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First India-developed drug approved

India’s drug regulator gives conditional marketing approval to Ranbaxy’s anti-malaria drug – potentially the first non-generic drug developed by an Indian company

Ranbaxy's new anti-malarial has won conditional approval from Indian regulatory authorities.

If the Central Drugs Standard Control Organisation (CDSCO) ratifies its decision it would make Ranbaxy's arterolane maleate and piperaquine phosphate combination the first non-generic drug to be brought to market by an Indian pharma company.

The country's pharma sector has traditionally been very strong in producing generic copies of branded drugs, with Ranbaxy and Dr Reddy's Laboratories among its leading companies, but single-handed development of new drugs has so far proved unsuccessful.

The approval of Ranbaxy's arterolane maleate and piperaquine phosphate is still dependent on CDSCO's inspection, and approval, of the Chinese plant that will produce the drug.

That facility has already been approved to supply Ranbaxy's clinical trial programme, but the Indian government is exercising additional caution.

"Since [the drug] will be widely used we want to check for our satisfaction," India's drug controller general Surinder Singh told the Economic Times.

The Indian newspaper also reported that the likely cost of the treatment is less than one third of the price of brands in the market sold by foreign drugmakers and Ranbaxy said it aims not only to reduce treatment costs but also to reduce the pill burden for patients.

The drug should be taken once a day for three days, compared with current treatment options for P. falciparum malaria, which can involve up to eight medicines a day over a three-day course.

As reported in PMGroup's Country Report: India, the pharmaceutical market in the India is expected to reach $55bn a year by 2020, up from $12.9bn in 2009.

1st November 2011

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