Pharmabiz
 

CDSCO to start issuing Drug Alerts based on test results of its labs on first week of every month

Joseph Alexander, New DelhiMonday, December 17, 2012, 08:00 Hrs  [IST]

With a view to further streamlining the drugs sector and step up quality, the Central Drugs Standard Control Organisation (CDSCO) will start issuing `drug alert’ from first week of every month to inform the public about the drugs, medical devices or cosmetics which were found substandard or spurious by its testing laboratories.

The Drugs Controller of General of India has 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.

The information will be uploaded for the public notice under a column `Drug Alert’ on the website of the CDSCO. Instruction was also given to upload them in the first week of every month, according to a notice by the DCGI.

“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.

Some of the States like Gujarat are already issuing alerts on drugs which are of not standard quality through SMS and other means in their respective states, it said.

“In order to ensure safety of the patients from the drugs of doubtful quality, it is imperative that the drugs which are not of standard quality, spurious, adulterated or misbranded, as declared by the drug testing laboratories, be put on website for immediate stoppage of such medicine from reaching to the patients,” the notice said.

 
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