
Kala azar is eminently preventable and curable. The parasite that transmits the disease is the sandfly. An extensive and effective vector control programme can go a long way in preventing transmission of the disease.
In terms of those who already have the disease, treatment can be provided in India. The problem is that the drugs authorised by the public health system to treat the majority of patients either take very long in terms of the period of treatment or are toxic or very expensive. Patented by an Indian company, an emulsion of amphotericin B offers a single-day, single-course treatment. It has been in the market for five years now, but is not part of the public health system.
The problem and the solution have been identified, what is missing is a road-map.
The model for kala azar eradication is a cross-sectoral public-private partnership (PPP). This is not an option but a necessity. Introducing and deploying a new public health innovation cannot just be the responsibility of a government. A host of other players, from multilateral agencies to private players — not-for-profits as well as commercial entities — have to get involved.
A quicker, more efficacious drug for kala azar is a quest being pursued by more than one consortium. The Bill and Melinda Gates Foundation and the Drugs for Neglected Diseases Initiative (DNDi) are both supporting separate projects for developing and clinically testing cheaper and shorter treatment kala azar drugs. To some degree, this would amount to reinventing the wheel. Bharat Serum’s single-day treatment, based on an emulsion of amphotericin B, is already available.
How can it be used to help patients in India and the rest of the world? Since most of kala azar’s victims are poor with little purchasing power, the treatment has to be administered through the public health system and government hospitals. Here we step into a complex regulatory web that can become so time-consuming as to be an end in itself.
There are two parallel processes, one for India and the other for the world. In our country, to allow state government hospitals to use the drug, it has to be first approved by the National Vector-Borne Disease Control Programme (NVBDCP), a Union government agency under the ministry of health and family welfare.
Once the NVBDCP authorisation comes through, state governments in Bihar, Jharkhand, West Bengal, Assam and UP — all of which have districts where kala azar is endemic — will be able to put the drug on their quantity contracts, and allow for supplies at competitive rates through government-run hospitals.
To get the Indian-made drug to be used elsewhere it is important to have it included in the WHO list of essential drugs. The WHO will do this only after it receives the appropriate protocol from the Indian Council of Medical Research (ICMR) certifying that a Phase III clinical trial of the drug has been successful.
The ICMR is a body under the Union ministry for health and family welfare. In India, in all likelihood a kala azar clinical trial would fall under the aegis of the Rajendra Memorial Research Institute (RMRI), an ICMR affiliate based in Patna. The RMRI is a central government institution, but the clinical trial would be facilitated by the state government, with drugs supplied by the pharmaceutical company (a for-profit organisation), carried out by a clinical research organisation (CRO, also for-profit), and would need non-governmental and community-based organisations (not-for-profits) to carry the message to the trial hinterland.
The clinical trial could be funded by the government or by global not-for-profits. A multilateral agency like WHO would perhaps want to review and monitor the trial process.
If any one hinge is not in place the entire edifice could fall. It is vital to have the support of all partners in this endeavour. We urgently need partnerships which are cross sectoral interactions aimed at achieving convergent objectives. Right now kala azar and poverty feed on each other, creating a vicious circle. This has to be replaced by a virtuous triangle — authorising environment (government, multilateral agencies, not-for-profits) has to combine with operational capacity (government capacity for speedy approval and industry capacity to produce in robust quantities) to produce public value (eradication of kala azar).
If we can do it with kala azar, we can do it with other diseases.
The writer is a lawyer and Mumbai-based management consultant