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news.The Kerala state drug authority, Ernakulam's office of the Assistant Drugs Controller (ADC), has filed lawsuits against India-based Cadila Pharmaceuticals, Surya Pharmaceuticals and its Bangalore-based marketing company Micro Labs.
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The lawsuits were filed due to misbranding of Mokan and Micromox brands by the pharma firms violating Schedule P of the Drugs & Cosmetics Act.
Pharmabiz quoted Ernakulam ADC Revi Menon saying that the companies have printed dates of expiry for their products surpassing the actual period prescribed in the D &C Act.
"Cadila‘s amoxicillin dry syrup, Mokan, and the same drug in the brand name of Micromox manufactured by Surya Pharmaceuticals and marketed by Micro Labs have printed a expiry period of 24 months on the label," Menon said.
"As per schedule P of D&C Act, the maximum shelf life for dry syrup is 18 months and the expiry date should have been printed accordingly.
"But in the cases of both ‘Mokan’ and ‘Micromox’, the companies have mentioned 24 months usage with an additional period of 6 months, going beyond the prescribed periods and the potency of the dry syrup will usually lose after 18 months."
Ernakulam drug inspector Jayan Philip said that the punishment for violation of Schedule P is a jail term of three years and a fine of INR25,000 ($546m), quoted the website.