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CDSCO launches Drug Alert system, issues alert on 3 drugs after testing by Central lab

Joseph Alexander, New DelhiMonday, December 31, 2012, 08:00 Hrs  [IST]

Introducing a Drug Alert system, meant to inform the public about the drugs, devices and cosmetics found substandard or spurious, the Central Drugs Standard Control Organisation (CDSCO) has published the names of three products which were not of standard quality during the month of November.

Central Drugs Testing Laboratory, Chennai has found these drugs as substandard and informed the CDSCO which has now published the details as part of Drug Alert.

Ranitin-152 tablets (batch no CD 981025), manufactured by Torrent Pharmaceuticals Ltd, Baddi in Himachal Pradesh, was among the three drugs listed as substandard. The product, with March 2011 as date of manufacturing and expiry date of February 2015, was sent for testing by the CDSCO, South Zone in Chennai.

Hobby Handwash Spring Freshers (batch no 2418), manufactured by Hobi Kozmetik AS and made in Turkey, was collected by CDSCO unit at the Indira Gandhi International Airport in Delhi and sent to the Chennai lab. The product, manufactured in May 2012 and carrying expiry date of May 2015 was also declared substandard in the testing.

The central lab also found as substandard Kohinoor Pink Pleasure condoms (batch no Px2054), manufactured by TTK LIG Limited, Pallavaram, Chennai. The pack, carrying expiry date of March 2015, was collected and sent for testing by ADC at the Chennai Port.

The Drugs Controller of General of India (DCGI) earlier this month had directed the drug testing laboratories under the CDSCO to send details of drugs which have been found to be not of standard quality, spurious, adulterated or misbranded to the CDSCO headquarters on a regular basis.

“In order to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics in India, it has been decided that the CDSCO is required to be informed about the quality defect in the medicinal products which require recall or restriction on supply. Where a product is considered to be a risk to public health, the marketing authorization holder will withdraw the affected product from use and the CDSCO as well as concerned State drug regulatory authority are required to be informed about such products so that suitable drug alert be issued for the information of the public,” the notice said.

 
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