A study published in the Journal of Pharmaceutical Policy and Practice has revealed that 60.3% of psychotropic fixed-dose combination (FDC) drugs sold in India in 2020 were unapproved and offered no proven benefits. The study analyzed private market data of psychotropic FDC drugs, including antipsychotics, antidepressants , and benzodiazepine /sedatives, from 2008 to 2020. It also found that 69.3% and 75.5% of psychotropic FDC drugs sold in 2008 and 2014 were unapproved, respectively. Alarmingly, these drugs were not endorsed by any Indian clinical guidelines.
In addition, the sale of these drugs was restricted in the USA, the European Union, and the UK. The study suggested that CDSCO and state drug regulators should intensify their efforts to prohibit the manufacturing and marketing of unapproved psychotropic FDC drugs. Did you find this article interesting? Share your views by…
