Children with tuberculosis in India suffer on lack of proper fixed-dose combinations
Since 2010, evidence is emerging that doses to treat TB earlier thought to be optimal are less than what a child’s body needs, doctors say
New Delhi, May 11, 2016: Fixed-dose combination (FDC) drugs sold in India to treat tuberculosis (TB) in children do not contain the right amount of medicines, and the only one with the right combination made by an Indian company is not sold in the country, doctors at a meeting in Delhi said.
“None of the combination drugs available in India are correct for children. They contain lower amount of medicines than needed by young children suffering from tuberculosis,” said Varinder Singh, professor, paediatrics department, Lady Hardinge Medical College.
He was speaking at a roundtable on TB-free India, organized by the International Union Against Tuberculosis and Lung Diseases.
Since 2010, evidence is emerging that doses earlier thought to be optimal are less than what a child’s body needs.
“Earlier studies were conducted among older children and adults and were used to determine dose levels among young children. But in the past five to six years, many studies have been conducted among young children. It has been found that drug levels needed are higher than the adults,” said Singh.
The World Health Organization has also been advocating for increased amounts since 2010.
Four medicines are administered to children to treat TB. The amount of Isoniazid, commonly called the INH, thought to be optimal was 5 mg/kg weight of the child.
“We now recommend double of that amount. But the FDCs in India still follow older regime,” said Singh. Similarly, earlier 10 mg/kg of weight for antibiotic Rifampicin was recommended. But new science recommends it to be 12-15 mg/kg.
The recommended dosage for even Pyrazinamide, used exclusively to treat TB, has been increased from 25 mg/kg to 35 mg/kg.
There are no clear recommendations for Ethambatol, but it cannot be added to FDCs.
Results of such changes can be far-reaching, especially in case of children. FDCs are used to reduce the number of tablets one has to consume. In the absence of proper FDCs, paediatricians prescribe all medicines separately.
“FDCs increase adherence to TB regimen because the child has to take one or two tablets instead of four or more,” said Urvashi Singh, chief of tuberculosis section, Department of Microbiology, All India Institute of Medical Sciences.
Mumbai-based company Macleods Pharmaceuticals Ltd has produced an FDC according to new recommendations. It has been selling it to countries like Indonesia.
“Macleods has finally registered in India and should be selling the medicine soon in the country,” said Sunil D. Khaparde, deputy director general, Central TB Division of India of the health and family welfare ministry.
He said another Indian company Lupin Ltd has also applied for registration following the new recommendations.
Source: Livemint
