Ranbaxy Laboratories Limited (Ranbaxy) launched India’s first new drug, Synriam, for the treatment of uncomplicated plasmodium falciparum malaria, in adults, opening a new chapter in the history of Research & Development in India. At a function held in New Delhi, Ghulam Nabi Azad, Minister of Health and Family Welfare, Government of India and Vilasrao Deshmukh, Minister of Science & Technology and Earth Sciences, Government of India, unveiled India’s first new drug Synriam with Ranbaxy dedicating the new age cure for malaria to the nation, on World Malaria Day.
The new drug, 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. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent.
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. The dosage regimen is simple as the patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days making Synriam a convenient option, leading to better compliance.
The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.
Felicitating the scientific team from Ranbaxy, Dr Tsutomu Une, chairman, Ranbaxy, said, “I applaud all our scientists who have worked incessantly over eight years and with great diligence to successfully develop a new drug. This is a tribute to the indomitable spirit of the Indian scientific community. The drug fills a vital therapy gap not only in India but also worldwide. We will make all possible efforts to make Synriam accessible to the world.”
Arun Sawhney, CEO and managing director, Ranbaxy said, “It is indeed gratifying to see that Ranbaxy’s scientists have been able to gift our great nation its first new drug, to treat malaria, a disease endemic to our part of the world. Synriam will certainly become the preferred option in the hands of doctors to fight malaria, which every year claims more than half a million lives globally. He further added that this is a historic day for science and technology in India as well as for the pharmaceutical industry in the country, as India today joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug.
Heralding the arrival of the new drug, Dr Sudershan Arora, president-R&D, Ranbaxy, said, "The new drug, 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 drug, in line with WHO recommendations. It is among the best options available today. I applaud the success of R&D at Ranbaxy in the creation of this new age cure for malaria and am sure that innovative drug products will continue to be developed at Ranbaxy-R&D labs, even in the future."
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 paediatric formulation.
Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Availability of plant based artemesinin, a primary ingredient in established anti-malarial therapies is finite and unreliable. This leads to price fluctuations and supply constraints. Most of the existing therapies have a high pill burden that increases the possibility of missing a dose. There was a critical need for a new anti-malaria drug that would address these challenges. Ranbaxy embarked upon this development project with the aim of coming up with a new anti-malarial drug that would be highly effective as well as address the issues associated with the most commonly used therapies.