Congress MP seeks domestic production of generic drugs to treat TB

There is an urgent need to start domestic production of generic medicines required to treat drug-resistant tuberculosis (TB), Congress MP T.N. Prathapan demanded in a letter to Prime Minister Narendra Modi on Friday.

Mr Prathapan’s letter comes in the backdrop of ongoing negotiations to frame the India-U.S. trade agreement. The Patents Act that allows compulsory licensing of a specified drug is a major point of friction in the negotiations. This provision can also be used to override international patents.

U.S. Trade Representative Robert Lighthizer, who was expected to be in New Delhi on Thursday, put off his trip to India amid signs that trade talks have hit a rough patch, just ahead of U.S. President Donald Trump’s visit.

The World Health Organisation in 2015 introduced bedaquiline and delamanid for the treatment of drug-resistant TB. These medicines are currently under patent monopoly. “Instead of taking steps to start the domestic generic production of these essential medicines, the Revised National Tuberculosis Control Programme (RNTCP) is depending on donation and charity pricing from the originator companies to treat patients,” Mr. Prathapan said.

According to WHO’s Global TB Report of 2018, India accounts for 24% of global “multi-drug resistant” TB cases. As per the World Trade Organization agreement, a compulsory license can be invoked by a national government to allow someone else to produce a patented product or process without the consent of the patent owner, when it is done for the cause of public health.

“The dependency on 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,” Mr. Prathapan stated. He made three demands: first, the two medicines be made available to all patients of drug-resistant TB; second, the medicines be a part of the national list of essential medicines, and third, to put an end to dependency on drug donation and initiate their domestic generic production.

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