‘Scientists felt this should be done as an implementation research study’

It is more of an intervention, a research implementation study. You are right that there is not enough evidence that it is going to reduce incidence of tuberculosis (TB).

When the ministry started this, the feeling among scientists was that this should be done as an implementation research study. So there are districts where the BCG (Bacille Calmette-Guerin) vaccine is being rolled out to vulnerable groups and control districts. I do not think that intervention is something that can be scaled or should be scaled without further data and information. I hope that this exercise can really be used to generate that data. So this could be one of the largest studies of this kind.

Generally, BCG is a safe vaccine, with a long history of use. Side effects are likely to be minor. Of course, one cannot say there would not be any adverse effects. Even if they are not severe, they can cause discomfort to people. One does not expect any major side effects. But in any intervention it is benefit versus risk. We do need to capture the effectiveness as well as any side and adverse effects.

If you ask my personal opinion, it should have been done more of a trial— a phase-4 trial could have been done in a large population—but treated more like a research study than a programmatic intervention. It would have been an ideal approach to gather up the scientific evidence and data. The downside of doing it like this is that the programme has its limitations, and has many priorities. You are going to spend the time of the staff doing this rather than on other priorities. And, secondly, data collection for something like this has to be done well in order to generate the right amount of information on effectiveness and safety.

I do not think it was ever realistic. You cannot go from a high-TB-burden country to elimination in five years... To me it was political ambition and commitment by the government. It was welcome that there was so much political will to tackle TB.

My first priority is to bring down TB deaths to as low as possible and then get down to reducing the incidence for which everybody agrees, we need new tools, so without more R&D and without development of more diagnostics, it is going to be very hard. We still don’t understand a lot of things about TB.

Sub-clinical TB now is being discussed a lot. A lot more research is needed in addition to strengthening the programme. But on mortality, we should be able to achieve a quick decline. Other countries have done it so that’s a very doable goal and it will show we are capable of hitting some targets. TB elimination is much more difficult, but getting TB deaths down is doable.

One of the other strategies that the ministry is working on is rolling out the BPal regimen. It is something that is already being worked on and should happen very soon (BPaL/M is a six-month, all-oral treatment regimen composed of bedaquiline, pretomanid, linezolid, with or without moxifloxacin. It is a therapy for people with drug-resistant tuberculosis).

Malnutrition is one of the biggest risk factors for TB. The Government has tried to improve nutritional support for TB patients with schemes like nikshay poshan and poshan mitra. That’s an area we need more discussion and focus. We also need to scale up molecular testing.

If we can go from where we are today—from 30 per cent of upfront diagnostic to 100 per cent molecular testing -- for all presumptive TB cases, it will have a huge impact. Because this will reduce the delays in diagnosis and reduce transmission.