DCGI introduces new traceability rules to address fake medicines issue

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DCGI introduces new traceability rules to address fake medicines issue - Business Standard

Quick Summary:

During the DCGI’s drugs consultative committee meeting in June, it was resolved to integrate good distribution practices into the Drugs and Cosmetic Rules, 1945, as a formal Schedule.

Records, including expiry dates and batch numbers, must be part of a secure distribution documentation system that enables traceability.

The Drugs & Cosmetics Act of 1940, along with the Drugs & Cosmetic Rules of 1945, sets out the conditions necessary for selling, stocking, exhibiting, or offering for sale or distribution of drugs throughout India.