Table 3 Number, volume (in billion SUs), and market share of antibiotic FDC formulations marketed in India by approval and ban status, 2008–2020
2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FDCs | No. | 114 | 115 | 119 | 122 | 124 | 121 | 123 | 119 | 119 | 118 | 116 | 116 | 112 |
Vol | 3.7 | 4.0 | 4.2 | 4.5 | 4.8 | 5.3 | 5.5 | 5.9 | 5.6 | 5.3 | 5.0 | 4.9 | 4.5 | |
FDC formulations | No. | 574 | 598 | 634 | 646 | 611 | 599 | 578 | 531 | 526 | 508 | 486 | 421 | 395 |
Formal CDSCO Approval | No. | 86 | 93 | 100 | 107 | 108 | 113 | 111 | 109 | 106 | 106 | 103 | 96 | 94 |
15.0% | 15.6% | 15.8% | 16.6% | 17.7% | 18.9% | 19.2% | 20.5% | 20.2% | 20.9% | 21.2% | 22.8% | 23.8% | ||
Vol | 1.2 | 1.4 | 1.7 | 2.0 | 2.3 | 2.4 | 2.5 | 2.6 | 2.7 | 2.7 | 2.7 | 2.7 | 2.5 | |
32.0% | 35.2% | 40.9% | 45.1% | 47.5% | 45.1% | 46.1% | 44.7% | 48.8% | 52.2% | 53.3% | 54.1% | 55.3% | ||
Effective Approval (NOC) | No. | – | – | – | – | – | – | – | 16 | 20 | 22 | 20 | 20 | 23 |
– | – | – | – | – | – | – | 3.0% | 3.8% | 4.3% | 4.1% | 4.8% | 5.8% | ||
Vol | – | – | – | – | – | – | – | 0.5 | 0.6 | 0.5 | 0.5 | 0.5 | 0.5 | |
– | – | – | – | – | – | – | 8.0% | 10.1% | 9.8% | 9.4% | 9.5% | 10.6% | ||
Approved TOTAL | No. | 86 | 93 | 100 | 107 | 108 | 113 | 111 | 125 | 126 | 128 | 123 | 116 | 117 |
15.0% | 15.6% | 15.8% | 16.6% | 17.7% | 18.9% | 19.2% | 23.5% | 24.0% | 25.2% | 25.3% | 27.6% | 29.6% | ||
Vol | 1.2 | 1.4 | 1.7 | 2.0 | 2.3 | 2.4 | 2.5 | 3.1 | 3.3 | 3.3 | 3.1 | 3.1 | 3.0 | |
32.0% | 35.2% | 40.9% | 45.1% | 47.5% | 45.1% | 46.1% | 52.7% | 58.9% | 61.9% | 62.7% | 63.7% | 65.9% | ||
Banned | No. | 0 | 0 | 0 | 0 | 0 | – | – | – | 60 | 3 | 47 | 45 | 39 |
< 0.1% | < 0.1% | < 0.1% | < 0.1% | < 0.1% | – | – | – | 11.4% | 0.6% | 9.7% | 10.7% | 9.9% | ||
Vol | < 0.1 | < 0.1 | < 0.1 | < 0.1 | < 0.1 | – | – | – | 0.3 | < 0.1 | 0.2 | < 0.1 | < 0.1 | |
< 0.1% | < 0.1% | < 0.1% | < 0.1% | < 0.1% | – | – | – | 4.9% | 0.1% | 3.9% | 0.7% | 0.2% | ||
Unapproved | No. | 488 | 505 | 534 | 539 | 503 | 486 | 467 | 406 | 340 | 377 | 316 | 260 | 239 |
85.0% | 84.4% | 84.2% | 83.4% | 82.3% | 81.1% | 80.8% | 76.5% | 64.6% | 74.2% | 65.0% | 61.8% | 60.5% | ||
Vol | 2.3 | 2.4 | 2.4 | 2.3 | 2.4 | 2.3 | 2.3 | 1.8 | 1.3 | 1.3 | 1.0 | 0.8 | 0.7 | |
63.3% | 61.6% | 56.0% | 51.5% | 49.8% | 43.9% | 41.3% | 31.4% | 22.7% | 25.5% | 19.5% | 16.6% | 15.7% | ||
Banned and unapproved TOTAL | No. | 489 | 506 | 535 | 540 | 504 | 487 | 467 | 406 | 400 | 380 | 363 | 305 | 278 |
85.2% | 84.6% | 84.4% | 83.6% | 82.5% | 81.3% | 80.8% | 76.5% | 76.0% | 74.8% | 74.7% | 72.4% | 70.4% | ||
Vol | 2.3 | 2.4 | 2.4 | 2.3 | 2.4 | 2.3 | 2.3 | 1.8 | 1.5 | 1.3 | 1.2 | 0.9 | 0.7 | |
63.3% | 61.7% | 56.1% | 51.5% | 49.9% | 43.9% | 41.3% | 31.4% | 27.6% | 25.6% | 23.4% | 17.4% | 15.9% | ||
Undetermined | Vol | 0.2 | 0.1 | 0.1 | 0.2 | 0.1 | 0.6 | 0.7 | 0.9 | 0.8 | 0.7 | 0.7 | 0.9 | 0.8 |
4.7% | 3.2% | 3.1% | 3.4% | 2.6% | 11.0% | 12.6% | 15.9% | 13.6% | 12.5% | 13.9% | 19.0% | 18.2% | ||