Ranbaxy is set to become the first home-grown company to get a new drug to market
Ranbaxy is set to become the first home-grown company to get a new drug to market.
Ranbaxy's R&D lab at Gurgaon
It was India's largest pharmaceutical company when it was acquired by Japanese pharma major Daiichi Sankyo in 2008. Three years later, Ranbaxy Laboratories stands on the verge of also becoming the first home-grown company to successfully develop and launch a new drug, having obtained conditional market approval from the Drug Controller General of India, or DCGI, for its new anti-malaria combination, Arterolane maleate with Piperaquine phosphate.
While Ranbaxy has so far refused to comment, Malvinder Mohan Singh, Group Executive Chairman, Fortis Healthcare, who sold Ranbaxy to Daiichi, and was at the helm when this drug was being developed, was delighted. "It is absolutely fantastic. It is a new cure for malaria and is going to be the first NCE out of India that is actually developed and worked upon by an Indian company," he told BT. (NCE stands for new chemical entity.)
The drug is expected to revolutionise the treatment of Plasmodium falciparum malaria, a virulent form of the disease, which claims nearly one million lives a year, mostly in Africa. "Malaria is endemic in many countries, including India, and any breakthrough will provide succour to millions around the world," says Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India.
Global pharma major Roche had handed this project to Ranbaxy Laboratories in May 2003 under a project called the Medicines for Malaria Venture. But even if Ranbaxy did not initiate work on the drug, analysts maintain its achievement in developing it and bringing it to market is a landmark. Around 80 per cent of new drugs are brought to market by the big global majors, even though only 35 per cent of such drugs have been developed by them from the earliest stage. Smaller companies engaged in research often find going the full course up to the market beyond their means and end up outlicensing their NCEs to big pharmas. That a relatively modest company like Ranbaxy has been able to bring a drug to market is creditable.
"This development is significant for three reasons," says Ajit Mahadevan, Partner, Life Sciences, Ernst & Young. "First, the therapy area (malaria) is a focus area for emerging markets and India. Second, developments like these strengthen the credentials of Indian research and open up scope for more funding for it. Finally the cost of development of a drug will be lower in India than abroad,"
Will the drug transform Ranbaxy's fortunes? Analysts feel that, since the drug cannot be priced too high, it may not boost revenues excessively, though it may give the company decent returns.
While Ranbaxy has so far refused to comment, Malvinder Mohan Singh, Group Executive Chairman, Fortis Healthcare, who sold Ranbaxy to Daiichi, and was at the helm when this drug was being developed, was delighted. "It is absolutely fantastic. It is a new cure for malaria and is going to be the first NCE out of India that is actually developed and worked upon by an Indian company," he told BT. (NCE stands for new chemical entity.)
The drug is expected to revolutionise the treatment of Plasmodium falciparum malaria, a virulent form of the disease, which claims nearly one million lives a year, mostly in Africa. "Malaria is endemic in many countries, including India, and any breakthrough will provide succour to millions around the world," says Ranjit Shahani, President, Organisation of Pharmaceutical Producers of India.
Global pharma major Roche had handed this project to Ranbaxy Laboratories in May 2003 under a project called the Medicines for Malaria Venture. But even if Ranbaxy did not initiate work on the drug, analysts maintain its achievement in developing it and bringing it to market is a landmark. Around 80 per cent of new drugs are brought to market by the big global majors, even though only 35 per cent of such drugs have been developed by them from the earliest stage. Smaller companies engaged in research often find going the full course up to the market beyond their means and end up outlicensing their NCEs to big pharmas. That a relatively modest company like Ranbaxy has been able to bring a drug to market is creditable.
"This development is significant for three reasons," says Ajit Mahadevan, Partner, Life Sciences, Ernst & Young. "First, the therapy area (malaria) is a focus area for emerging markets and India. Second, developments like these strengthen the credentials of Indian research and open up scope for more funding for it. Finally the cost of development of a drug will be lower in India than abroad,"
Will the drug transform Ranbaxy's fortunes? Analysts feel that, since the drug cannot be priced too high, it may not boost revenues excessively, though it may give the company decent returns.
