Experts, activists seek new regime for its rational use
Soon a new drug that can fight even drug-resistant tuberculosis (TB) is likely to be available to patients in India. The new drug, bedaquiline, was approved by the US Food and Drug Administration (FDA) a few days ago. As news spread of the approval being granted, health activists demanded a new mechanism to distribute the drug properly and avoid resistance to it.
Professor at Mcgill University in Montreal, Madhukar Pai, said that TB desperately needs new drugs, but at the same time, if new TB drugs are misused, their use could rapidly be lost to drug resistance. The Indian TB drug market is unregulated at present. Unless new drugs are used in rational drug regimens, it will be worrisome to introduce new TB drugs, he said.
Director of National Institute for Research in Tuberculosis in Chennai, Soumya Swaminathan, said, “The new drug will be very useful for treatment of patients with multi- and extensively-drug resistant TB, where the available options are not wide. However, the drug has been studied on a limited number of patients and its toxicity profile is still to be understood clearly. It will now enter phase III trials, which will bring more information.”
With FDA approval, the drug may become available in India and other countries, but its use needs to be tightly controlled for two reasons, said Swaminathan. “First, its widespread use and misuse will result in resistance developing to this new drug class also; second, its safety needs further study (some cardiac toxicity has been reported) and so it should be given to patients under close monitoring and expert supervision.”
Vice–chairperson of Global Stop TB Partnership and TB activist in India, Blessina Kumar, emphasised the need for proper mechanism for distribution of the new drug in India. US FDA granted accelerated approval for SIRTURO™ (bedaquiline) as a part of combination therapy to treat adults with pulmonary multi-drug resistant tuberculosis on December 31, but it is not known when would it be available in the country, she said. A proper mechanism is required for its distribution; keeping the drug safe while making it available to the needy patients, otherwise we will run the risk of drug resistance, she added.
The Revised National TB Control Programme (RNTCP) has now issued a directive to curb over the counter sale of anti-TB drugs which is a positive move and it is hoped that such measures will continue in addressing the huge problem of drug resistant TB in India.
Médecins Sans Frontières (MSF) also welcomed the approval of bedaquiline, the first new drug active against tuberculosis (TB) to be registered since 1963. In her statement, Leena Menghaney from MSF India said that India has the second highest multi-drug-resistant (MDR) TB burden in the world with nearly 66,000 new cases every year. This new drug comes at a time when drug-resistant tuberculosis (DR-TB) patients desperately need more options.
The current treatment of DR-TB relies on old antibiotics, many of which have severe side effects, ranging from constant nausea, deafness and psychosis. Patients must receive six months of painful injections and take up to 17 pills every day for up to two years.
She further said that the Indian health ministry, RNTCP and drug regulatory authority (DRA) need to put in the necessary regulatory framework to ensure that DR TB patients left with few options can benefit from new TB drugs like bedaquiline. At the same time DRA should prevent indiscriminate use of new TB drugs by the private sector to preserve their efficacy and prevent development of resistance.
In the past, indiscriminate use of TB drugs in the private sector and the inconsistent and poor management of TB treatment have led to drug resistance in the country with DR-TB acquiring the shape of a serious public health challenge in India.