Not by government alone

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 8212; not-for-profits as well as commercial entities 8212; 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 Serum8217;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 azar8217;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 8212; all of which have districts where kala azar is endemic 8212; 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 8212; 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