Pharma companies line up for clinical trials

Signalling a growing interest in new drug discovery research, some major Indian pharmaceutical firms had applied for conducting clinical trials on at least 12 new drugs in 2010. The most sought therapeutic area is cancer. The numbers are the highest ever in the history of domestic drug discovery initiatives triggered by companies such as Dr Reddy’s and Ranbaxy over a decade ago.

According to information provided by the health ministry, most of the 2010 applications pertain to Sun Pharma, Cadilla Healthcare and Piramal Life Sciences. The other firms who have applied for IND (Investigational New Drugs) approvals are Advinus, Issar, Life Care, Torrent and Wockhardt. A Sun Pharma spokesperson said the company has not given any update on its research programmes after May. The company is known to have obtained permission for clinical trials on drug candidates that belong to the anti-spastic, anti-allergic and anti-epileptic categories.

Among the pioneers, Ranbaxy had filed one IND application each in 2009 and 2008, while the last time Dr Reddy’s applied for conducting a clinical trial for new drug entity was in 2007. Of over 60 IND applications that have reached the health ministry so far (since 2000), 30 came during 2006-09. INDs are potential medicine candidates, which have never been tested elsewhere in the world.
 

TESTING GROUND
Firms	Categories	No. of IND applications	Firms	Categories	No. of IND
Cadila Health	Diabetes	2	Piramal Life	Anti-Cancer	applications
	Hyperlipidmia	2		Diabetes	4
	Anti-inflammatory	1		NSAID	2
	Anti-dyslipidemia	3			1
Sun	Antispastic	1	Dr Reddy’s	Anti-Cancer	3
	Antiallergic	1		Diabetes	1
	Antiepileptic	1		Anti-dyslipidemia	1
	Antihistamine	1		Cerebral Gliomas	1
Sun	Anti-Psoriasis	2	Torrent	Diabetic	1
	Anti-TB	1		Obesity	1
	Migrane	1		Anti-Arythmic	1

This makes it a unique category where Indian companies are probably the only applicants, since all clinical trials, initiated by foreign global multinational firms are categorised under “global clinical trials” as these medicines are simultaneously tested in other parts of the world.

According to a senior health ministry official, the current application status indicates a trend that Indian drug firms are inching towards the global drug discovery pattern in terms of selection of therapeutic categories they choose to work on.