The prices of asthma drug doxofylline will come down drastically in the coming days as the Supreme Court has upheld the national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA)'s plea that doxofylline is a derivative of theophylline and it is well within the law to restrict its price under the Drug Pricing Control Order (DPCO), 1995.

Setting aside the Delhi High Court's earlier judgments on May 19, 2010 and March 15, 2011, which had held that the NPPA had no power to regulate the prices of doxofylline, the Supreme Court bench of Justices G S Singhvi and S J Mukhopadhaya held that “Doxofylline is derivative of theophylline, a bulk drug, and Doxofylline in any formulation comes within the definition of scheduled formulation, we hold that it is well within the jurisdiction of the Government to fix the ceiling price of doxofylline formulation under para 9 or para 11 of DPCO, 1995”.

Earlier in 2008, with the sole purpose of maximising profit, some companies had replaced the less profitable price controlled drug theophylline with doxofylline formulations on the plea that doxofylline is a distinct drug with better efficacy than theophylline. But there were no scientific basis to prove this argument as experts in the field opined that doxofylline was being offered as a better alternative to theophylline without any scientific basis and with the sole purpose of maximising profits.

While theophylline costs Rs.3 per strip of 10 tablets, doxofylline is sold by companies under different brands at a high price ranging from Rs.80 to Rs.110 per strip.

When the companies started switching over to doxofylline hoodwinking the drug price regulator, it came out with notifications on April 30, 2009, and November 17, 2009, bringing doxofylline formulations under the price control regime on the plea that doxofylline is a derivative of theophylline.

But two pharma companies, Swiss Garnier Life Sciences and Mars Therapeutics and Chemicals, challenged the NPPA notification in the Delhi high court and pleaded that doxofylline had no connection with theophylline.

With this judgment, the price of doxofylline will now fall drastically to a level more or less on a par with the price of theophylline, and the companies also have to pay a huge penalty on the drug, said Manoj Tongra, a legal expert and a drugs control officer in Rajasthan.

Doxofylline is a Rs.61-crore drug and major companies in this category include Ranbaxy (Synasma), Zydus Cadila (Doxolin, Macleods (Doxoril) Dr Reddy's (Doxobid), Lupin (Doxiflo), Glenmark (Doxovent) and Mankind (Ventidox).