Regulation of psychotropic fixed dose combination drugs in India: a retrospective longitudinal study (Regulation of psychotropic FDCs in India)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The study aims to assess the impact of the efforts by the Indian government to regulate psychotropic fixed dose combination (FDC) drug sales.
• Data analysis plan:
  Descriptive statistics will be obtained to characterize sales trends over time. Where possible, interrupted time series analysis will be used to assess for changes in sales trends, for drugs banned by the Indian government.