Dextromethorphan Hydrobromide Hydrate

New Delhi: Under its monthly quality review drive, the Central Drugs Standard Control Organization ( CDSCO ) has identified 112 Not of Standard Quality (NSQ) drug samples along with a spurious sample of a cough syrup. Making the announcement, the Union Health Ministry in a note sated that, of the total 112 NSQ samples, Central Drugs Laboratories have identified 52, while the remaining 60 were flagged by State Drugs Testing Laboratories. The NSQ list of September includes several common medicines such as Paracetamol, Pantoprazole,, Multivitamin supplements and several other common drugs. Meanwhile, as per the CDSCO alert the drug sample flagged as spurious by the state drug testing laboratory in Chhattisgarh is of a dry cough syrup ‘Besto-Cof’ Several e-pharmacy platforms have listed the drug as a formulation of Phenylephrine, Chlorpheniramine Maleate and Dextromethorphan Hydrobromide marketed by ‘ BestoChem Formulations India Ltd. ’ “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and the same is a spurious drug.” the alert, suggests. According to CDSCO, the product is purported to be spurious, subject to outcome of an ongoing investigation into the matter. Under the Drugs and Cosmetic act of 1940, a drug is deemed as spurious if it is manufactured under a name which belongs to another drug and resembles in a manner likely to deceive consumers. The identification of a spurious cough syrup from the batches collected in September coincides with a tragic incident in Madhya Pradesh (an adjoining state to Chhattisgarh) where at least 24 children died after consuming a cough syrup brand Coldrif., later found found to contain 48.6 per cent Diethylene Glycol (DEG), a toxic solvent whose permissible limit in pharmacopeial formulations is only 0.1 percent. In October, two more brands—Respifresh TR and ReLife—were identified as contaminated with Diethylene Glycol (DEG) beyond the permissible limit; however, they were not linked to any of the reported casualties in MP. Following a official communication from the CDSCO, last week the World Health Organisation (WHO) had issued a global alert for three brands–Coldrif manufactured by Tamil Nadu-based Sresan Pharmaceuticals, Respifresh TR by Gujarat-based Rednex Pharmaceuticals and ReLife by Shape Pharma. Accordion to a PTI report the Union Health Ministry is also mulling to bring a new law replacing the Drugs and Cosmetics act of 1940 to arm the central body with more powers such as, “to take immediate action against manufacturers of fake or substandard medicines.” Meanwhile, the central regulator on its part has also undertaken several measures including mandatory testing of raw material used for producing formulations, online monitoring of high risk solvents along with conducting risk-based inspections at serval pharma clusters. By Online Bureau ,

New Delhi: Under its monthly quality review drive, the Central Drugs Standard Control Organization ( CDSCO ) has identified 112 Not of Standard Quality (NSQ) drug samples along with a spurious sample of a cough syrup. Making the announcement, the Union Health Ministry in a note sated that, of the total 112 NSQ samples, Central Drugs Laboratories have identified 52, while the remaining 60 were flagged by State Drugs Testing Laboratories. The NSQ list of September includes several common medicines such as Paracetamol, Pantoprazole,, Multivitamin supplements and several other common drugs. Meanwhile, as per the CDSCO alert the drug sample flagged as spurious by the state drug testing laboratory in Chhattisgarh is of a dry cough syrup ‘Besto-Cof’ Several e-pharmacy platforms have listed the drug as a formulation of Phenylephrine, Chlorpheniramine Maleate and Dextromethorphan Hydrobromide marketed by ‘ BestoChem Formulations India Ltd. ’ “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and the same is a spurious drug.” the alert, suggests. According to CDSCO, the product is purported to be spurious, subject to outcome of an ongoing investigation into the matter. Under the Drugs and Cosmetic act of 1940, a drug is deemed as spurious if it is manufactured under a name which belongs to another drug and resembles in a manner likely to deceive consumers. The identification of a spurious cough syrup from the batches collected in September coincides with a tragic incident in Madhya Pradesh (an adjoining state to Chhattisgarh) where at least 24 children died after consuming a cough syrup brand Coldrif., later found found to contain 48.6 per cent Diethylene Glycol (DEG), a toxic solvent whose permissible limit in pharmacopeial formulations is only 0.1 percent. In October, two more brands—Respifresh TR and ReLife—were identified as contaminated with Diethylene Glycol (DEG) beyond the permissible limit; however, they were not linked to any of the reported casualties in MP. Following a official communication from the CDSCO, last week the World Health Organisation (WHO) had issued a global alert for three brands–Coldrif manufactured by Tamil Nadu-based Sresan Pharmaceuticals, Respifresh TR by Gujarat-based Rednex Pharmaceuticals and ReLife by Shape Pharma. Accordion to a PTI report the Union Health Ministry is also mulling to bring a new law replacing the Drugs and Cosmetics act of 1940 to arm the central body with more powers such as, “to take immediate action against manufacturers of fake or substandard medicines.” Meanwhile, the central regulator on its part has also undertaken several measures including mandatory testing of raw material used for producing formulations, online monitoring of high risk solvents along with conducting risk-based inspections at serval pharma clusters. By Online Bureau ,