TB related clinical trials permitted on children under one year

The approval was granted by the Central Licencing Authority.

The approval for clinical trials of various antibiotics on children under one years of age were mainly related to trials of Multi-Drug Resistant Tuberculosis and Tuberculosis Meningitis in children, parliament was informed on Tuesday. The approval was granted by the Central Licencing Authority and the details of the clinical trials are registered with Clinical Trial Registry of India, publicly available on In a written reply in the Rajya Sabha, Minister of State for Health and Family Welfare Faggan Singh Kulaste said that use of antibiotics is a major driver of resistance. "Neonates are more prone to infections and vulnerable to ineffective treatment. Sepsis remains a leading cause of mortality and morbidity, especially during the first five days of life and in low and middle-income countries," said Kulaste.

Antibiotics are included in Schedule H and H1 to the Drugs & Cosmetics Rules, 1945, and therefore cannot be sold in retail except on and in accordance with the prescription of a registered medical practitioner. Indian Council of Medical Research has launched a programme on Antimicrobial Stewardship, Prevention of Infection and Control in 2012. Functional infection control programmes not only cut down the rates of nosocomial infections, but also reduce the volume of antibiotic consumption and are a critical part of any comprehensive strategy to contain antimicrobial resistance.

"Further, a red line campaign has been launched to regulate over the counter sale of Schedule H antibiotics. The campaign is aimed at discouraging unnecessary prescription and over-the-counter sale of antibiotics causing drug resistance for several critical diseases including TB, malaria, urinary tract infection and even HIV," said Kulaste.

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Source: IANS

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