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DRUG price regulator National Pharmaceutical Pricing Authority (NPPA) has started deciding the MRP for anti-asthma drug doxofylline in a move that has made leading brands such as Ranbaxy's Synasma and Dr Reddy's Laboratories' Doxobid 93% cheaper for consumers.
The pricing authority has fixed the price of doxofylline as it is a derivative of another price-controlled drug theophylline used to treat asthma, an NPPA official said. "Through our technical assessment, we have found that doxofylline is a derivative of a bulk drug theophylline, which is already under price control. Hence, as per the drug price control order (DPCO), we have fixed the price of doxofylline at Rs 5.74 for a strip of 10 tablets of 400 mg," said the official, who asked not to be named.

According to the pricing authority's guidelines, firms selling doxofylline will have to implement the new retail price by mid May. At present, Dr Reddy's Doxobid 400-mg costs Rs 78 for a strip of 10 tablets, and Ranbaxy's Synasma 400-mg is priced at Rs 75, the official said. With the new price of Rs 5.74 per strip, consumers will pay less than onetwelfth of that. An email query sent to Dr Reddy's and Ranbaxy remained unanswered. Other companies such as Glenmark Pharmaceuticals and Unichem are also selling the drug in India. The asthma-related drug market in India is estimated to be around Rs 500 crore.

Experts say doxofylline is scientifically inferior than theofylline and has not been approved in several countries, including the United States, because companies cannot prove non-inferiority.

"Since theophylline is under price control, companies launched doxofylline in India merely to circumvent price control. Doxofylline is available in just a couple of countries in the world," said CM Gulati, publisher of a leading medical journal. The cost of a strip of 10 tablets of theophyl line 400-mg is fixed at Rs 6.40, he added.

The move is significant because now companies manufacturing or marketing this antiasthma drug would not like to spend a lot of money to push it through doctors and chemists. "One important reason why doxofylline is more expensive than theofylline is that it allows companies to generate a high-profit margin," an industry analyst said.

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