Diseases - Breakthrough in TB Control (the Tribune-7 June 2010)

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    National Documentation Centre (NDC)

    Tuberculosis

    Breakthrough in TB control (The Tribune:7 June 2010)

    Indian scientists new drug cuts treatment span by half, ups efficiency hugely

    The story so far

    Currently, TB patients are given a two-drug (Rifampicin/Isoniazid) combination. Its not that effective asthese twin drugs react in patients stomach, neutralising each others efficacy. In tropical climate (like

    India), the treatment takes longer duration, allowing pathogenic bacteria to develop immunity to drugs.

    This is the primary cause behind poor progress of TB Control Programme.

    The new discovery

    The path-breaking new drug formulation (single capsule) compartmentalises the two drugs so they dontmeet in patients body. The drug will be especially effective in tackling the resistant strains.

    Why it is important?

    India has the highest TB mortality in world4 lakh deaths annually. Drug-resistant variants are major

    global concern. TB last year infected 9.2 million, mainly in Asia and Africa. Five per cent cases multi-

    drug resistant; 10 per cent extreme drug resistant.

    Indian scientists have achieved a major technological breakthrough in the treatment of Tuberculosis (TB)that is responsible for one death every minute in the country. India has the highest TB mortality in the

    world, with annually over four lakh citizens succumbing to the bacterial infection, which primarily affects

    the lungs.

    The new technology developed and patented by BV Patel Pharmaceutical Education and Research

    Development (PERD) Centre, Gujarat (the mentoring institute for National Institute of Pharmaceutical

    Education and Research (NIPER) Ahmedabad), promises, for the first time in 14 years, a solution to drug-

    resistant TB that is hampering the National TB Control programme. Drug resistance to TB pathogens is a

    global challenge now, with TB returning to the developed world as an opportunistic infection with HIV.

    The new anti-TB drug formulation (single capsule) can enhance treatment efficiency by 30 per cent andreduce TB treatment period by half --- from six months (sometimes a year and beyond) to three months. It

    does away with gross treatment inefficacies witnessed in the presently marketed fixed dose two-drug

    combination of Rifampicin and Isoniazid being administered to TB patients.

    The current combination is ineffective because Rifampicin and Isoniazid chemically react in the patientsstomach and neutralise each other, Dr Harish Padh, Director, PERD and Project Director, NIPER,

    Gujarat today told The Tribune.

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    The general loss of Rifampicins efficacy is 30 per cent and more in tropical climates because of which

    treatment remains sub-optimal and takes longer time, allowing pathogenic bacteria to develop immunity

    to drugs. This is the primary cause behind poor progress of TB Control Programme, he added.

    The new compartmentalised formulation to separate the two TB drugs in the capsule has been developed

    by a team led by Dr CJ Shishoo, Honorary Director, PERD Centre.

    The path-breaking technology works by segregating Rifampicin and Isoniazid in the capsule and thepatients body. In the new formulation, the two drugs dont see each other and therefore dont react,enhancing treatment efficacy by 30 per cent and reducing treatment period to three months. It should

    work for all types of TB though it is being tested for pulmonary TB, Dr Padh said.

    With new tools, the scientists ensure that Rifampicin tablet, in the discovered formulation, is retained in

    the stomach for six hours before being absorbed from the stomach. Isoniazid, meanwhile, is

    technologically prevented (though enteric coating) from dissolving in the stomach. It goes past the

    stomach and dissolves only on reaching the alkaline atmosphere of intestines. This solves the old

    problem, explains Padh.

    Funded by the Department of Biotechnology and Union Ministry of Chemicals, the project is at an

    advanced stage of trials, with animal and healthy human trials over. The AIIMS and PERD Centre have

    now decided to commence final comparative trials --- with old and new drug formulations --- on TB

    patients. Once evidence from comparative data is available, the government can go for production scale

    up of new technology.