US drug maker Johnson and Johnson will offer its new tuberculosis (TB) drug, Bedaquiline, at $900 (Rs 70,000) once its conditional access programme with the government of India ends in 2019, the company said in an interview to ET.
Used in the treatment of multi-drug resistant (MDR) TB, Bedaquiline antibiotic has come into the market after 40 years. J&J said India is eligible for the lowest global price and that it is working on a sustainable access strategy.
“Recognising the ongoing and significant burden of TB, we are in conversations with the Indian government to ensure affordable and sustainable access to bedaquiline in the long term, once the Janssen-USAID donation programme comes to an end in early March 2019,” said Sanjiv Navangul, managing director, J&J India.
The conditional access programme offers 10,000 courses of treatment to be administered across six centres in India. J&J said the government has received 6,750 courses of this, with the remaining to be delivered within the “agreed timelines placed by the Central TB division.” For the US drug maker, Bedaquiline is one of the portfolio it is betting on for markets such as India and South Africa, where the TB burden is high.
ITS SHARE OF CONTROVERSY
As medical professionals, drug researchers and patient rights activists groups have raised different issues on the efficacy of the drug. The USFDA gave Bedaquiline a conditional approval on the basis of a phase 2 studies, which means the drug has to be administered following certain protocols.
The company has also been accused that Indian patients who were administered the drugs were not told that they were part of a clinical trial through the conditional access programme (CAP). However J&J denied these accusations and said its partnership with the Indian government through the CAP is not a clinical trial but “will help generate real-world experience, for the national TB program to evaluate and explore opportunities for expanded access to bedaquiline for patients in India”.
“We have been working closely with the government of India on the appropriate rollout and use of the drug. We have communicated the safety aspects of bedaquiline to the Indian government and trained more than 12,000 physicians on the clinical management of the drug. The patient information booklet also covers safety information regarding the drug”, Navangul said. The drug has also raised scepticism among drug researchers.
In an interview with ET in June this year, Nobel laureate John Walker said Bedaquiline might not be without side effects, and there should be enough data before expanding the drug roll out. This is what has alarmed scientists like Walker.
“We should wait for more data to emerge. You have to approach in a step-wise manner and expand gradually once it becomes clear if there are not any contraindications,” Walker has told ET.
