Striking the right balance: Accessing New Anti-Tuberculosis Drugs in India

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Abstract

In December 2012, the US Food and Drug Administration (USFDA) gave accelerated approval to bedaquiline (1). A second new chemical entity, delamanid, received approval from the European Medicines Agency in November 2013(2). These are the first new drugs active against sensitive and drug resistant forms of tuberculosis (TB) in decades (3).

In 2013, the Indian Ministry of Health (MoH) formed a high-level committee to discuss how to respond to this historic opportunity and to determine the way newer TB drugs will be used in India (4).

As a medical humanitarian organisation faced with the challenge of treating drug-resistant tuberculosis (DR-TB) in its Mumbai, Mon (Nagaland), Churachandpur (Manipur) and Chattisgarh medical projects, Médecins Sans Frontières (MSF) welcomes this important step. India faces major challenges with respect to TB, due to a large burden of cases and an increasingly recognised number of drug-resistant strains. DR-TB is becoming a serious public health challenge in India (5,6) and new treatment options for patients with strains having advanced resistance (e.g. extensively drug-resistant TB or XDR-TB) are desperately needed.

But accelerated access to these new treatment options comes with the challenge to prevent the irrational use or misuse of these drugs, a practice that had a role in the emergence of widespread resistance to older antibiotics and anti-TB drugs in the first place(7). MSF is therefore concerned that access to these new drugs be secured for patients diagnosed with XDR-TB, and at the same time, stricter regulation of these new drugs be implemented by the Drug Controller General of India (DCGI) and Ministry of Health in India. This briefing document outlines some of the issues that MSF would like the Expert Committee on “Regulation of Newer TB drugs in India” to consider.