to public hospitals and public clinics, private hospitals, private doctors and a few pharmacies.
"Based on evidence at hand, there was no suggestion of safety or efficacy issue," the spokesman said.
DH has instructed the company to recall the products from public hospitals, public clinics, private hospitals, private doctors and pharmacies.
Doctors and pharmacists were also informed to stop supplying these products.
DH has also set up a hotline (2319-2905) for enquiries. The hotline will operate up to 10 pm today and from 9 am to 6 pm tomorrow.
The company has been instructed to recall the products concerned at shelf level and to set up a hotline (2499-1373) to answer clients' enquiries.
It was also alleged that the company had fabricated the expiry dates of four imported pharmaceutical products.
DH's on site inspection and investigations revealed that the expiry date shown on labels of three of the products, namely glibenclamide 5 mg, gliclazide 80mg and methyldopa 250 mg were supported by documentary evidence.
DH's investigation is ongoing.