Indian government promises paediatric formulations of TB drugs

BMJ 2012; 345 doi: (Published 17 December 2012) Cite this as: BMJ 2012;345:e8563
  1. Mohuya Chaudhuri
  1. 1New Delhi

The Indian government has approved a new protocol for treating paediatric tuberculosis and has said that it would procure specially formulated drugs suitable for children.

Ashok Kumar, deputy director general for tuberculosis at the Ministry of Health and Family Welfare, said that a consultation was held to revise the protocols for treatment of tuberculosis in children eight years ago but that the decision to revise the guidelines was taken only this year.

Kumar said that the new protocol had increased the number of weight bands from four to six to suit more children. The government has also approved dispersible formulations of drugs to make them easier for children to swallow. New formulations would be available next year, he said.

Many commentators hope that the steps will help reduce the burden of paediatric tuberculosis in India. Although the government’s 1993 revised national control programme significantly improved access to treatment, many children fall through the gap.

The World Health Organization has estimated that in India each year 200 000 children receive a diagnosis of tuberculosis but that only 50 000 are treated. With two million new cases every year overall, India has among the largest burdens of the disease in the world.

There are several challenges to managing tuberculosis in children. It is more difficult to detect in children than in adults, and bacteria can spread rapidly, infecting other organs. Because treatment is carried out at directly observed treatment short course (DOTS) centres, and these can be some distance from where families live, many children are simply not treated. Many of those children who are treated are given inadequate doses, because the paediatric formulations of antituberculosis drugs are not suitable for their weight, increasing resistance to the drugs.

Shibu Vijayan, from Global Health Advocates, an organisation that helps fight diseases that affect poor people, said that the standard practice, based on the previous guidelines, to crush adult tablets for children and dissolve them in water or food had significant potential to deliver incorrect and highly variable doses.

It was to deal with such issues that a consortium of organisations, including the Indian Association of Paediatrics, the Indian Medical Association, and the International Union Against Tuberculosis and Lung Disease, has worked with the government to provide child friendly formulations such as suspensions, syrups, and dispersible tablets. Currently these are not available in India.

Ashish Mungantiwar, vice president of Macleods Pharmaceuticals, said that on the recommendations of the World Health Organization companies were developing new dosage formulations that were more effective in treating tuberculosis in children. He said that because children had a fast metabolism they may need higher doses than had been used in the past.


Cite this as: BMJ 2012;345:e8563