Indian Regulators Finalize Recall System Requirements
Posted 03 December 2012 | By
Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and biological drugs, bringing the country much more closely in line with the recall standards of most established regulatory authorities.
The draft guideline, released in late October, was available for public comment for 15 days. A side-by-side analysis of the draft and final guidelines by Regulatory Focus shows that the final version contains only editorial tweaks-spelling, grammar, and minor clarifications-but no substantial changes.
The new final guideline, Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals and Vaccines)(PDF), became effective as of 23 November 2012 but was only released on CDSCO's website on 30 November.
The recall system envisioned by CDSCO would see India more closely approximating the recall system used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The class-based recall system uses three familial classes: Class I for serious issues, Class II for potentially serious issues, and Class III recalls for less serious recall actions.
A Class I recall will be required to be initiated within 72 hours after the receipt of information indicating the need for a recall. Within 24 hours of that determination, the sponsor will be required to communicate with affected stakeholders-including regulators-indicating the, "Severity of the defect, using the faster mode of communication," including email, telephone, fax and text message.
Class II and III recalls will be required to occur within 10 days and 30 days of the receipt of information, respectively.
CDSCO's guideline also establishes a "mock recall" system in which one batch of any marketed product must, at least once, be recalled from the longest point of distribution from the manufacturer.
The recall guideline will apply to all manufacturers, importers, drug stockists, distributors, retailers and licensed entities, the guideline says.