Last Updated on January 21, 2024 by The Health Master
The Gujarat Food and Drug Control Administration (FDCA) has cancelled 15 product permissions of 6 pharma companies based on risk-based inspections. Most of these companies are based out of Ahmedabad.
In the risk-based inspections, it was revealed that the products of some of the companies, producing widely prescribed gastrointestinal medicines and vitamins, were Not-of-Standard Quality (NSQ).
Products also include oral rehydration salt (ORS) and medicines like azithromycin for cold and amoxicillin for bacterial infections and also antimalarial medicines.
“Companies can now get their product permissions back only once they produce the stability data. These stability data studies have to be mandatorily done at testing laboratory.
This could entail the company to do research and reformulate the product again in the interest of patient safety,” informed Gujarat FDCA Commissioner Dr H G Koshia.
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