India's psychotropic drug market flooded with unapproved FDCs: Study

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, the study found

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.

 

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.

The report quoted Ashna Mehta, a health economist and co-author of the study, as saying that the issue of unapproved FDCs in India is well-known. Despite various attempts by the regulator to eliminate them, these unapproved drugs continue to be available.

The team’s earlier research, published last year in the same journal, indicated that nearly 70 per cent of antibiotic fixed-dose combination drugs sold in India were either unapproved or banned.

Common drugs on Centre’s latest ban list

Earlier last week, the Centre imposed a ban on 156 additional fixed-dose combination (FDC) drugs, citing potential risks to human health. This marks the most significant crackdown on these drugs since 2018 when 344 such combinations were banned for being “irrational”.

FDC drugs, which typically contain a mix of two or more active pharmaceutical ingredients (APIs) in fixed proportions, were among those prohibited in a notification issued on August 12. ThePrint has obtained a copy of the notification.

The banned combinations included several antibiotics, as well as drugs for treating fever, allergies, colds, skin disorders, and pain, among others, that were widely available. 

Also prohibited were combinations of commonly used active pharmaceutical ingredients (API) with herbs like ginkgo biloba, as well as formulations mixing vitamins and enzymes.

The ban list also included multi-enzyme complexes with up to 12-15 enzymes and over 20 formulations containing naphazoline, a decongestant commonly found in eye drops.