New Delhi: Unapproved formulations for mental illnesses accounted for over 60 per cent of psychotropic fixed dose combination (FDC) drug sales from 2008 to 2020, a recent study said. Fixed dose combinations (FDCs) contain two or more drugs in a single pharmaceutical form, such as a capsule.
According to a study published in the Journal of Pharmaceutical Policy and Practice in August, the proportion of overall psychotropic FDC sales accounted for by unapproved formulations has fluctuated over the years — increasing from 69.3 per cent in 2008 to 75.5 per cent in 2014 and then decreasing to 60.3 per cent in 2020.
“Unapproved FDCs continue to account for most psychotropic FDC sales, potentially putting the public at risk because their safety and efficacy have not been evaluated,” said the study by researchers from the UK, India and Qatar.
Unapproved formulations accounted for 49.7 per cent of antipsychotic FDC sales in 2008 and this increased to 57.7 per cent in 2020, it said.
Nearly all benzodiazepine or sedative FDC sales were for unapproved formulations across the study period.
Psychotropic FDCs are widely marketed in India despite their absence from Indian clinical guidelines, limited evidence of therapeutic benefit, concerns about potential harm and limited use in other markets, the study stated.
There were 35 psychotropic FDCs listed on PharmaTrac, an online database for the pharmaceutical industry, that had measurable sales volumes for at least one year between 2008 and 2020. Of the 35 FDCs, 30 had fully specified drug name data, it said.
Of the 30 FDCs, 13 were antipsychotics, 11 were antidepressants and six were benzodiazepine or sedatives. One FDC comprised four drugs, three comprised three drugs, and 26 comprised two drugs.
Of the 30 FDCs, there was evidence of regulatory approval for six in India, two in the US, one in the EU, and none in the UK.
Unapproved FDCs continued to account for over half of psychotropic FDC sales in 2020. The proportion of antipsychotic FDC sales accounted for by unapproved FDCs fluctuated markedly over the study period.
The study stressed that further regulatory measures are needed and the existing measures should be adequately enforced.
Firstly, unapproved FDCs should be withdrawn from the market. Secondly, the Central Drugs Standard Control Organisation (CDSCO) and state regulators should ensure that unapproved and banned FDCs are no longer manufactured. Third, the CDSCO should publish the evidence used to justify approvals, NOCs, and bans in full, the study said.
Fourth, the CDSCO should undertake regular audits and market surveillance to identify unapproved FDCs and intervene. Finally, further research should be carried out to understand the other factors that maintain the market for psychotropic FDCs and to identify other targets for intervention, such as changing public awareness and attitudes, it said.
A focus on regulatory measures without regard for context is likely to fail, it underlined.
This was a retrospective longitudinal study, combining pharmaceutical sales data and data from regulatory documents. The focus was on FDCs appearing in the sales data.
