Mumbai: In less than a month from now 400 patients, across seven states in India, will have access to a life-saving tuberculosis (TB) drug called Delamanid – one of the last drugs in the world’s arsenal against drug-resistant TB. These are patients who have stopped responding to most of the known TB drugs, and some of them have stopped responding to all TB drugs.
Living under the onslaught of the TB bacteria, all they could do was wait. That is set to change now – but only for a handful.
“We will get 400 courses of Delamanid within a month and patients will have access to it under the government’s conditional access programme (CAP),” Sunil Khaparde told The Wire on the sidelines of the TB symposium organised by the Family Welfare Training and Research Centre in Mumbai.
These 400 courses of Delamanid will go to patients in Punjab, Chandigarh, Rajasthan, Karnataka, Odisha, Kerala and Lakshadweep, across 21 centres under the government’s Revised National TB Control Programme. They will be free of cost to the patients. Globally, a six-month course of Delamanid costs $1,700 per patient (Rs Rs 1.16 lakh).
One-tenth of India’s drug resistant TB patients are in Mumbai, and they will not have access to Delamanid, nor will the patients in the private sector.
“The centres are spread across states which weren’t the first to get bedaquiline,” Khaparde told The Wire.
Indian has close to 2.8 million new TB cases every year. That means one in every fourth TB patient on the planet calls India home. Of this, nearly 2.8% of the people will not respond to most known TB drugs. Among the existing TB patients who have had a relapse, one in ten will not respond to most drugs.
Delamanid comes as a relief to this group of patients. However, the states with the highest drug-resistant TB burden have been kept out for now.
Maharashtra alone has over 8,000 patients with multi drug-resistant (MDR) TB, closely followed by Uttar Pradesh. Between the two, they have nearly 1,500 extremely drug resistant (XDR) TB patients. What’s worse, while these states have access to the drug bedaquiline, children with drug resistant TB and patients with HIV/TB co-infections don’t have any drugs. Bedaquiline is not suitable for these two groups as it is likely to do them more harm than good. And in its absence, they have no alternatives.
“Areas with the highest drug resistant TB burden should have access to the drugs,” said Syed Imran Farooq, country director for Challenge TB, a USAID-funded project that pushes for greater access to new drugs and regimens for patients.
Delamanid is the only drug that the WHO has approved for use in drug-resistant TB patients as young as six. The B.J. Wadia hospital for children in Mumbai, which has India’s only paediatric TB ward, will not have access to Delamanid.
‘Current drugs never tested’
“It is important to understand that the TB drugs that are currently used on thousands of drug resistant patients have never been clinically tested and have terrible side effects like permanent hearing loss,” explained Jennifer Furin, an infectious diseases specialist and medical anthropologist, Harvard Medical School. “After bedaquiline, Delamanid is only the second new TB drug in 50 years. It is both effective and a safe medication that can even be given to children,” she said, questioning the government’s rationale in restricting access to the drugs.
Most clinical trials don’t enroll children. As a result of this, when the drugs are out, it is difficult to know their effects on children. However, “the Delamanid trials involved children and there is data about the efficacy of the drug for the group,” Furin said.
India reports nearly 423,000 TB deaths every year – or one in three TB deaths in the world.
The US-based generic drugs manufacturer Mylan will be distributing Delamanid under an agreement with Japanese pharmaceutical corporations Otsuka in India. In a statement to The Wire, Mylan confirmed that they had initiated a technology transfer process with Otsuka so that, in the future, Delamanid could be manufactured in India. Mylan said it expects many paediatric cases to be in the 400-patient group who will get the drug.
“The first step is to have the drug in the country’s TB programme. But the delay is due to Otsuka. For years, despite holding a patent monopoly, it delayed filing the dossier for registration of the drug in India,” Leena Menghaney of Doctors Without Borders (MSF), an international organisation fighting for access to medicines for patients in the developing world, told The Wire. MSF has been providing a handful of patients access to both bedaquiline and Delamanid in India on compassionate grounds. The successful results were published in the journal Lancet in May this year.
When Otsuka did file to register the drug, it failed to include the paediatric indication. The government can approve the use of a drug only when a pharmaceutical company applies, which Otsuka delayed doing for years.
At the moment, the Indian government maintains that they are getting the drug as a loan from the Japanese government. “The terms have not been made public, so we don’t know the extent to which it will affect access to medicines,” Menghaney said.
Countries like South Africa, which also have a large number of drug-resistant TB cases, don’t just provide access but give their patients an oral dose of bedaquiline unlike – India where patients still have to take painful daily injections for as long as six months.
While India has committed itself to eliminating TB by 2025, this they will need to reduce the number of new cases by 15-20% every year to do this, by the government’s own admission.
Some drug resistant patients who will need both bedaquiline and Delamanid are also not going to be given the combination. “The whole system of restricted access makes no sense. 2025 is in seven years. Restricted use of innovation is certainly not a way to end TB,” Furin said.
Disha Shetty is a freelance science journalist.