USFDA approvals fail to enthuse Indian firms

In April, Mumbai-based pharmaceutical company Wockhardt announced it had received five marketing approvals for its generic medicines, versions of those that have gone off patents, from the US Food and Drug Administration (USFDA) in five weeks.

The company called it a reward for its efforts and a big fillip for it in the US market, the biggest in the world with a worth of $290 billion in 2006 and accounting for 45 per cent of global sales.

Yet, the announcement did not exactly create a sensation. If anything, such approvals have begun to be treated as par for the course.

All frontline Indian drug companies "" Ranbaxy, Dr Reddy's, Cipla, Sun Pharma, Lupin, Cadila "" are stacked with flasks full of USFDA approvals.

Over 40 per cent of the total drug master files "" applications seeking permission to market raw materials for making generic medicines "" and 33 per cent of abbreviated new drug applications "" seeking marketing approvals for medicines in their final form "" filed in the US are by Indian companies.

As a result, approvals have ceased to be objects to flaunt. In fact, they may soon become the cross that companies have to bear, unless they start showing results, as measured in sales and market share.

This is what is proving to be difficult. While Indian companies account for over 35 per cent of the drug marketing approvals issued by the US regulator, their share of the US market in terms of revenue is just 6 per cent.

The anomaly is caused by the overlap of marketing approvals; multiple Indian companies obtain approvals for the same product and end up battling one another through the age-old tool of price cuts, resulting in low revenues.

For instance, when Aurobindo Pharma received USFDA approval for generic drug "Zolpidem Tartrate" two weeks ago, 16 other companies, including Indian companies like Ranbaxy, Dr Reddy's, Wockhardt, and Sun Pharma (Caraco), already had approvals to market the same drug.

Similarly, USFDA's approval for "Lisinopril" to Wockhardt only means that the company is one among 16 competitors, including Indian companies Aurobindo, Lupin and Ranbaxy. The higher the number of competitors, the more the pricing pressures.

Satish Reddy, managing director and chief operating officer of Hyderabad-based Dr Reddy's Laboratories, said the "commoditisation" of the generic drug business in the US has harmed Indian interests.

"For all the big products going off patents in the next five years, we are already ready with generic versions. The day the patent lapses, there will be a generics rush from Indian players. This has killed the chances of growth in a highly profitable market."

With India having over 100 USFDA approved production facilities "" the largest number of such facilities outside the US "" the number of players capable of coming through US's scrutiny is sizeable.

The price war triggered by competing Indian companies in the US has already had its effect.

The growth of the US generic drug market has dipped from double digits to a single digit (8.3 per cent in 2006 against 17 per cent in 2000).