India Draft recall guidelines prompt concern over implementation challenges

摘要

India's proposed first-time structured recall guidelines for drugs including biologicals and vaccines are seen as much overdue, but some experts say that implementation aspects may pose challenges given the large number of players across the chain in the industry.The draft guidelines, which include a recall classification along the lines of those of the US Food and Drug Administration, are applicable to all quality-defective product reports and to all reported incidents of safety and efficacy for drugs including vaccines and biologicals.The guidelines, which will cover manufacturers, importers, stockists, distributors and retailers and also suggest the need for "mock recall" drills, are currently open for comments.