Pantoprazole Sodium 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 their routine quality review, Indian drug regulators in August have identified 94 select samples as Not of Standard Quality drugs (NSQ), while another three select batches have been flagged as ‘spurious’. Of the total 94 NSQ samples, 32 have been identified by Central Drugs Laboratories, while the remaining 62 samples were flagged by state drug testing laboratories . The three samples flagged as spurious include Diazepam Injection, Pan-40, Pan-D— all there were picked from Bihar and were identified by CDSCO labs. Notably some of the select samples flagged as spurious includes several therapies that feature in the top 10 brands in India (as per PharmaTrac) and are marketed by leading drugmakers in the country. “The identified samples were manufactured by an unauthorised manufacturer using a brand name owned by another company and the matter is under investigation“ a note from the Union Health Ministry stated. The firm’s replay (manufacturer) was not available under the CDSCO alert at the time of publishing the story. As per Drugs and Cosmetics Act , 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. Meanwhile, the NSQ list of August includes several common medicines such as Paracetamol, Pantoprazole, Cough syrups, Multivitamin supplements and several other common drugs. The identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However as per the Union Health Ministry, the failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market. By Online Bureau ,