Govt negotiating with firms for better access to new tuberculosis drugs

New Delhi: The government is negotiating with Johnson & Johnson and Mylan Inc. to improve Indian tuberculosis (TB) patients’ access to new antibiotic wonder drugs such as Bedaquiline and Delamanid, two people aware of the matter said.

The government wants the drug makers to provide treatment for multi-drug resistant (MDR) TB patients as part of the government-run Revised National Tuberculosis Control Programme.

The Prime Minister’s Office (PMO) along with the ministry of health and family welfare are in the talks with the companies, ahead of the “End TB Summit” where Prime Minister Narendra Modi is expected to announce India’s plan to eliminate TB by 2025 on Tuesday, the two people said, requesting anonymity.

A Mylan Inc. spokesperson said, “We are working closely with the Government of India, the Revised National Tuberculosis Control Program and Otsuka toward making Deltyba® accessible to patients suffering from multi-drug-resistant TB and are committed in our endeavor to do so.”

At the summit, Modi will announce a National Strategic Plan for TB elimination, which is backed by a funding of over Rs12,000 crore over the next three years to ensure every TB patient has access to quality diagnosis, treatment, and support.

“In a major push to the treatment, a new Drug susceptibility test (DST) guided treatment will be announced by the PM on Tuesday,” one of the two people cited above said. The test determines which drugs will work on the patient and this information will help the doctor to prescribe a treatment regimen.

At 79,000, India has the highest number of multi-drug resistant patients who don’t respond to the two most powerful TB drugs.

The government is trying to bring down the prices of the new antibiotics and a meeting was held in the PMO last Friday on the matter, the second person said.

While Bedaquiline is sold under the brand name Sirturo by a unit of Johnson & Johnson; Delamanid is sold by Japan’s Otsuka Pharmaceutical Co. and by Mylan in India.

Mylan and Otsuka have recently initiated a technology transfer process, which would allow for Mylan to manufacture Deltyba®. “Deltyba® is one of only two new medications developed for MDR-TB in the last 40 years. It is registered in the European Union, Japan, the Republic of Korea, Hong Kong, Turkey and India. Since regulatory approval, more than 4,000 treatment courses of Deltyba® have been shipped for use in over 50 countries,” the Mylan spokesperson added.livemint

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