Tuberculosis is without doubt a deadly disease that requires serious and constant attention. To address the growing incidence of drug-resistant tuberculosis, its survivors and various public health groups have written to the Department of Health for the incorporation of the patented drug Delamanid into the RNTCP(Revised National Tuberculosis Control Programme). Delamanid has been shown to be effective in the treatment of drug-resistant TB. In a letter to the Union Ministry of Health, the organizations urged the government to order Ostuka Pharmaceuticals Co. Ltd. (Otsuka), the company holding the drug monopoly, to register the delamanid in India without further delay.
People living with MDR and XDR-TB receive insufficient treatment in India, too often people die because they can not access the medication needed to make a proper treatment regimen for them. Otsuka has denied us access to the new anti-tuberculosis drug delamanid for a very long time. We urge the Indian government to order the company to register the drug and ensure it is provided to the TB control program. If the pharmaceutical company does not make the drug available in the country, the Department of Health should look for generic suppliers for government purposes. This will save thousands of lives.
Two new drugs to be developed for tuberculosis in nearly 50 years, bedaquiline (marketed by Janssen / J & J) and delamanid (marketed by Otsuka). Both drugs have shown great potential for dramatically improving treatment outcomes and have been recommended by WHO, including those with M / XDR-TB, particularly for patients for whom other factors - HIV infection) with current DR-TB treatment regimens. However, since both drugs are patented in many countries with high TB burden such as India, Otsuka and J & J enjoy monopoly control over the supply and pricing of these rescue medications.
Currently, India has barely enough Bedaquiline to treat about 300 patients. The cache was acquired as part of a USAID donation program and distributed by five centers as part of the TB program. Delamanide has yet to be incorporated into the program although the drug was patented more than eight years ago.
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
