On August 31st, the Indian government approved a revolutionary drug designed to cure Visceral Leishmaniasis (VL). As some of you may already know, that drug is the Paromomycin IM injection.
The approval of this drug represents a critical milestone for OneWorld Health. It not only proves that a nonprofit pharmaceutical company can successful develop an innovative drug, but it also demonstrates the company’s ability to be granted approval for the drug despite stringent guidelines. The approval of the Paromomycin IM injection means that otherwise lost lives can now be saved. In South Asia, for example, the wise use of Paromomycin IM injections could eventually eliminate the terrible scourge of VL.
In the broadest sense, the approval of the Paromomycin IM injection validated both the company’s mission and model: the develop safe, effective, and affordable medicines for people with neglected diseases in the developed world. It was the unique collaboration between OneWorld Health, Gland Pharma Limited, and the International Dispensary Association (IDA) that made the creation of Paromomycin IM possible. And without the help of IDA Solutions, the World Health Organization’s Special Program for Research and Training in Tropical Diseases (WHO/TDR), and the Indian government, none of this would have ever happened.
The approval from the Drug Controller General of India came less than 3 months after the drug’s application was submitted in collaboration with Gland Pharma Limited – the India-based drug manufacturer and OneWorld Health partner that produces the drug. Approval was based on results generated from a large, randomized, controlled study conducted with the help of countless dedicated physicians and researchers in India and WHO/TDR.
Of course, a new drug must be determined safe and effective, but for the diseases targeted by OneWorld Health, those drugs must also be inexpensive. Hence, Gland Pharma Limited will make the Paromomycin IM injections available at cost – approximately $10 per cure. But, the work is just beginning for the nonprofit. Western pharmaceutical companies can market their drugs, but OneWorld Health must find innovative ways to ensure that Paromomycin IM injections reach those who need it. To do so, the company is working closely with several colleagues from all sectors of India to develop the model and network required to meet that need.
Experimentation is already underway to develop an inexpensive treatment or cure for malaria. Continual evaluations of alternative technologies are underway to provide effective medicines for other neglected diseases as well. It was done with Paromomycin IM and it will be done again. The field of global health is experiencing a surge or renewed vigor, thanks in large part to the extraordinary leadership of the Bill and Melinda Gates Foundation who helped to inspire this world-changing crusade, proving once again that a few good ideas, a strong dose of determination, and a lot of hard work from dedicated people can ease the suffering we see the in the world.
The Institute for OneWorld Health depends on the generous support of individuals all over the world to fulfill our mission. Thank you for supporting our work and helping us develop and provide access to safe, effective, and affordable medicines for people with neglected diseases in the developing world. Please consider going to our website now, www.oneworldhealth.org to make a contribution, or call us at 415-421-4700 for further information.