Drug marketed to cure or kill?

Foreign particle, circled, is seen in a 500mg ampoule of Amibac intravenous injection.Photo: STAR

A black foreign particle was found in an ampoule of Amibac 500mg injection manufactured by Popular Pharmaceuticals Ltd and widely used for short-term treatment of serious infections.
Doctors prescribe the intravenous injection with generic name Amikacin to treat infections of the respiratory tract, bones, joints and skin, soft tissue infection and recurrent urinary tract infection.
Sufia Khatun, 59, a patient with respiratory tract infection, was prescribed the drug by Dr Rashidul Hasan of Popular Consultation Centre-2 and one of her relatives bought the antibiotic from the adjacent Specialist Medicine House.
The ampoule of batch No 4 bears an expiry date of August 2010 and the monogram of Popular Pharmaceuticals Ltd.
When contacted over telephone, Dr Pinaki Bhattacharya, chief operating officer of Popular Pharmaceuticals, said he just heard about the matter but did not see the ampoule in question himself, so he does not know if it was their product.
"If it is our product, I have to say it was a procedural mistake," Dr Bhattacharya said.
"From what I have heard about the size of the particle [found inside the ampoule] I can say it will not pass through the syringe needle and there is no possibility of its entering the vein of the patient," he added.
Normally, ampoules are marketed after a manually conducted visual inspection. Popular Pharmaceuticals manufactures 4 lakh ampoules of medicines a month and has so far manufactured approximately 1.5 crore ampoules, said Dr Bhattacharya.
Although existence of any foreign body inside an ampoule is not expected, one could be defective among the 1.5 crore ampoules, he said, adding that if the inspection were automated, one in every five million ampoules could be defective.
No company can guarantee that there would not be a single ampoule among the 1.5 crore without defects, he said.