During mid-June of 2006, the Institute for OneWorld Health, alongside Gland Pharma Limited, offered a dossier to India’s Drug-controller General. Several weeks after the dossier was submitted, Paromomycin IM (instramuscular) injection became an approved drug for (VL) Visceral Leishmaniasis treatment.
Gland Pharma Limited manufactures this injectable drug and will handle distribution of the medication within India. The Paromomycin injections which are purchased will be utilized for the India-based NVBDCP (National Vector Borne Disease Control Program). In the future, the drug may be available within Bangladesh, as well as Nepal, via a facet of VL elimination programs in South Asia.
Non-Profit Funding Made It Possible
Funding for this new initiative came from The Bill and Melinda Gates Foundation. The funding allowed OneWorld Health to collaborate with a non-profit agency for drug supply within the Netherlands. The agency is called IDA. IDA manufactured the drug for the third phase of trials (VLPM01), via a subsidiary of IDA, which is known as PPL (Pharmamed Parenterals Ltd). PPL is based in Malta.
The active pharmaceutical ingredient in this new injectable medication was created in Italy, by Antibioticos. In the past, IDA has made paromomycin for Doctors Without Borders, who needed it to treat patients in South Sudan. During the Phase III clinical trial in India (VPLM01), OneWorld Health found that results were good and this prompted iOWH to partner with a subsidiary of IDA, known as IDA Solutions, which is, like IDA, based in the Netherlands. The subsidiary specializes in project organization and specialized consultancy, for Access to Drugs for Tropical Diseases.
Next, tech which related to producing the injectable medication was given to Gland Pharma Limited (in India). The existing dossier which was submitted via Gland Pharma Limited, for regulatory approval of the drug (as a treatment for patients with VL) is meant to provide a safer, more effective treatment. It’s designed to battle the VL epidemic in poor sections of Bihar state and surrounding areas.
This new public/private partnership should meet global demand for Paromomycin Injection.
Lots of Partnerships Are In Place
In addition, OneWorld Health is liaising with WHO, the World Bank and India’s government, in order to ensure that the two programs are supported. These programs are the National Vector Borne Diseases Control Programme and the National Plan for Regional Kala Azar Elimination Program. Medical researchers in important research centers are taking part in vital clinical studies. Also, many NGOs will going to partner during the fourth stage of the study. The partner NGOs will analyze delivery systems, social marketing ideas and other important facets of making this drug available to those who need it most.
In general, VL strikes those who live in remote areas which don’t have good infrastructure for health care. Now that OneWorld Health and Gland Pharma Limited have come together, with the help of the Bill and Melinda Gates Foundation, it will soon be easier for citizens of India who do live in remote villages and regions to get the important medication that they need. This new partnership will move treatment of VL in India forward.