Additional file 1 of Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics

Additional file 1: Table A1. Systemic antibiotic FDC formulations permitted de facto approval outside the statutory regime (No Objection Certificate) for continued manufacturing and marketing under 18 month policy decision. Table A2. Systemic antibiotic FDCs banned and restricted in use in India, 2016-2019. Table A3. Systemic antibiotic FDCs marketed in India, 2008-2020. Table A4. FDC formulations banned by Ministry of Health and Family Welfare and still being sold in 2020. Table A5. FDC formulations with neither a record of formal approval from CDSCO nor de facto approval outside the statutory regime (No Objection Certificate) still being sold in 2020. Table A6. NLEM formulations of systemic antibiotic FDCs marketed in 2008-2020, by approval status. Table A7. Number, volume and market share of systemic antibiotic FDC formulations marketed in India by NLEM and approval status; 2008-2020. Table A8. Systemic antibiotic FDC formulations marketed in India for 10 and more years.