DTAB Seeks State Input on Unified Licensing Authority

India Pharma Outlook Team | Tuesday, 12 March 2024

 drug registration, drug regulatory mechanism, Central Drugs Standard, India Pharma Outlook

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The Drugs Technical Advisory Board (DTAB) of the Union Health Ministry has proposed that the Drugs Consultative Committee (DCC) collect opinions from various states on creating a single licensing and approval authority in India. During a recent hybrid meeting, the DTAB deliberated on this proposal and other pertinent issues, such as medication safety, self-medication, regulation of online pharmacies, and others.

The DTAB has recommended that the DCC seek the states' opinions during their meeting to establish a unified licensing and approving authority. The idea of a centralized drug regulatory mechanism has been discussed in the past, especially after reports of Indian-made cough syrups causing harm to children overseas.

In February 2024, the central government considered various options, including creating a centralized drug registration and quality-checking system to monitor drug quality issues across different manufacturing sites in the country. Additionally, industry leaders have proposed merging all state drug regulatory mechanisms with the CDSCO to implement a single quality standard nationwide.

The central government has also initiated efforts to digitize and streamline the approval processes under a single portal. The Central Drugs Standard Control Organisation (CDSCO) launched the National Single Window System (NSWS) earlier this year, and some approval processes have already shifted to the system.

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