Manufacturers to furnish stability data of non-patent and proprietary drugs, directs DCGI

Manufacturers to furnish stability data of non-patent and proprietary drugs, directs DCGI

August 28, 2017 Industry Specific 0

With an aim to ensure the quality of drugs, the Drugs Controller General of India (“DCGI”) has instructed state drug controllers to mandate manufacturers under their jurisdiction to submit the stability data of non-patent and proprietary medicines.

Highlighting the importance of the stability of a drug as a criterion to ensure quality, safety and efficacy of drugs, the DCGI has stated that manufacturers must furnish their stability data at the time of applying for permission to manufacture.

Source: Central Drugs Standard Control Organization

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