The proposals – which were detailed in a document last month – are applicable to defective drug including vaccines biologics according to the Central Drugs Standard Control Organisations (CDSCO).
The aim is to establish action timelines based on the potential threat a defective pharmaceutical product poses to patients, which is determined using a three level classification system.
Class I recalls - which involve drugs where there is reasonable probability that a defective product will cause serious adverse health consequences or death - have up to be initiated within 72 hours, while for a class II a maximum of 10 days is allowed.
Class III recalls – which are intended for drugs that are deemed to pose a low or negligible risk – have to be started by the manufacturer in question within 30 days.
The plans– industry feedback on which is currently being collated and assessed by the CDSCO - also include a suggestion that pharmaceutical manufacturers, wholesalers and distributors undertake ‘mock recalls’ to test the efficacy of the procedures they have in place.
“During mock recall traceability shall be performed for at least, one of the raw material used in the batches identified for mock recall. Mock Recall shall be performed at least once for the longest distribution chain and whenever there is a change in distributor marketing company.”
Criticism
The publication of the recall guidance comes just a few months after the CDSCO was criticised for its oversight of mandatory safety reporting for drugs in a report by India’s Parliamentary Standing Committee on Health and Family Welfare.
Recalls were one of a number of subjects touched on by the committee with the primary concern being that when a defective product is identified "There is no effective method of recalling unsold stocks lying in the distribution network. This cannot be allowed to go on."