The state owned Andhra Pradesh Health Medical Housing Infrastructure Development Corporation has been caught distributing recalled batch of Clanoxy 375 mg tablet, an amoxicillin preparation, manufactured by the Mumbai-based Galpha Laboratories Ltd, through primary health centres.
The drug control officials seized 1100 numbers of Clanoxy 375 mg tablets with batch number COT 7031 IB distributed by the central drug store - APHMHIDC - through a Kanithi primary healthcare centre at Visakhapatnam, this month. The state drugs control administration (DCA) had recalled the batch in November 2008 as the drug does not meet the label claim in the analysis made at the Drugs Control Laboratory in Hyderabad, according to sources from the regulatory body.
The DCA may seek the concerned authorities to initiate action against the officials in the corporation and to review the drug recall mechanism of the central drug store in the backdrop of the issue, it is learnt.
A report submitted by the assistant director of the DCA, Visakhapatnam, on the incident raised concerns on the drug recall mechanism of APHMHIDC. The report explains that the distribution body has supplied 5000 Clanoxy tablets from the said batch to the primary health centre in which almost 3900 were already dispensed to patients.
"In the end of November 2008, the DCA has asked the manufacturer to recall the batch as the active ingredient in the tablets was not up to the quantity mentioned in the label. The presence of the said batch in primary health centre even after four months of recall shows sheer negligence from the part of the state-owned central drug store," said Ravi Uday Bhaskar, assistant director of the DCA, Visakhapatnam, who was assigned by the director general of the regulatory body to submit report.
The report opined that the recall mechanism in APHMHIDC at Hyderabad may not be functioning properly, the director general of drugs control administration has to take the issue with the APHMHIDC to see that this kind of incidents may not occur in future. The authority is further investigating the role of manufacturer - Galpha Laboratories - in not acting effectively even after the directions of the DCA to withdraw the batch from the market.
The said batch has only 126 mg of amoxicillin as against the label claim of 250 mg and 98 mg of clavulanic acid instead of 125 mg, he said. The product label claims that each film coated Clanoxy 375 mg tablet should contain amoxicillin trihydrate IP equivalent to amoxycillin 250 mg and clavulanate potassium USP equivalent to clavulanic acid 125 mg.
The officials also said that six batches of the same product has been failed in the sample tests conducted in the state drug testing laboratory. In August 2008, the assistant director, DCA, Visakhapatnam informed the public that Clanoxy 375 tablets (batch no. COT90281B) and Clanoxy 500 tablets (batch no. COMT-70101B), manufactured by the company at its facility in Himachal Pradesh were found to be not of standard quality.