New Delhi, 27 January 2017 — In a letter to the Ministry of Health, drug-resistant TB (DR-TB) survivors, networks of people living with HIV and public health organisations have called on the Government of India to incorporate the life-saving anti-TB drug delamanid into its Revised National Tuberculosis Control Programme (TB Programme). The letter states that to do this the government must direct Ostuka Pharmaceuticals Co. Ltd (Otsuka), the company that holds monopoly control over the drug to register delamanid in India without delay.
Quotes from representatives:
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.
- Paul Lhungdim, The 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.
- Anand Grover, Lawyers Collective
Patents are not granted merely to enable the patentee to enjoy a monopoly, but on the condition that the patent holder make the drug available in the country, yet more than eight years since delamanid was first granted a patent in India the drug is still not accessible to TB patients diagnosed with drug resistant strains. It’s beyond unacceptable to know that there are medicines out there that could offer hope to people with DR-TB who have exhausted all other treatment options, but that so few people have access to them. What’s the point of a new potentially life-saving treatment if the people who need it the most cannot access it?
- Leena Menghaney, Médecins Sans Frontières (MSF) Access Campaign
India has some of the highest prevalence of both drug-sensitive (DS-TB) and drug-resistant forms of TB (DR-TB), including multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB), in the world 1. 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.
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 the World Health Organization (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.
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.
1 Multidrug-resistant TB (MDR-TB) is defined as TB that is resistant to isoniazid and rifampicin, the two most powerful TB drugs. Extensively Drug-Resistant TB (XDR-TB) is resistant to at least four of the core anti-TB drugs which include – isoniazid, rifampicin, any of the fluoroquinolones (such as levofloxacin or moxifloxacin) and at least one of the three injectable second-line drugs (amikacin, capreomycin or kanamycin).
2 Bedaquiline was recently in the news when a case was brought before the Delhi High Court by the father of an XDR-TB patient who had been denied access to the drug because she was not a resident of Delhi. This came from the eligibility criteria for the Conditional Access Programme under, which bedaquiline is available, that restricted access to the drug to Delhi, Mumbai, Ahmedabad, Chennai or Guwahati - the five cities where the six centres rolling out the drug are located. In a landmark case the Delhi High Court passed an order clearly stating that residential proof/domicile is not necessary criteria to be able to access the life-saving drug. http://delhihighcourt.nic.in/dhcqrydisp_O.asp?pn=11539&yr=2017