PIL seeks Bombay HC intervention for manufacturing MDR TB drugs

The Bombay high court on Wednesday asked the Centre to decide on the representations made by two multidrug-resistant tuberculosis (MDR-TB) survivors who have filed public interest litigation (PIL) seeking directions to the government to allow non-commercial production of two drugs Bedaquiline and Delamanid which are essential for the treatment of MDR-TB

The Bombay high court on Wednesday asked the Centre to decide on the representations made by two multidrug-resistant tuberculosis (MDR-TB) survivors who have filed public interest litigation (PIL) seeking directions to the government to allow non-commercial production of two drugs Bedaquiline and Delamanid which are essential for the treatment of MDR-TB. The PIL was filed as the drugs, patents of which are solely with the government, are not available regularly resulting in a break in the treatment regime for the near-fatal ailment. The petitioners have said that if the Centre authorises other manufacturers by giving them the patents, the shortage problem would be resolved.

Bombay high court

A division bench of chief justice Dipankar Datta and justice Girish Kulkarni, while hearing the PIL filed by Meera Yadav, an MDR and extensively drug-resistant TB (XDR TB) survivor and Jan Swasthya Abhiyan, an NGO run by another survivor was informed by senior advocate Anand Grover that after the World Health Organisation (WHO) had approved Bedaquiline and Delamanid as essential drugs for treating MDR and XDR TB, the patent for the medicines had been given to individual nations. After India got the patent, the same was given to two different pharmaceutical companies to undertake the manufacturing of the drugs.

As the cost of the drugs was high and generic drugs were not allowed to be imported, the companies were asked to give the drugs as donations to the government which in turn would be used to treat patients. However, due to the high number of patients in India which has forced India to declare an emergency the government has to procure the medicines at a high price as well. According to the petition, a six-month course of Bedaquiline costs around ₹26,600 and Delamanid costs up to ₹91,414 per course implying that the government would have to shell out huge amounts for the treatment of a single patient being treated under the Revised National Tuberculosis Control Programme (RNTCP) now known as the National Tuberculosis Elimination Program (NTEP).

Additional solicitor general Anil Singh for the central government informed the bench that the petitioners had already made representations to the concerned authorities and the same would be taken up expeditiously hence the PIL should be disposed of.

The court, however, observed that as the issue was of utmost importance as made out by the petitioners, it would keep the PIL pending and allow the Centre to decide on the representations which could then be placed before the bench for further consideration. Thus saying the court allowed the centre to respond after seven weeks and posted the hearing to April 28.