Pharmabiz
 

CDSCO labs declare 53 samples as substandard in 6 months under drug alert system

Joseph Alexander, New DelhiThursday, May 30, 2013, 08:00 Hrs  [IST]

The different drug testing laboratories under the Central Drugs Standard Control Organisation (CDSCO) has reported so far 53 products as sub-standard in the last six months after the authorities launched the drug alert system to inform the public about those drugs, devices and cosmetics.

Allaying fears about the alleged circulation of spurious drugs in a bigger scale across the country, the tests have found almost all of them as substandard, mainly due to assay dissolution and assay description. And most of the cases reported were coming from small scale and lesser known companies.

On an average, the drug labs have been reporting around 10 cases as substandard every month out of hundreds of samples collected and sent by various zonal offices of CDSCO. From three cases in November, it went to seven in December as the momentum of reporting the cases picked up.

During the last four months from January this year, the momentum picked up and the drug testing laboratories reported a total of 43 cases. In January, the number of cases reported as substandard were 12 while it went down to 10 in February and 11 in March. In April, the CDSCO labs reported 10 cases, mostly from the Eastern region.

The alert system also has prompted the companies to recall batches of drugs found substandard, after placing them on the public domain for the information of the consumers.

Paracetamol tablets IP 500mg (batch BRJK002) manufactured by Bengal Chemicals and Pharmaceuticals Ltd, Rabby 20 (rabeprazole sodium tablets IP with batch number of ULT-3257) by Ultratech Pharmaceuticals based at Solan, Sodium Phosphate Enema BP (batch no EN25) from Godjay Laboratories of Ghaziabad, Afdcal 500 (calcium with vitamin D3 tablets) with batch number of TAF-12856 from Pro Laboratories of Haridwar, Isoniazid tablets IP (batch no T-1597) by Jackson Laboratories of Amritsar, KIMOL-KID Dispersible tablets (dispersible paracetamol tablets) with batch no AF-199 by Apex Formulation of Ahmedabad, MEGARAB-20 tablets (batch no S752887) from Scott-Edil Pharmacia of Himachal Pradesh, and GEENOR-400 tablets (batch no NR4-177) by Ghanshyam Pharmaceuticals of Assam were declared substandard by the laboratories.

 
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