Health Ministry dragged to court over curbs on TB drugs

MUMBAI: Kaushal Kumar Tripathi, a government employee from Gaya in Bihar has been making the rounds of New Delhi’s Lal Ram Swarup TB (LRS) hospital to get hold of the new tuberculosis (TB) drugs which is his last hope of saving his 18-year-old daughter suffering from Extensively Drug Resistant (XDR) TB.

The drugs –– Bedaquiline by US drugmaker J&J and Delamanid by Japanese drugmaker Otsuka Pharma –– are the only treatment option for patients like Tripathi’s daughter. However, it is not available in private markets and it is only through a donation programme that both companies have agreed to supply these drugs to Indian patients. According to the Condition Access programme signed with J&J, the health ministry will procure 600 doses of Bedaquiline, which was the first TB drug approved by USFDA after 40 years.

However, there are stringent restrictions which make the drugs out of reach of ordinary patients. For one, it will be available only at the six TB centres of Delhi, Chennai, Mumbai, Guwahati and Gujarat.

Government guidelines indicate that patients who do not belong to these cities cannot access the drug. “After making several visits to LRS hospital, my daughter was refused treatment because she is not from Delhi,” Kaushal Kumar told ET. Tripathi has filed a writ petition against the health ministry, asking it to ensure easier access to these drugs. The petition, which will come up for hearing at the Delhi High Court on Monday, has also made the LRS hospital a party to this case. Tripathi is represented by Anand Grover of Lawyers Collective.

“My petition has asked the government to ensure access to these TB drugs to patients like my daughter,” he said.

Tripathi said the health ministry must be responsible for ensuring access to both these drugs which the companies have offered to middle and low income countries for use on compassionate grounds.

However, in India, despite receiving patent for the drug, Otsuka has not registered the drug with the regulatory agencies, without which the drug cannot be made available here.A report by aid organisation ‘Doctors without Borders’ found that only 2% of the 1,50,000 patients have access to these new drugs as pricing and limited availability have kept the drugs out of the reach of needy patients.