Bombay HC directs Centre to decide representation seeking ‘compulsory licenses’ to two patented anti-TB drugs

THE Bombay High Court Wednesday directed the Central Government to pass an order on a representation asking it for 'compulsory licenses' to import two patented life-saving anti TB drugs – Bedaquiline and Delamanid, – which offer fresh hope to MDR and XDR TB patients.

The decision is to be taken by the Centre by April 28, the court said.

The compulsory license once operationalised will allow alternate producers to offer more affordable generic versions of the drug to the National TB Elimination Programme (NTEP) at a far lower price.

The order came to be passed by a division bench of Chief Justice Dipankar Dutta and Justice Girish Kulkarni on a public interest litigation filed by TB survivor Mira Yadav and the Co-convener of Janswasthya Abhiyan (JSA), Brinelle D'Souza. D'Souza is also a TB survivor.

Senior advocate Anand Grover, for the petitioners, argued that India had the largest number of people affected by tuberculosis, and specifically by MDR-TB and XDR-TB. India, and particularly, Mumbai had a high burden of MDR-TB and XDR-TB.

He said if granted a compulsory license, generic companies can make drugs affordable and help India's goal to eradicate TB by 2025.

"Bedaquiline and delamanid need to be made available desperately and immediately as a part of the treatment protocol of the government program (NTEP) to treat people living with MDR and XDR TB to address this national health emergency. This can only be done effectively by issuing a government use compulsory license in accordance with the Patents Act, 1970 (Section 92 or Section 100) so that these drugs can be made available for public non commercial use to address the extreme urgency and national emergency relating to MDR/XDR TB", the plea said.

The plea said currently these drugs were patented – Bedaquiline by Janssen Pharmaceuticals, Inc. and Delamanid by Otsuka Pharmaceutical.

"Unfortunately, the Central Government is relying on donations by these two companies. These donations are a minuscule quantity compared to what is required. The government has not been able to procure these drugs as tenders have failed and they are being sold at high prices by Jenssen and Otsuka", Grover submitted.

These drugs have been recommended by the World Health Organization, the Subject Expert Committee of the Drugs Controller General of India (DCGI) has approved their use under programmatic conditions, and the NTEP includes them in the guidelines for the programmatic management of drug-resistant tuberculosis in India.

As the petitioners' representation to the government is pending, the court was of the opinion that the Central Government pass an order by April 28, after which the petition would be taken up.