Business Daily from THE HINDU group of publications
Sunday, Sep 17, 2006
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Business Daily from THE HINDU group of publications Sunday, Sep 17, 2006 ePaper |
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Industry & Economy
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Health Corporate - Regulatory Bodies & Rulings DCGI approves drug for Kala-Azar Our Bureau
Fear factor The infection is transmitted by sand flies and causes chronic fever, weight loss and anaemia. Gland Pharma would make medicine available at approximately $10 per lifetime cure. Most affected State is Bihar. Hyderabad, Sept. 16 The Drug Controller-General of India has approved the drug for the treatment of visceral leishmaniasis (VL) or Kala Azar, the second most deadly parasitic disease in the world after malaria.
IM injection
The drug - Paromomycin intramuscular (IM) injection - was developed by the Hyderabad-based Gland Pharma Ltd in collaboration with the San Francisco-based OneWorld Health, a non-profit pharmaceutical company that develops medicines for neglected diseases of the developing world.
Systemic infection
VL or Kala-Azar is a systemic infection caused by various species of Leishmania parasites. The infection is transmitted by sand flies and causes chronic fever, weight loss and anaemia among others. Gland Pharma would make the medicine available at cost, or approximately $10 per lifetime cure, a significantly lower price than the currently approved VL therapies. The Gland Pharma General Manager, Corporate Finance, Mr Y.V.G. Krishna Rao, told Business Line that the Bill and Melinda Gates Foundation also supported the drug development programme. While VL currently occurs in 62 countries, primarily in the developing world, around 90 per cent of approximately 5 lakh new cases of VL are found in just five countries — India, Bangladesh, Nepal, Sudan and Brazil. Though the most affected State in India is Bihar, VL is also endemic in three other States - Jharkand, West Bengal and Uttar Pradesh.
KEY TOOL
The DCGI's approval of Paromomycin IM injection came less than three months after the submission of the drug's application, which was based on data from a large phase-III multi-centre, randomised and controlled clinical trial of 667 adult and paediatric patients conducted in Bihar, which showed that nearly all patients (94.6 per cent) treated with the drug were cured of VL. The drug is expected be a key tool for the country's National Vector Borne Disease Control Programme (NVBDCP), which aims to rid the country of VL by 2010. According to OneWorld Health, a 21-day course of the drug provides a safe, affordable, and effective cure for VL. It proposes to initiate a phase-IV pilot access programme in Bihar to facilitate the introduction of Paromomycin IM injection in these settings.
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