India’s
Ranbaxy Laboratories Limited has launched the country’s first
indigenously-developed anti-malarial drug, Synriam.
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 vivaxmalaria 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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