India: 1st in 50 years: Nod for new tuberculosis drug
Bedaquiline is in use in US and EU against multidrug-resistant strains
With cases of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant TB (XDR-TB) threatening the country, Bedaquiline the first anti-TB drug manufactured after Rifampicin (almost 50 years ago) has been approved for use in India. Bedaquiline is so far approved in the US, EU and other major countries. In a recent meeting, India’s apex committee on drugs recommended waiver of local clinical trials for the drug and suggested its use under the government’s run programme for TB.
Bedaquiline is indicated for the treatment of pulmonary TB due to multidrug-resistant Mycobacterium TB for which presently there is no effective therapy available in India. According to experts MDR-TB is a serious life threatening condition with high mortality and is a disease of special relevance to Indian health scenario. Therefore, the apex committee in its recent meeting recommended “waiver of local clinical trials at this stage” with a restriction that it “shall be approved for use under government run Revised National TB control Programme (RNTCP)” framework for conditional access for treatment of MDR-TB patients only.
Earlier, the drug manufacturing firm had presented pre clinical and clinical data on the safety and efficacy of the drug and requested for the waiver of requirement of phase III clinical trails in India.
However, it was noted that as part of global clinical trial only five patients were enrolled from India. The subject expert committee therefore did not consider number of subjects from India adequate to address the safety concern and did not recommend for the waiver of clinical trial.
The recent recommendations of the apex committee have therefore come as a respite for a country where TB kills two Indian every three minutes and drug resistance is growing at an alarming pace.
Source: The Asian Age
