4% malaria drugs substandard in India: Study

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SummaryThe study by the American Enterprise Institute took precautions to eliminate counterfeit products from among its samples.

A study published in the Malaria World Journal has found that worldwide 2.6 per cent of all WHO-approved artemisinin-based anti-malaria drugs are substandard, as they have less than the prescribed quantity of active ingredient. For India, the figure stands at 4 per cent while in China it is 12.3 per cent, the highest.

The study by the American Enterprise Institute took precautions to eliminate counterfeit products from among its samples.

Out of 1,203 artemisinin-based combination therapies (ACTs) examined in the study, 684 were produced by WHO-approved manufacturers and 519 by non-WHO approved ones. It said that 2.6 per cent (18/684) of the ACTs of WHO-approved manufacturers had insufficient active pharmaceutical ingredient (less than 75 per cent), while 12.5 per cent (65/519) of ACTs of non-approved manufacturers had too little active pharmaceutical ingredient, and were considered substandard.

Though the aim of the study was to ensure more effective utilisation of donor funds and it concluded that donors should emulate the practice of the US President’s Malaria Initiative of testing every batch of medicines sent out to foreign countries, for India the findings were medically significant given the high disease burden and the looming shadow of drug resistance. The three Indian cities from where drug samples were lifted were Delhi, Chennai and Kolkata.

“We use artemisinin as the second line of therapy as a large portion of malaria cases caused by the parasite, Plasmodium vivax, are resistant to chloroquine, which has been the first line drug. In fact, chloroquine resistant malaria is common in India so artemisinin-based therapies are often drugs of choice. We really have no option but to follow the WHO recommendations and approvals they grant to drugs blindly,” said Dr Mukesh Mehra, senior consultant at Max Superspeciality Hospital, Patparganj.

The artemisinin group of drugs are believed to be the most effective among the current crop of anti-malaria drugs in killing the protozoa, Plasmodium falciparum. However, in 2004 the World Health Organisation had banned artemisinin.

The present findings are significant because earlier this year a study published in The Lancet said that artemisinin-resistant malaria that had been found in Thailand is spreading towards India.

According to data given by the Health Ministry in Parliament, till November 2 there were 7,36,875 cases of malaria. India’s malaria burden remains a matter of debate as the Million Death Study puts the figure at 1.5-2 lakh deaths while the ministry maintains that the figure is in the range of

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