Sales and regulatory status of fixed dose combination psychotropic drugs in India: a retrospective longitudinal study

Abstract

Background: There is limited evidence to support use of fixed dose combination (FDC) drugs in the treatment of psychiatric disorders. This study aimed to examine the sales and regulatory status of psychotropic FDCs in India, in the context of two government regulatory initiatives.

Methods: Official documents were searched to establish an account of the initiatives and measures targeting psychotropic FDCs. This was integrated with private market data (2008 to 2020). Descriptive statistics were used to examine changes in FDC numbers/formulations and sales volumes in standard units (SU) over time.

Results: Psychotropic FDC sales volumes (percentage market share) increased from 0.8 billion SU (18.4%) in 2008 to 1.4 billion SU (20.1%) in 2020. The numbers (formulations) of FDCs also increased, from 28 (101) in 2008 to 33 (143) in 2020. Unapproved FDCs accounted for 69.3% of psychotropic FDC sales in 2008, decreasing slightly to 60.3% in 2020. Of 21 psychotropic FDCs considered under the regulatory initiatives, three went on to be banned, and two of these remained on the market in 2020.

Conclusions: 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.

Keywords: Fixed dose combination; India; pharmacoepidemiology; psychiatry; psychopharmacology; psychotropic.

Figure 1.

Key events relating to government initiatives to regulate unapproved FDCs. * The Gupta Committee report could not be located. DTAB = Drugs Technical Advisory Board, FDC = fixed dose combination, NOC = no objection certificate.

Figure 2.

Unapproved FDCs and FDC formulations on the market in 2020, by outcome under the first and second government initiatives and regulatory status. FDC = fixed dose combination, NOC = no objection certificate. Each box contains FDC and FDC formulation numbers, as well as the proportion of the psychotropic FDC market accounted for by those formulations. Note that figures for sales of unapproved formulations include those for which CDSCO have allowed NOCs. All proportions use total psychotropic FDC sales in 2020 as denominator. Six FDC formulations were considered under both initiatives; this is reflected in the sum of formulations ‘Evaluated by first initiative,’ ‘Evaluated by second initiative,’ and ‘Not evaluated’ ($7+41+42-6=84$) as well as the corresponding market share ($5.0\text{\%}+55.8\text{\%}+4.4\text{\%}-4.9\text{\%}=60.3\text{\%}$). The sum of the numbers of FDCs is much greater than 27 because of the overlap between initiatives and overlap between FDCs (in different formulations) ‘Evaluated by second initiative’ and ‘Not evaluated.’