Karnataka drugs control dept to monitor Crocin Advance recall & Schedule H1 adherence

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Karnataka drugs control department has already commenced a drive to monitor recall of entire stocks of Crocin Advance from all chemists and druggist outlets in the state. The department is also conducting checks of outlets.

“We had issued stop production orders to the GlaxoSmithKline (GSK) in mid March 2014. The order was an oral communication and the company immediately came back to state drugs control department stating that it has gone on to revise the price of the drug which would be made available at Rs.14.84 for a strip of 15 tablets. However we have ensured that our team of enforcement officers are on the alert to check on this”, Raghurama Bhandary, drugs control government of Karnataka told Pharmabiz.

The drug is produced at the facility of Remedix Pharma located in the Peenya Industrial Area in Bengaluru which is GSK’s contract manufacturing unit, he added.

GSK is now making efforts to recall Crocin Advance which would be in the market with new price label of Rs.14.84, he added.

Coming to the Schedule H1 which was enforced from March 1, 2014, the Karnataka drugs controller has convened a meeting to ask all the chemists and druggists in the state to comply with the new order. He pressed upon the need to maintain separate register and bill books for the sale of drugs coming under Schedule H1 which includes antibiotics and psychotropic drugs.

“Our enforcement team will conduct regular and surprise checks to clamp down the violators of this new Schedule H1,” noted Bhandary.

The chemists and druggists will have no other option but maintain dedicated records to keep track of the sales of the drugs coming under the Schedule H1 category, said the Karnataka Drugs Controller.

Source: PharmaBiz


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