TWN Info Service on Intellectual Property Issues (Feb20/04)
17 February 2020
Third World Network

Kerala MP seeks PM’s intervention for domestic production of TB drugs bedaquiline & delamanid through compulsory license

Our Bureau, Mumbai
Monday, February 17, 2020, 08:00 Hrs  [IST]

A Member of Parliament from Kerala, TN Prathapan, has appealed to Prime Minister Narendra Modi to take immediate measures to initiate the domestic generic production of TB drugs bedaquiline and delamanid through compulsory license.

In a letter to PM, the Kerala MP urged him to direct the Union health ministry to initiate steps to include both bedaquiline and delamanid in the National list of essential medicines (NLEM) and to put an end to dependency on drug donation as given India is among the highest TB burden countries in the world, the quantities of bedaqmlme and delamanid donated to the RNTCP are grossly inadequate to treat the drug-resistant TB (DR-TB) population in India.

He asked the PM to take measures to initiate the domestic generic production bedaquiline and delamanid ether through a government use license under Section 100 of the Patents Act or a compulsory license under Section 92 of the Patents Act on patent nos. 236811 and 250365 covering life-saving drugs for DR-TB.

“This dependency on the donation is one of the important barriers in the scaling up of treatment. If the status quo remains, India will not achieve the target of ending TB by 2025 an announcement you made during the End TB Summit in March 2018. Given that India has a high burden of DR-TB, I request you to ensure that there should not be any unmet demand for these two new medicines and all people who require the treatment with these medicines are getting treated,” Prathapan in his letter the PM said.

In 2015, WHO has included two new drugs the treatment of DR-TB viz bedaquiline and delamanid in its Model List of Essential Medicines. Following which Central Drugs Standard Control Organization (CDSCO) approved access for MDRIXDR-TB through the Revised National Tuberculosis Control Program (RNTCP). Delamanid was also approved by CDSCO for children and adolescents with DR-TB aged 6 -17 years. However, these medicines are not part of our NLEM, the letter reads.

Based on WHO recommendations, RNTCP has been updating the Guidelines on Programmatic Management of Drug-Resistant TB (PMDT) and included the two new drugs in DR-TB regimens. It aims to phase out painful injections that can cause hearing loss. That bedaquiline and delamanid are important drugs for the treatment of MDRIXDR and there should not be any unmet demand on these medicines.

However, these medicines are under patent monopoly and therefore there is no generic availability of these lifesaving medicines in our country. Instead of taking steps to start the domestic generic production of these essential medicines RNTCP is depending on the donation, and charity pricing from the originator companies to treat patients, Prathapan in his letter said.

Given India is among the highest TB burden countries in the world, the quantities of bedaqmlme and delamanid donated to the RNTCP are grossly inadequate to treat the DR-TB population in India. According to the National TB Report 2019, only ‘2868 were initiated on a newer drug containing regimen; majority on bedaquiline while 41 on delamanid containing regimen". Unfortunately, a country taking pride in as the "pharmacy of the world" is depending on drug donation to treat its patients. This dependency on drug donation is also resulting in the denial of efficacious treatment and the right to health guaranteed under the constitution, he further said in the letter.

That more courses of bedaquiline and/or delamanid would be required with the increased availability of drug sensitivity testing (DST) of DR TB patients under the RNTCP programme. The absence of the required number of doses will result in poor scale-up of MDR/RR-TB treatment and risk of failure resistance. Once the donation programme is over, the government would have to purchase bedaquiline and delamanid at high prices, namely bedaquiline (priced at about INR 28,567/USD 400 for a six-month course) and delamanid (priced at about Rs. 1,21,413/USD 1,700 for a six-month course).

I am writing to request you to take urgent actions to scale up more effective injection-free treatment for DR TB, including life- threatening forms multi-drug resistant TB (MDR-TB) and Extensively drug-resistant TB (XDR-TB). According to WHO's Global TB Report of 2018 India accounts for 24% of global MDR TB cases and with a low treatment success rate for MDR-TB at less than 50%, the letter said.