Doctors still looking for the Correct FDCs for TB medication for children in India

New Delhi: Treatment of Tuberculosis among children in India seems to be falling short on strength of dose administered to child patients, according to doctors attending a meeting in Delhi. The World Health Organization (WHO) has been advising increased dosage for the TB child since 2010.

Isoniazid, commonly called the INH, thought to be optimal as 5 mg/kg weight of the TB child has now been doubled; making it 10mg/kg weight. Similarly, antibiotic Rifampicin, earlier recommended at 10 mg/kg of weight has been risen to 12-15 mg/kg.

Pyrazinamide, an exclusively TB treatment dose, has been increased from 25 mg/kg to 35 mg/kg. Results of such changes can be far-reaching, especially in case of children.

On Ethambatol, there are no clear recommendations; however, it cannot be added to FDCs.

However, despite the increased recommended of dosage in some of the above TB medicines, the fixed dose combinations (FDC) drugs for treatment of Tuberculosis (TB) among children still stand with the old order of prescription. The one drug which has the right dosage combination is absent in India. Manufactured by Mumbai-based Company, Macleods Pharmaceuticals Ltd, the FDC drug, set according to new recommendation, is selling only in Indonesia.

FDCs are meant to decrease the no of tablets to be consumed by a TB ridden child; however, in the absence of appropriate strength FDC drugs, pediatricians continue to prescribe medicines separately.

“None of the combination drugs available in India are correct for TB afflicted children. They contain lower amount of medicines than needed by young children suffering from tuberculosis,” said Varinder Singh, Professor, Pediatrics Department, Lady Harding Medical College, while attending a roundtable on TB Free India, organized by the International Union Against Tuberculosis and Lung Diseases.

Since 2010, emerging evidence proves 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.

“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 Tuberculosis Section, Department of Microbiology, All India Institute of Medical Sciences.

A saving grace in today’s scenario on TB drugs is that Macleod has now registered in India and will soon be selling their right composition FDC drug inIndia, reported livemint.

“Macleod 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, naming Indian company Lupin Ltd as the other major company to have applied for registration following the new recommendations.