Indian pharma companies are gearing up to strengthen the effective corrective and preventive action practices to stall drug recall instances. The key objective is to sustain high quality processes and remain constantly adhered to cGMP requirements.
Going by the recent trends in drug recalls by the USFDA, Indian pharma companies need to strengthen systems for corrective actions. It would prevent future occurrences in drug product recalls, said Narendira Kumar, head, quality assurance, Orchid Healthcare.
The pharma companies will need to explain the corrective actions planned or underway that will prevent the occurrence of a similar problem to the regulatory authority, he added.
In a presentation on “Recent Trends in Drug Product Recall: Overview”, Narendira pointed out that companies will need to prove the reported deficiencies in quality, efficacy or safety are rectified.
Recalls can be categorized under voluntary and statutory. Under voluntary recalls instances include drug batches found not complying for registered specification, or viewed to be defective during market complaint investigation or failing tests because of contamination, mix-up, unusual observation in retain sample and safety risk. Statutory recalls require responding to the direction of the drug regulatory authorities.
There are three types of recall. Class I recall is a situation where there is a reasonable probability that the use of or exposure to a violated product will cause serious adverse health consequences or fatality.
Class II recall is an exposure to an unapproved product which could cause temporary or medically reversible adverse health consequences. Class III recall is related to unapproved products which are not likely to cause adverse health consequences, he explained.
According USFDA enforcement reports, total number of recalls posted upto December 10, 2015 are 2003. Out of these 105 were under Class 1, 1771 of Class II and 127 in Class III. These include contamination where benzophenone leached from the product label varnish. A drug was recalled due to an elevated level of a residual solvent impurity in the active pharmaceutical ingredient (API) that exceeded the Threshold of Toxicological Concern (TTC). A product was contaminated with penicillin and foreign substances during manufacturing process.
Recalls related to the presence of particulate matter, had a human hair floating in IV solution. Products were also recalled due to presence of a metal besides finding free-floating and embedded iron oxide particles.
The global regulatory authority USFDA mandates that all pharma manufacturers with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) need to submit ‘Field Alert Reports (FAR)’ within 3 days of a problem being identified. It could be associated with any incident related to the product or its labeling to be mistaken for or applied to another drug, bacterial contamination, or reporting a significant chemical, physical, or other change. It could also be deterioration in the distributed drug product, failure of distributed batches meeting the specifications established in its application, said Narendira.