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

Abstract

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. FDCs available in India were also screened against the National List of Essential Medicines India 2015 and the Orange Book Database of products approved by USFDA. Results: Of 110 available first- to fourth-line anti-tubercular FDCs, only 32 were approved. Of 20 antimalarial FDCs available, eight were approved. However, almost 95% of available antiretroviral FDCs and branded products were approved. The sales volume of all anti-tubercular drugs was 730 million units of which 71% were unapproved, amounting to 14.30 billion rupees in sales value (58%). Almost half of the sales value and volume of antimalarials was generated by unapproved products. About 1% of sales volume of antiretroviral FDCs came from unapproved formulations, accounting for 5% of sales value. Conclusion: A large proportion of FDC formulations available in India has never been approved by CDSCO, hence raising the doubts about their safety and efficacy. An opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.