The disease has been around for centuries; mummies of dynastic Egypt were found affected as far back as 3000 BC. It is believed to have evolved from the bovine to the human form 5000 years back. In India it has reached alarming proportions in recent years. We account for a quarter of the worlds’ annual incidence of tuberculosis. Every year two million Indians develop the disease and over 300,000 die of it. Whilst in the past, cure rates have been above 85%, recent developments prompted the government to make it a notifiable disease in 2012 because “an unregulated and unmonitored private sector accounted for about half of the Tb. care delivered.”
The notification was amended in 2015, to provide definitions and follow-up actions. A Tb case was defined as 1. “A patient with at least one specimen positive for the bacillus or a positive culture or a positive rapid diagnostic molecular test” or 2. A patient diagnosed clinically as a case of Tb without microbiologic confirmation and started on anti-Tb. drugs”. Once the practitioner notified a case the government health systems would initiate the following measures. A health care worker would make a home visit and counsel the patient and family members. Treatment adherence and follow-up support for treatment completion would be ensured. Contacts would be traced, with symptom screening evaluation of Tb. symptoms, and drug prophylaxis (INH) for eligible contacts. In selected cases HIV testing and Drug Sensitivity Testing (DST) would also be provided. All this would be backed by the “NIKSHAY” electronic Tb notification system. The order was made applicable to all health care providers and laboratories whether in the government or private sector.
The WHO, DOTS and MoHFW published the “Standards for Tb. Care in India” (STCI) and the supplementary “Index-Tb Guidelines”. Sweeping measures were required because of WHO findings. 2.1% of all new cases in India are Multi-Drug Resistant Tb (MDR-TB), while as many as 15% of re-treatment TB cases were developing MDR-TB. Nearly 100,000 cases of serious MDR-TB are estimated to occur in the country annually, and each MDR-TB case costs more than Rs 1 lakh to diagnose and treat, often complicated by the fact that Tb. and HIV often go hand in hand.
A number of reasons for MDR were identified. The private sector is the first point of contact for treatment in more than 60% of cases, and it is alleged that private doctors used irrational combinations, making them drug resistant, and then landing up in the government treatment program. Such allegations do not factor in the issue of unqualified “doctors” in practice (over half of all “practitioners”), deficiencies in quality control and availability of unregistered medicines. In one study, 10% of drugs available for treatment of Tb. were found to be spurious. In spite of this the Union Health Minister declared that Tb. will be eliminated in this country by 2025.
The STCI recommends that any patient, including children, with symptoms and signs of disease including a cough and fever for more than two weeks with weight loss or blood in sputum (hemoptysis) should be evaluated for Tb. Screening programs should include people living with HIV patients, malnourished, diabetics, cancer patients and those on immune-suppressive therapy. The debate arises over the best available tests.
India faces criticism for its’ reliance on the sputum smear test for diagnosing Tb. This is not the most sensitive test and prone to false negative results especially in HIV patients. A chest X-ray can be used as a screening tool but serological tests are banned. The Tuberculin skin test is not recommended and may be used as a complimentary test in children. Newer tests like rapid molecular tests to diagnose as well as detect drug resistance should be used extensively. The STCI document gives due weightage to the CB-NAAT (cartridge bases nucleic-acid amplification test) in children and people living with HIV. However such “Xpert MTB/RIF” should be made standard across the country. The issue is one of cost, but as per WHO observations, the cost of missing a case or failing to detect drug resistance is far greater. Currently, India has only 735 planned installations (of Xpert MTB/RIF), and a committed increase to take the number up to 1,019.However the availability of Drug Susceptibility Testing (DST) is still severely lacking. Lifesaving drugs needed in cases of drug resistance are not freely available partly because India been slow in its’ approval for their use. Further, these are extremely toxic particularly to the liver and must be used under strict medical supervision. The term MDR-Tb could relate to rifampicin or isoniazid, and each of these need different approaches. Specific recommendations are made for resistance in children, and pediatric dosages should be available, as opposed to dividing adult dosage tablets.
Then there is the problem of extra-pulmonary Tb. We commonly identify Tb. as a lung infection. However in some series, as much as 20% (and in HIV population 50%) of infections occur outside the lung, collectively referred to as ‘extra-pulmonary”; for example abdominal, genital or bone and joint infections. The skeletal infections present special diagnostic difficulties. Isolating the organism even by biopsy presents difficulties with inconclusive reports. Here the CB-NAAT tests would be particularly useful. A further unresolved issue is of duration of treatment. The usual follow-up parameters for chest infections are not available, and recommendations vary from six, nine, twelve and eighteen months, with a four drug regimen for two months and a three drug regimen thereafter. The “Index-Tb Guidelines” have helped clear the air somewhat.
Against this background of confusion and criticism, it is commendable that the Voluntary Health Association of India, with its Axshya program, in collaboration with DHS and WHO recently held two workshops in North and South Goa to sensitize practitioners on STCI recommendations for diagnosing and treating Tb. However it remains obvious that we still have “miles to go”.
(The writer is a founder member of the Voluntary Health Association of Goa.)
