Despite Ranbaxy, approvals for all other players see a decent rise.
Despite the ongoing trouble India’s largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world’s largest drug market with added vigour.
Drug approvals given to Indian firms were 30 per cent of total generic medicine approvals given by the US Food and Drug Administration (FDA) during 2008, higher than the 26.5 per cent share in 2007, according to official data.
The trend is likely to continue, as Indian companies account for 35 per cent of all ANDA (Abbreviated New Drug Application) approvals given by the FDA in the first two months (till February 23) of 2009. ANDA is an application for a generic drug approval for an existing licensed medication or an approved drug.
| THE SWEET PILL | ||
| YEAR | TOTAL ANDAs APPROVED | INDIAN SHARE |
| 2007 | 471 | 125 |
| 2008 | 452 | 136 |
| 2009 (Jan-Feb 23) | 77 | 27 |
Except Ranbaxy, all leading players such as Dr Reddy’s, Wockhardt, Aurobindo and Sun sustained or improved their generic medicine approval tally in the US during this period.
One outcome of this trend is the FDA’s decision to open offices in India, which has encouraged Indian companies to hope for more improvement in their US presence. A Delhi office of the FDA opened on January 15 and will soon have senior technical experts in drugs, foods and medical devices. There will be seven FDA staff in Delhi and five in Mumbai by the year-end.
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Industry analysts feel the quantum of FDA approvals indicate that Ranbaxy’s woes — the US ban on two manufacturing facilities (one in Madhya Pradesh and the other in Himachal Pradesh) and import restriction on 30 medicines — are more of a company issue than a systemic problem for Indian generic manufacturers.
Sun Pharma, the most US-centric drug firm among the lot, got 30 ANDA approvals (against 20 the previous year) in 2008. This includes approvals by its US subsidiary, Caraco. Wockhardt got 18 approvals against 13 the previous year, and Dr Reddy’s tally went up from 13 to 14 (with another five approvals this year).
Against this, Ranbaxy, haunted by the US FDA through 2008, found its US drug approvals reduced from 13 in 2007 to just three in 2008.
KPMG says the US, despite intense competitive and pricing pressure, remains the largest generic market in the world. “With over $47 billion worth of drugs expected to go off-patent by 2011, the US represents a rich pipeline for generic manufacturers,” it says. The projected size of the US generic market in 2011 is $52.3 billion, 14 per cent of the total US drug market.