Around 2 million patients use doxofylline and its formulations for the treatment of asthma and chronic bronchitis. Significantly, neither theophylline nor doxyfylline is a controlled drug at present under the DPCO 2013.
The total domestic market for doxofylline stood at R500 crore in 2009 and top companies which manufacture its formulations include Ranbaxy, Macleods, Cipla, Wockhardt, Unichem and Lupin.
The apex court upheld the government's stand that the prices of doxofylline formulations were fixed in the interest of the consumer.
Drug manufacturers Swiss Garnier and Mars Therapeutics and Chemicals had challenged the notifications saying that doxofylline was not a bulk drug within the meaning of Para 2(a) of the DPCO 1995; that it was not a derivation of 'theophylline' as projected by the NPPA and that in any event without fixing the price of the bulk drug doxofylline, the prices of the formulations could not be fixed. It said Doxofylline is deemed to be a bulk drug within the meaning of para 2(a) conforming to pharmacopoeial and other standards specified in the Second Schedule to the Drugs and Cosmetics Act.