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State drug regulators should ensure that medicines are sold only through prescriptions so that narcotic drugs are not diverted for trafficking or other illicit uses, Union Health Secretary Punya Salila Srivastav has said. Chairing a meeting with state drug regulators to address illicit use of psychotropic drugs under the Nasha Mukt Bharat Abhiyan and strengthen regulatory capacities of states and UTs on Monday, she said regulatory standards need to be strong to ensure that only quality and effective medicines circulate in the country. During the meeting, Srivastava urged state drug regulators to ensure that medicines are sold only through prescriptions so that narcotic drugs are not diverted for trafficking or other illicit uses. She also complimented Central Drugs Standard Control Organisation (CDSCO) and state drug regulators for completing risk-based inspections of 905 drug manufacturing and testing firms, resulting in 694 actions being taken so far. The meeting comes in the wa
Drug maker Cipla on Wednesday said it has received approval from the Central Drugs Standard Control Organisation for the distribution and marketing of Afrezza inhalation powder in India. Afrezza, a product created and manufactured by MannKind Corporation (MannKind) USA, is used to improve glycemic control in adult patients with diabetes mellitus. By bringing a game-changing, patient-centred solution to diabetes management in India, Cipla will make this drug accessible to all and empower millions to take control of their health with greater ease, the Mumbai-based company said in a statement. Afrezza is a rapid-acting insulin delivered through an inhaler compared to current insulins which are given as injections. Taken at the beginning of a meal, the medication dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream. Afrezza starts working as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals. T
The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combination in children below four years of age. Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has asked the drug regulators of all states and Union territories to instruct the manufacturers of fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml to insert warning that "FDC should not be used in children below 4 years of age" on label and package insert/promotional literature of the drug. In the letter, the DCGI stated that the FDC was declared as rational by the Professor Kokate Committee and based on its recommendation, this office had issued NOC for continued manufacturing and marketing of the FDC on July 17, 2015 under the 18-month policy decision. "Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants," he said. The matter was deliberated in the Subject Expert