Photo Credit: Lana Abramova
India has the highest burden of drug-resistant TB in the world with close to 1,00,000 suspected cases. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are on the rise, and access to new antibiotics will play a key role in developing new TB regimens to address growing treatment needs and improve cure rates.
Delamanid is a new antibiotic which has been included in the World Health Organization’s (WHO) treatment guidelines since 2014. A recent study showed that up to two thirds of MDR-TB patients are likely to benefit from the new drugs, especially delamanid. Patients with an even more severe form of the disease, extensively drug-resistant TB (XDR–TB) – in desperate need of more effective drugs – need delamanid to be added to their treatment regimens.
To date, however, few 100 patients worldwide have obtained access to this drug.
The company marketing delamanid, Otsuka Pharmaceutical Ltd., has neither filed for marketing approval in India, nor is it conducting phase III trials in India, which would provide crucially important evidence about the practicalities of using delamanid alongside other anti-TB drugs.
Without local clinical trials and marketing approval, delamanid cannot be procured by the national TB programme, or other treatment providers, to treat people with the deadliest, most drug-resistant forms of the disease.
In India’s pre-2005 patent system, if a company did not bring a new drug to India, companies could step in to register the new drug in India and start supply of generic versions. Today, with product patents being granted, this cannot be done easily.
The compound patent on delamanid has been granted in India to the Japanese company Otsuka Pharmaceutical Ltd. and is set to expire only in 2023.
More than three years have passed since the grant of the patent in India, and the working statement (Form 27) submitted by Otsuka to the Indian patent office reveals a startling fact: the patented medicine is neither being imported, nor has the company issued any licence to a generic manufacturer to supply the medicine to the National TB programme in India, or other developing countries for that matter.
Production of affordable generic versions of delamanid is blocked by patents, leaving Otsuka as the sole supplier of the medicine. According to the Indian Patent Act, patents are not granted “merely to enable patentees to enjoy a monopoly on a patented medicine”, and the patent holder must make the drug affordable and accessible to patients. Therefore, the government must take the necessary steps to ensure that this life-saving medicine becomes available to the National TB programme.