Fixed dose combinations of anti-tubercular, antimalarial and antiretroviral medicines on the Indian market: critical analysis of ubiquity, sales and regulatory status.

Objective: To assess the proportion and sales of unapproved Fixed Dose Combinations (FDCs) of anti-tubercular, antimalarial and antiretroviral medicines available on the Indian market.

Methods: Available FDCs of anti-tubercular, antimalarial and antiretrovirals were screened against the Central Drugs Standard Control Organization (CDSCO) database of approved FDCs. The FDC sales information in the given categories was obtained from AIOCD AWACS PharmaTrac, a market database.