FDA seizes cough syrups for violations

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The Food and Drug Administration (FDA), since the past week, has been seizing drugs, particularly codeine syrups or cough syrup bottles that bear labels of a brand name bigger than the generic name, as per the law. After crying foul in the face of a crackdown by the FDA for not employing pharmacists in their stores, chemists are now wary of selling cough syrups. Many city chemists have stopped storing codeine syrups, said representatives of chemists association.
“Since the past week, we have been seizing drugs where the manufacturers’ label, the brand name is displayed bigger than the generic name. This is a violation of the Drugs and Cosmetics Act,” said Kamlesh Shende, joint commissioner of FDA, Greater Mumbai.
As per rule 96 of the Drugs and Cosmetics Act, the proper name of the drug should be printed in a more visible manner than that of the trade name of the brand name.
Mr Shende added that owing to its popularity among addicts, codeine phosphate syrups bottles violate the rule of displaying the brand name bigger than the generic name.
“Many wholesalers have been given stop-sale notice for codeine syrups. There is now a shortage of this drug in the market. Owing to weather change, there are lot of people with cold and coughs. We do not want our clients to be upset and protest in front of our shops,” said Hukumraj Mehta, Mumbai zone president, Maharashtra State Druggists and Chemists Association. Mr Mehta added that their association is aware that the drug is addictive and that they do not encourage sale of the drug to addicts.
Owing to the ongoing seizures, shopkeepers have also stopped stocking codeine phosphate syrup bottles because they could unnecessarily incur losses, said Prasad Danave, general secretary, Retail and Dispensing Chemists Association.
In an ongoing campaign, the state FDA has been cracking down on chemists selling codeine phosphate syrups without a prescription and also without issuing a sales bill. Since 2011, the FDA has cancelled more than 60 licences of chemists violating the rules.

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