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On Saturday, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) suspended the membership of Maiden Pharmaceuticals, the manufacturing company flagged by WHO last week over the death of 66 children in the Gambia after using their cough syrups.
The company’s US arm is making a class II recall of two products namely amlodipine and olmesartan medoxomil tablets indicated for high blood pressure. 3,672 tablets are being recalled from the market because of deviations from the standard manufacturing process.
The GSK (GlaxoSmithKline) drug has been in use to vaccinate pregnant women since its approval in 2005 but the latest decision extended its use to the treatment of Pertussis, also known as whooping cough in young infants majorly under 2 months.
After the preliminary analysis of adverse drug reactions from the PvPI database, the IPC, which is the NCC (National Coordination Centre) for Pharmacovigilance Programme of India (PvPI), has raised concern over the drug safety of piroxicam, an NSAID, stating it is responsible for an adverse event called fixed drug eruption.
The Subject Expert Committee (SEC) of India’s drug regulatory body, in its recent meeting, recommended the grant of permission to Mylan Labs to import and market delamanid dispersible tablets of 25 mg strength for children suffering from pulmonary multi-drug resistant tuberculosis (MDR-TB).
The company’s Director spoke on Saturday that their company has been in the Pharma manufacturing business for over three decades and their products are not sold in the commercial market. Additionally, they have all the required export approvals for the products that have come under the scanner of drug authorities.
WHO announced that till date Maiden Pharmaceuticals have not provided guarantee to it on the safety and quality of these cough syrup products. Additionally, two health experts in India have suggested that India’s Ministry of Health including the DCGI and CDSCO should be answerable for the deaths in the Gambia.
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