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A novel drug for the treatment of latent tuberculosis infection (LTBI) would soon hit Indian pharmacy shelves as the technical committee of the Central Drugs Standard Control Organisation (CDSCO) has cleared a proposal to import and sell the formulation without local clinical trial, it is learnt.
Refapentine, to be imported and marketed by Sanofi Synthelabo India, has been found effective in people two years of age and older at high risk of progression to tuberculosis (TB) disease.
With about 40 per cent of the Indian population infected with TB bacteria, LTBI treatment is an important component of the country’s disease elimination efforts, as the vast majority have latent infection rather than active TB. Rifapentine is included in the World Health Organisation (WHO) essential medicines list. The drug is reported to have the advantage of once-a-week regimen for three months, which increases its patient adherence.
In its application for approval to import the drug with local human trial waiver, Sanofi has submitted clinical trial data generated outside India in support of the medication. Cleared by the US Food and Drug Administration in 2014, the drug has since been approved in Taiwan, Hong Kong and the Philippines.
Last year, the company’s proposal was examined and approved by the CDSCO’s Subject Expert Committee (SEC) for antimicrobial and antiviral medications and forwarded it to the technical panel. After detailed deliberations, the technical committee has endorsed the SEC decision at its recent meeting. The minutes of the meeting have been reviewed by Pharmabiz.
During deliberations, the panel experts have noted that there is an unmet need of this drug for treatment of LTBI in the country at present. However, stringent conditions have been stipulated for marketing the new medication. The drug should be available only through the National TB Control Programme in the treatment of LTBI. The firm should conduct a Phase-IV clinical trial through the programme, for which protocol should be developed in consultation with the programme expert and submitted to the CDSCO for review through SEC.
Latent TB, caused by mycobacterium tuberculosis, occurs when patients have bacteria in their body in small numbers. They are kept under control by the immune system and won’t cause any symptoms. Without treatment, about 5 to 10 per cent of infected people will develop TB at some time in their lives and half of them will have the disease within the first two years of infection. High-risk groups include those in close contact with active tuberculosis patients, individuals with positive tuberculin skin test, HIV-infected people or those with pulmonary fibrosis on radiograph.
Though it has been a notifiable disease since 2012, the reporting of TB was not mandatory in the country. Last year, the Union health ministry criminalised non-reporting of TB cases to the government to get a more realistic picture of the disease’s incidence and prevalence. Failure to report TB cases now attracts the provisions of sections 269 and 270 of the Indian Penal Code. Moreover, India’s National Strategic Plan 2017-2025, a part of the Revised National Control Programme, aims at scaling up the number of people who are tested and successfully treated for TB, with a focus on active case finding.
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