Govt clarifies on MDR-TB drug ‘Bedaquiline’ controversy

The union health ministry has clarified that the Bedaquiline which is used in selective cases, is available only through Revised National TB Control Programme (RNTCP) and open market sale of the drug is not permitted in India as of now


New Delhi: As per Global TB report 2017, estimated number of Multi Drug Resistant (MDR) Tuberculosis patients are 6,01,000 globally, of which 147000 that means one fourth, are estimated from India.

During 2016, the drug ‘Bedaquiline’ was introduced in India under conditional access programme for selective group of the Multi drug resistant TB patients based on drug sensitivity results of second line anti TB drugs.

However, the Nobel Laureate, Sir John Walker had recently raised concern about the already known cardiotoxicity associated with the drug Bedaquiline.

Clarifying on the issue in the upper house of Parliament, the Minister of State (Health and Family Welfare), Mr Ashwini Kumar Choubey has stated that Bedaquiline drug is manufactured by Janssen & Janssen, a subsidiary of Johnson and Johnson, at 100 percent export Special Economic Zone (SEZ), Bangalore, India. In India, this drug is available through Revised National TB Control Programme (RNTCP) only and open market sale of Bedaquiline is not permitted by Drug Control General of India (DCGI) as of now.

Replying to another query, Mr Ashwini Kumar Choubey informed that after the Prime Minister’s letter to Chief Ministers on TB, several States and Union Territories (UTs) have established review committees under the Chairmanship of Health Minister or Secretary (Health) at the State level. Similarly, the States/UTs have also established review committees under the District Collectors/Magistrates at the district level. The State level reviews are conducted quarterly, and the District level reviews are conducted monthly.

The Central Government is regularly monitoring the State Governments on implementation of the Revised National Tuberculosis Control Programme (RNTCP) and has guided the States to establish State and District level forums involving all stakeholders for ensuring a holistic approach and community led response towards addressing the problem related to Tuberculosis, revealed the Minister.