MDR TB drug by Otsuka made its way to India

Otsuka Pharmaceutical, a Japanese drug maker, has granted an exclusive license to supply to India and South Africa a drug to treat patients with pulmonary multi-drug resistant tuberculosis (MDR TB) for US pharmaceutical firm Mylan’s subsidiary. The agreement is expected to accelerate India’s access to the potentially life-saving drug, which had not been available in the country despite Otsuka having received a patent for it back in 2011.

The drug had not been available in the country despite Otsuka having received a patent for it back in 2011.

The Drug Controller General of India (DCGI), India’s apex drug regulator, has granted Mylan’s subsidiary approval for the drug. The drug, delamanid, was discovered and developed by Otsuka.

The Revised National Tuberculosis Control Program (RNTCP) will now begin drafting the protocol to administer delamanid with other drugs to patients with MDR TB and identify sites where the drug will be rolled out. Mylan will use clinical data from these sites to conduct a post marketing survey, after which DCGI may give them permission to introduce it in the private market.

The government intends to enter into discussions with Mylan to ensure that delamanid remains affordable to India.   Drugs for patients with MDR TB is becoming an issue in the country, the only other drug available in India is Bedaquiline by Johnson & Johnson. This drug was introduced last year and is also supplied to a limited number of patients through the government's conditional access program.