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New Delhi: Indias drug regulator, Central Drugs Standard Control Organisation (CDSCO) is considering a proposal to treat all antibiotics as new drugs and, thereby, making centralised approval mandatory for launching any drug in this category, ThePrint has learnt...
In India, AMR has emerged as a massive public health challenge and a mega killer due to the rise of drug-resistant pathogens.Bacterial.
If the proposal comes through, it will mean that even the generic antibiotics and the drugs and formulations already granted marketing approval by the regulator (CDSCO) will have to get permission from it (CDSCO) for manufacturing the drug in the country, a senior CDSCO official told ThePrint..
The CDSCOs proposed initiative to mandate centralised permission for the launch of all antibiotics in India represents a significant step towards enhancing public health safety and ensuring the responsible use of these critical medications, Dr Prabhu Vinayagam, medical advisor, Orchid AMS, a division of Chennai-based Orchid Pharma, which specialises in antibiotics, told ThePrint...
The largely unrestricted and over-the-counter sales of most antibiotics, the manufacturing and marketing of many fixed-dose combinations (FDC) drugs with more than one active ingredient in specific proportions, and the overlap in regulatory powers between national and state-level agencies have influenced the availability, sales, and consumption of antibiotics in India...
