In the wake of implementation of Short Course Chemotherapy (SCC) in the programme, some of the organizational aspects of SCC as observed in a clinical trial at the Lady Willingdon State TB Centre (LWSTC), Bangalore vis-a-vis to those recommended in the programme were evaluated. The efficacy of 3 SCC regimens of 3-5 months duration under clinical trial were studied among 381 patients. The efforts and the resources employed to achieve the results in the trial are compared with that of those recommended in the District TB Programme (DTP).

It is observed that there is a wide gap between the clinical trial and the programme in organisational efforts and resources. Although the trials cannot act as a model, if benefits associated with the SCC are to be availed, extra staff and transport for home visiting should be provided. The aspects of the organisation which need strengthening are motivation, timely defaulter action (preferably on the same day mainly as home visit) and efficient management of large number of patients attending the clinic for supervised drug administration, adverse reaction etc., before recommending the use of SCC in the DTP.

The high rate of treatment completion and the regularity of drug intake achieved in clinical trials of Short Course Chemotherapy (SCC), could possibly be attributed to efficient organizational set-up, careful selection of cases and all-out effort to control defaulters. The organizational effort put forth to achieve the regularity is relevant to the applicability of SCC in the existing set-up of District Tuberculosis Centres (DTCs) under National Tuberculosis Programme (NTP). First 300 patients admitted to SCC trial to assess the efficacy of three drug regimens of 3/5 months duration under fully supervised conditions, carried out jointly by National Tuberculosis Research Centre, Madras and National Tuberculosis Institute (NTI), Bangalore, have been analysed for the purpose.

To keep up the regularity, 1/3rd of the patients required home visits-some of them repeatedly. If the actions of the same intensity of defaulter retrieval in the form of home visiting are envisaged to be taken in a DTC with the normal working pattern catering to 500 patients, 250 to 300 home visits will have to be made in a month. This may not be feasible in the existing set-up of NTP. A new strategy of defaulter retrieval actions for programme conditions may have to be devised. Further, selection of drug regimen which has the maximum potential of being given on self-administered basis may reduce the work-load to a considerable extent. Drug toxicity, side effects and the cost of drugs may not be major handicaps. However, the only way to understand various operational problems is to undertake scientific operational studies in actual working conditions of NTP.

A controlled clinical trial of the three Short Course Chemotherapy (SCC) regimens was carried out at the Lady Willingdon State Tuberculosis Centre, Bangalore and Tuberculosis Research Centre, Madras with the collaboration of National Tuberculosis Institute, Bangalore. The regimens were (1) R3: (rifampicin, streptomycin, isoniazid and pyrazinamide daily for 3 months (3RSHZ); (2) R5: same as regimen R3, followed by streptomycin, isoniazid, pyrazinamide twice weekly for 2 months (3RSHZ/2S2H2Z2); (3) Z5: same as regimen R5 but without rifampicin (3SHZ/2S2H2Z2). Newly diagnosed tuberculosis patients who were aged 12 years or more had no history of previous treatment and two sputum cultures positive for M.tuberculosis were taken to the study and allocated at random to one of the above stated three regimens. The patients were given supervised chemotherapy as out patients. Sputum specimens were examined by fluorescent microscopy, culture by modified Petroff's method, tested for sensitivity to INH, rifampicin, streptomycin and ethambutol. The follow up was done by sputum smear and culture examination at the end of every month for 2 years. The distribution of various pre treatment characteristics like age, sex, and initial sensitivity status were similar in the three series. At the end of 3 months, of the 455 patients on R3, and R5 series, 96% with drug sensitive organism became culture negative and of 235 on Z5 series 93% became culture negative. For R5 and Z5 series favourable response at the end of chemotherapy were 96%, 99% and 97% respectively. In all, 6 patients (3 R3 & 3 Z5) were classified as having unfavourable response. At the end of 24th month from the date of start of treatment, 20% of the 200 patients on R3, 4% of 187 patients on R5 and 13% of 199 patients on Z5 had bacteriological relapse. The difference between R3 and Z5 series was highly significant. (p = 0.00001). The relapse rates in R3 & Z5 series were significantly higher than that in R5. Of the 57 patients with initial drug resistance organisms in R3 and R5 series combined 4 had an unfavourable response to treatment compared with 13 of 26 in the Z5 series (p = 0.0001). Of the 4 patients with an unfavourable response in R3 and R5 series combined, resistance to rifampicin emerged in 2 patients. Complaints of arthralgia were made by 45% of the R3 and R5 patients combined and 70% of Z5 patients (p = 0.00001). However, chemotherapy was modified in only 5 and 12% respectively. Jaundice occurred in 7% of the R3 and R5 patients and 1% of the Z5 patients (p = 0.0001).

Government of India set up a plant for producing Freeze-Dried vaccine at BCG Vaccine Laboratory, Madras in 1959. Before releasing the freeze-dried vaccine to the mass campaign it was necessary that it is subjected to various tests. This paper deals with two such trials. The first study planned in this connection was for the assessment of allergising properties of two lots each of four batches of freeze-dried vaccine. The second study was to investigate the stability of two lots of a batch of freeze-dried vaccine in relation to storage at different temperatures for varying periods.

The results indicate that though the liquid vaccine has on the whole produced slightly higher allergy than the freeze-dried vaccine, the level of allergy achieved with the freeze-dried vaccine is quite adequate. Levels of post-vaccination allergy in the lots containing glutamate and tween 80, show that increase in storage temperature has resulted in higher loss of potency of vaccine. No definite trend is indicated regarding the lots containing glutamate alone.