India's psychotropic drug market flooded with unapproved FDCs: Study
https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF
A recent study has revealed that over 60 per cent of the fixed-dose combination (FDC) drugs used for treating mental health disorders in India are “unapproved” and lack proven therapeutic value, according to a report by The Print. This finding emerges amidst a significant crackdown on FDC drugs by the nation’s top drug regulatory body.
The study, which appeared in the Journal of Pharmaceutical Policy and Practice this month, involved researchers from the UK, India, and Qatar. It found that unapproved FDCs made up 60.3 per cent of psychotropic FDC sales in 2020, a slight decrease from 69.3 per cent in 2008 but still alarmingly high.
Click here to connect with us on WhatsApp
FDCs, which are a blend of two or more drugs in one pharmaceutical form such as a capsule, are often available in India without the approval of the Central Drugs Standard Control Organisation (CDSCO). Instead, these drugs are approved for manufacture by state authorities without adequate proof of safety and efficacy.
The study highlighted that "psychotropic FDCs are heavily marketed in India despite their exclusion from Indian clinical guidelines, minimal evidence supporting their therapeutic benefits, concerns about potential harm, and limited usage in other markets."
The persistence of unapproved FDC drugs in the market, making up a substantial portion of psychotropic FDC sales, raises concerns as these drugs have not undergone rigorous safety and efficacy evaluations, the researchers added.
