New drugs still out of reach for most in India, hotbed of TB patients

Mumbai: The case of a Mumbai tailor cured of an extremely resistant form of tuberculosis this week has revived debate over a new drug to which the government has limited access, prompting calls for change. Dr Zarir Udwadia, the chest physician who treated the tailor, said the government needed to do a "a lot more" to control tuberculosis in India, home to the world's largest number of TB patients.

The government approved the drug bedaquiline in January for about 500 patients under a national TB control programme. It is intended for patients with an extremely resistant form of the infection and are immune to existing drugs. But it has no plans yet to make the drug available to the private sector, which is where more than half of the 3 million afflicted with the deadly infection go for treatment.

"They are starting with the pilot study (on bedaquiline), but you know what? Our plans can take forever. And till then, people are dying," Udwadia said.

Experts say the government is hesitant to allow the drug's wider use as a lack of supervision, incorrect diagnostics and mismanagement of drugs are commonplace in the private sector.

Such mismanagement can result in patients developing resistance, which Soumya Swaminathan, Director of India's National Institute for Research in Tuberculosis, said was a major risk. "The idea is to control the use of these new TB drugs, because there are very few of them," she said.

Swaminathan said that was why the government would introduce the drug to only about four to five public sector hospitals across the country and decide on expanding access after reviewing data from initial patients. That would, however, delay the drug's access for many.

India has about 100,000 drug-resistant TB patients. Udwadia procured bedaquiline, made by U.S. firm Johnson & Johnson Inc (JNJ.N), for his patient on "compassionate grounds," before the Indian government approved its use. Bedaquiline, the first new TB treatment in more than 40 years, got U.S. approval in 2012 for use on drug-resistant TB.

In 2013, the European Medicines Agency recommended conditional marketing approval for delamanid, another new treatment for multi drug-resistant TB by Japan's Otsuka (4578.T). Otsuka has not yet applied to the Indian regulator for approval.

Activists and NGOs, including the medical charity Medecins Sans Frontieres, have been campaigning for expanding access to these new TB drugs. Critics say India's national tuberculosis control program has failed to adequately address the country's disease burden. Fewer than half of the TB patients in India are treated successfully every year, according to the World Health Organisation.