Indian Pharmacopoeia Commission (IPC) in collaboration with Revised National Tuberculosis Control Programme (RNTCP) and WHO will provide training to six identified tertiary care centres allowed to prescribe bedaquiline. The training will focus on active surveillance or cohort event monitoring of bedaquiline on patients suffering from multi -drug resistant tuberculosis and will be held in IPC from September 6 to 9.

Early March this year, health minister J P Nadda had launched bedaquiline, a new anti-TB drug for drug resistant TB as part of the Revised National Tuberculosis Control Programme. To prevent misuse of this new anti TB drug, DCGI had put it under strict vigilance introducing it only at select centres across India.

At present, only six RNTCP centres having advanced facilities for laboratory testing and intensive care for patients are allowed to prescribe bedaquiline by the DCGI. Incidentally, they are also registered AMCs under the Pharmacovigilance Programme of India (PvPI), informed Dr Kalaiselvan.

The training programme will highlight the importance of regular monitoring for adverse events and special measures required to ensure the early detection and timely reporting of adverse events using active pharmacovigilance method like cohort event monitoring. He added that this training module is designed to sensitise officials to effectively report any adverse drug reactions in patients due to use of bedaquiline.

Unlike the usual ADR reporting, these AMCs will be actively conducting the surveillance of the patients from the time of their enrollment till the completion of their course.

Bedaquiline tablet approved as part of combination therapy for pulmonary tuberculosis due to MDR TB, when an effective regimen cannot otherwise be provided, has potential of creating unrecognised drug interactions.

This is a strategic move aimed at strengthening the PvPI programme especially since, TB treatment has always been plagued with adverse drug reactions (ADR) often resulting in treatment interruptions by patients. This has further contributed to avoidable morbidity, treatment failure, reduced quality of life, or death.