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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

India: Stability Data Required

Nov 3, 2017, 09:39 AM
News Source Link:
http://www.cdsco.nic.in/writereaddata/Stability%20data.pdf
RegulatoryNewsDate:
Nov 3, 2017, 08:40 AM

In August, India’s Central Drugs Standard Control Organisation (CDSCO) notified all regional drug controllers that they must better enforce requirements for Indian manufacturers to submit quality data for nonpatent and proprietary medicines. CDSCO requires this data at the time of submission. Data should show that drug product is stable under storage conditions.

regulatory-news-regions:
  • Asia Pacific