AsianScientist (Apr. 26, 2012) – India’s Ranbaxy Laboratories Limited has launched the country’s first indigenously-developed anti-malarial drug, Synriam.
Synriam, used to treat uncomplicated Plasmodium falciparum malaria in adults, has been approved by the Drug Controller General of India (DCGI) for marketing in India and conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria.
Phase III clinical trials for the drug conducted in India, Bangladesh, and Thailand successfully demonstrated the efficacy and tolerability of Synriam as comparable to the combination of artemether and lumefantrine.
According to Ranbaxy, the drug provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 percent. The dosage regimen is also simple, at just one tablet per day, over three days. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies.
“This is a historic day for science and technology in India as well as for the pharmaceutical industry in the country,” said Arun Sawhney, CEO and Managing Director, Ranbaxy, at the launch event. “Today, India joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug.”
The New Delhi launch event was also attended by Mr. Ghulam Nabi Azad, Hon’ble Minister of Health and Family Welfare, Govt. of India; and Mr. Vilasrao Deshmukh, Hon’ble Minister of Science & Technology and Earth Sciences, Govt. of India.
Synriam, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg, explained Dr. Sudershan Arora, President-R&D, Ranbaxy.
Ranbaxy is also working to make this new treatment available in African, Asian, and South American markets where malaria is rampant. Synriam trials are ongoing for Plasmodium vivax malaria and a pediatric formulation.
India alone accounts for over 75 percent of the 2.5 million reported cases of malaria in Southeast Asia. Notably, around 117 districts in India are chloroquine resistant, and Synriam has been shown to be effective in these geographical regions.
Source: Ranbaxy Laboratories Limited.
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