Even as the country is facing the highest prevalence of both drug-sensitive (DS-TB) and drug-resistant forms of TB (DR-TB) in the world, a large number of NGOs including the DR-TB survivors, networks of people living with HIV and public health organisations have called upon the Union government to incorporate the life-saving anti-TB drug delamanid into its Revised National Tuberculosis Control Programme (TB Programme).  

In a letter to the Union Ministry of Health, these organisations have urged the government to direct Ostuka Pharmaceuticals Co. Ltd (Otsuka), the company that holds monopoly control over the drug, to register delamanid in India without further delay.

A demand in this regard by the public health organizations is significant as India has some of the highest prevalence of both DS-TB and DR-TB, including multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB), in the world.  In most cases, DR-TB patients face a minimum of nine months of treatment, usually closer to two years, during which they must swallow more than 10,000 pills in addition to six to eight months of painful injections. Side effects caused by the drugs are horrendous, ranging from persistent nausea to deafness and psychosis.

These organisations argue that there is a desperate need for new drugs to improve not just treatment outcomes but also to provide safer alternatives to the most toxic DR-TB drugs. Today there is reason for hope with the first two new drugs to be developed for TB in nearly fifty years, bedaquiline (marketed by Janssen / J&J) and delamanid (marketed by Otsuka). Both of these drugs have shown strong potential to vastly improve treatment outcomes and have been recommended by WHO, including those with M/XDR-TB, particularly for patients for whom other factors (such as co-infection with HIV) increase their risk of poor outcome with current DR-TB treatment regimens. However, as both drugs are patented in many high-burden TB countries such as India, Otsuka and J&J enjoy monopoly control over the supply and pricing of these lifesaving drugs.

They further add that the TB programme and patients with M/XDR TB need urgent access to the new TB drugs to improve cure rates and treatment outcomes. The impact of introducing the new drugs to the regimens of old TB drugs currently available under the TB Programme’s Programmatic Management of Drug Resistant TB (PMDT) will reduce suffering and increase survival rates for patients diagnosed with M/XDR TB. The effect of introductions of two new drugs would also have substantial public health effects in reducing transmission of M/XDR TB.

Bedaquiline has been registered in India for use in the TB Programme and the Ministry of Health has accepted delivery of 300 treatments under a USAID donation programme. The drug is strictly regulated and is being rolled out through six centres as per eligibility criteria laid down in the PMDT guidelines. The TB Programme is yet to incorporate delamanid in the PMDT guidelines as the drug is not registered in the country. This is despite the fact that delamanid was patented as far back as 2008, as Otsuka continues to delay making the drug available to the TB programme and has made no request for regulatory approval.

People living with MDR and XDR-TB are receiving inadequate treatment in India, all too often people die as they can’t access the medication needed to compose a suitable treatment regimen for them. Otsuka has denied us access to the new anti TB drug delamanid for a really long time. We urge the Indian government to direct the company to register the drug and to ensure that it is supplied to the TB Programme. If the pharmaceutical corporation does not make the drug available in the country, the Ministry of Health should proceed to find generic suppliers for government use. Doing so will save many thousands of lives, said  Paul Lhungdim, Delhi Network of Positive People.

The recent court case before the Delhi High Court highlights the urgent need for newer TB drugs to be made accessible to patients with M/XDR-TB, as a matter of right. Delamanid is a critical new medicine to manage M/XDR-TB especially for younger patients and its non-availability is unacceptable. It is high time that both the Japanese pharmaceutical corporation Otsuka and the concerned government health authorities prioritise access to it to the public in need, and promote rational use of anti TB drugs, Dr. Gopal Dabade, All India Drug Action Network

Otsuka Pharmaceuticals has not initiated the process of making delamanid available in the Indian market. Not working the patents on delamanid is adversely affecting people living with MDR and XDR-TB. The government should intervene and direct Otsuka to provide the drug under the RNTCP, said Anand Grover, Lawyers Collective.