Regulatory Focus™ > News Articles > India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

Posted 01 November 2012 | By Alexander Gaffney, RAC

India's Central Drugs Standard Control Organisation (CDSCO) has released a new draft guideline on a new recall and rapid alert system for chemical and biological drug products, bringing it more closely into line with the recall system used by US regulators.

The intent of the rapid alert system is to place special emphasis on urgent recalls with the potential to seriously affect patients or the consuming entity (in the case of veterinary products, animals). These alerts should be transmitted with as little delay as possible, explained CDSCO.

The current problem, it said, is that while a recall system exists, it is not uniformly enforced throughout the pharmaceutical supply chain, particularly when it comes to timelines for action. "At present, auditing and accountability is not in place [for time lines]," wrote CDSCO.

The new recall guideline will apply to manufacturers, importers, stockists, distributors, retailers or any other licensed entity, and to both voluntary and mandatory recalls.

The recall system will use a "Class" system to categorize recalls: Class I recalls are the most serious, while Class II and Class III recalls represent sequentially less serious recall actions. The classification system and language associated with the recall's significance is nearly identical in wording to that of the US' recall system.

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, respectively.

CDSCO also proposed a "mock recall" system in which at least one batch of any product released for sale to "maximum distributors" should be recalled to, "Test the effectiveness of the arrangements of recall." This recall should be tested on the "longest distribution chain and whenever there is a change in distributor/marketing company," added CDSCO.

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