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.

... contd.