With the announcement of approval to market for its new malaria medication SynriamTM the Indian pharmaceutical company Ranbaxy has led India past an important milestone: the production of its first indigenously produced drug treatment. India has long been a successful maverick in the world of international pharmaceuticals, frequently denying or rescinding patents from multinational drug corporations or approving generic drugs before patents have expired. Indian law allows for loss of patent rights in the case of clear overpricing or unfair extension of patents for existing drugs. One result of this policy has been that India not only produces over 80% of the world’s HIV medication but that some recently developed cancer medications are available in India for 1/30th of the price that they are supplied in more economically developed countries. Another is that India is now the 3rd largest producer of pharmaceuticals in the world and its market is now estimated over $20 billion .
Although the success of Indian Pharma has been based around the mass production of generic drugs for the domestic market, almost half of India’s pharmaceutical production is now exported and approximately 2% of Indian Pharmaceutical revenue is now invested in pharmaceutical Research and Development. SynriamTM developed by Ranbaxy, is the first drug developed by an Indian pharmaceutical company in India, that underwent trials there, was granted a license and which has now reached the marketplace.
World Health Organization estimates that some 1.3 million cases of malaria occur in India each year. Of these roughly half are Plasmodium vivax and half are Plasmodium falciparum. Few drugs are effective against both, but there has been an obvious and considerable need for one that is. SynriamTM is formulated from two synthetic drugs. The newly developed and rapidly acting trioxolone, arterolane, is one that has been developed by the Medicines for Malaria Venture (MMV) and may act analogously to artemesinin . The longer-lasting piperaquine which was developed in China in the 1950s has been widely used previously and has also been used in formulations with artemesinin . Synriam TM is given as an oral tablet one per day for three days and is reported to be effective against more than 95% of vivax and falciparum malaria cases. It is clear that Synriam TM is a success story for India and for the MMV program and will have considerable impact on malaria once it is introduced. With many more drugs known to be in the development pipelines of Indian Pharma, SynriamTM may be India’s first indigenously produced new drug therapy but it is unlikely to be the last.
2. Vennerstrom, Jonathan L.; Arbe-Barnes, Sarah; Brun, Reto; Charman, Susan A.; Chiu, Francis C. K.; Chollet, Jacques; Dong, Yuxiang; Dorn, Arnulf et al. (2004). “Identification of an antimalarial synthetic trioxolane drug development candidate”. Nature 430 (7002): 900–4.
3 D’alessandro U. (2009). “Progress in the development of piperaquine combinations for the treatment of malaria”. Curr Opin Infect Dis 22 (6): 588–92.
*The author declares that he has no competing interests
If Synriam is formulated from two previously developed drugs how can it be termed indigenous?
Arterolane isn’t a “previously developed drug” it was initially developed by as a promising lead compound by MMV, but it has come through human trials as part of this novel treatment formulation from Ranbaxy for the first time. While the drug development of the component compounds was certainly a multinational business, the Synriam TM formulation and treatment are entirely indiginous to India.