Bico-Z Syrup--produced by SR Drug Laboratories at Satungal, Kathmandu--contained crystalline deposits, which is against Department of Drug Administration (DDA) guidelines. DDA and manufacturers both conceded the defect in the syrup and claim that the defective batches have already been recalled. [break]
But the syrup is still being sold at many outlets outside Kathmandu. Republica has obtained a bottle of the syrup from the market.
“We don´t have the human resources to check whether all the products have been withdrawn from the market and have to hope that the company does so honestly,” said Pharmacy Officer Padam Prasad Poudel at the DDA Inspection Department in Kathmandu. The company claims to have withdrawn the product and the sample that Republica got hold of may be one of a very few not returned by chemists despite being told to do so.
Head of Pharmacy Department at Kathmandu University Dr Panna Thapa said the defect in Bico-Z Syrup may not be alarming. But he added, “If the company says a product is being recalled, it should be recalled. It´s an ethical question”.
Dr Thapa said in other countries defective products are recalled totally, and a detailed report on the number of defective units in existence and units recalled along with evidence of recalled units being destroyed are presented to regulatory bodies. But DDA has no record of the Bico-Z recalled.
There was a similar problem with the product around four years back. “The defect was first noticed four years back. The company said the problem was due to discrepancy in pH level and we gave permission for production after they said the problem was fixed,” Pharmacy Officer Poudel said.
But the problem resurfaced around a year back and the company said this time it was due to higher concentration of zinc sulphate. “We still don´t know the exact nature of the problem but our fresh products with a lower concentration of zinc sulphate have not shown the same problem so far,” senior representative of the manufacturing company Amit Agrawal said.
Dr Thapa said DDA and the company should have found the cause when the problem first surfaced. But Poudel conceded that DDA can´t conduct large scale tests due to its limitations and depends on tests by manufacturers.
Dr Thapa said the problem of physical instability is greater in syrups than in tablets and capsules. A DDA source said at least four Nepali products, all vitamin syrups, have failed during shelf life but did not elaborate for fear of being identified. “The problem with vitamin syrups may not be serious. But many life-saving drugs are sold in syrup form for use by children and the elderly,” Dr Thapa suggested. DDA´s limitations leave room to doubt the quality of other drugs, even life-saving ones, pharmacists fear.
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