Food and Drug Administration Admits To Lacking Efficient Immediate Mechanisms

Mumbai, 30th December 2022: The Food and Drug Administration’s lack of an immediate mechanism for prompting a recall or not to use distributed stocks of a drug in the event of a severe reaction has been revealed. The administration admitted that the process of withdrawing or stopping this stock takes a few days.

At Saifee Hospital, Charni Road, a patient died of a severe reaction to the Orofer injection. Another patient had a similar reaction. But he did not lose his life. When a complaint was made to the Food and Drug Administration, samples from the hospital’s stock were sent for examination. Samples of the stock of the same medicine in Pune have also been sent for examination. The chemical analysis report has not yet been received. After that, Emcure Pharmaceuticals Company has been asked to immediately stop this stock. But this stock is distributed across the country. On this occasion, it became clear that the Food and Drug Administration does not have such an effective mechanism to stop it.

An official said, “We have written a letter ordering the company to stop the relevant stock. The company informs its wholesale supplier. The wholesale supplier informs the retailer and instructs him not to deliver the stock. This stock must be deposited with the administration. Till 24th November, the stock of 467 vials has accumulated with the administration. These statistics are meagre. Information has been sought about how much stock the company has provided to wholesale traders in the state. This means that it is clear that the administration does not have concrete information about this. The administration has no direct control over this entire system. Also, it is not possible to verify whether these instructions reach down through the company.”

When Food and Drug Administration Commissioner Abhimanyu Kale was asked about this, he admitted to the flaws in the process. If a drug turns out to be dangerous, it should be stopped immediately, and the entire stock returned to that administration. Kale also said that the movement will be done in this regard.