Mumbai: FDA Aims To Improve System In Cases Of Recalling A Drug

Mumbai, 27th November 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 has 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 testing. 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 inform and 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 an effective system to stop it.


An official said, “We have written a letter ordering the company to stop the relevant stocks. The company informed 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 November 24, the stock of 467 vials had 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 have reached down through the company. In this regard, drug controllers are informed, and instructions are given to take back the stock across the country.” But the official also admitted that the process was slow and dubious.


While all pharmaceutical companies are up-to-date in the online age, the Food and Drug Administration is not as well-equipped. The official also admitted that the administration has no control over the process of immediately stopping the supply and dispensing of a drug if it turns out to be dangerous. On this occasion, he expressed the need to change it. When asked about this, Commissioner of Food and Drug Administration Abhimanyu Kale admitted that there are errors in this 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 initiatives will be done in this regard.