At the centre of the TB drug shortage and procurement logistics issues is the controversy over the daily vs. intermittent drug therapy for TB.
The RNTCP follows an intermittent drug regimen of three drug-days a week. However, outside of RNTCP, all chest physicians prefer to put their patients on a daily drug regimen of tailor-made drug combinations and dosages.
For a long time, the government has been trying to bring the private sector into the RNTCP fold so that there is universality in the manner in which TB is treated across the country. But there has been stiff resistance from the private sector. India is currently the only nation in the world to follow the intermittent drug regimen for TB. The rationale for choosing this therapy was the convenience in implementation and lowered toxicity and adverse drug reactions.
The WHO revised its TB management guidelines in 2010, recommending that the daily drug regimen be adopted under RNTCP. This was because the default rate in the intermittent regimen seemed to be high, encouraging drug resistance.
However, the Central TB Division is yet to reach a consensus on the regimen. Its argument is that various clinical studies have proven that the intermittent regimen is as effective as the daily regimen. “The intermittent regimen would be effective if the direct observation of treatment, as envisaged in the RNTCP, was actually happening in the field. A daily drug regimen is easier to follow than a three dose/week regimen. Also, our chest physicians feel that the TB bacillus has changed in dynamics over the years and that the current surge in drug-resistant TB across the country is proof enough that the intermittent regimen is not enough,” Dr. Ashokan says.
“’Kerala’s dilemma now is that the TB drugs for intermittent regimen are not available in the open market. If we have to go for local purchase, then we have no option but to adopt the daily regimen. We have proposed that a high-level technical committee look into this issue immediately and inform the Centre,” a senior Health official said.
When contacted, D. Behera, a senior member of the National Taskforce on TB Control, told The Hindu that the Union Health Ministry had not yet accepted the daily drug regimen for TB.
“The technical committee feels that there are serious practical difficulties in adopting the daily drug regimen in RNTCP because we are treating several lakhs of TB patients. The committee feels that a final decision cannot be taken without piloting the daily drug regimen in at least a few districts,” Dr. Behera said.