No proposal to introduce new TB drug: Government

Tuesday, April 30, 2013

New Delhi: There is no proposal to introduce TB drug Bedaquiline in the Indian market, parliament was told on Tuesday.

“No application under the Drugs and Cosmetic Rules has been received by the Drug Controller General (of India) for the grant of permission to market the drug,” Health Minister Ghulam Nabi Azad told the Rajya Sabha in reply to a question.

A new drug can only be introduced in the Indian market after due approval from the Drug Controller General of India (DCGI).

The prevalence of TB cases in the country is showing a declining trend. The estimated prevalence of TB has been brought down from 586 per lakh (1,00,000) population (1990) to 249 per lakh population in 2009, according to the WHO global report 2010. [IANS]

Bedaquiline (Sirturo) is the first new medicine to fight TB in more than 40 years, and is specifically approved to treat multi-drug-resistant tuberculosis.

In December 2012, the US Food and Drug Administration (FDA) approved Sirturo (Bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

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