Recall of iron supplement by Maharashtra FDA remains only on paper

Mumbai: Eight days after the state Food and Drug Administration (FDA) recalled a batch of the iron supplement infection Orofer FCM over safety concerns, not a single vial has returned to the manufacturer or the distributors.

This has prompted the drug regulatory body to take a fresh look at the entire drug recall mechanism, which appears to be at the mercy of WhatsApp groups created by chemists.

On November 17, the FDA issued an order asking Emcure to recall its product Orofer's (batch no. ELF8BB2001) following the death of a 55-year-old man at Saifee Hospital due to a suspected adverse drug reaction.

While it is still under investigation if there was a correlation between the drug and the man suffering an anaphylactic shock, the FDA Pune, in a rare move, issued an immediatere call notice asking drug controllers across India to stop using the medicine. Typically, such a notice is given after a laboratory test has found the samples “not to be of standard quality. ”

FDA commissioner Abhimanyu Kale told TOI that the department was discussing overhauling the drug recall systems when the Saifee incident occurred. “After the recall notice, we h ave been waiting to see how soon the unused vials will return to the manufacturer or the distributor. However, it has been seven days, and not one vial has come back,” he said.

Kale added that the department plans to propose software that could work as a platform to communicate with 10,000 distributors and 70,000-odd chemists on real-time. FDA, in its investigation, foundthat the batch contained 37,000 vials manufactured in May 2022 and distributed to several states.

FDA found that Saifee had procured the medicine from a Mumbai-based supplier, who bought it from a Pune agency that purchased it from an Aurangabad distributor who had bought the injection from a Delhi company. “With such a complex chain, nobody can be sure if the r ecall notice would reach the last supplier,” the commissioner said. Interestingly, Emcure has recently registered a complaint about its drug's adulteration.

Prasad Danave, preside nt of the Retailers and Distributors Chemist Association, said that chemists are part of multiple WhatsApp groups where recall orders are promptly distributed. However, no government de vice exists to inform everyone and ensure drugs are returned.