Bharat Immunologicals and Biologicals Corporation Ltd (BIBCOL), a public sector undertaking under the Department of Biotechnology, will produce zinc dispersible tablets for treatment of diarrhoea in infants and children, with technology developed by a French company and transferred through WHO.
BIBCOL is ready with GMP facility for the production of the tablets to be used in a big way under the National Rural Health Mission in children below five years. The product was developed with technology transfer from Nutriset (French company) through Department of Biotechnology. The Nutriset product has been tested in Indian fields and clinical trials have evaluated the efficacy of zinc supplementation and safety, DBT sources said.
Zinc, as an immunomodulator agent, has been considered as a novel treatment for childhood infection particularly, childhood diarrhoea, pneumonia and septicaemia. In India alone, more than 500,000 deaths occur annually due to childhood diarrhoea. The use of zinc along with oral rehydration therapy (ORT) is recommended by WHO to decrease the incidence and severity of diarrhoea and the Centre had decided to use this simple, easily dispersible and cheap zinc tablets for the national programme.
``Zinc Dispersible tablets, to be given for management of diarrhoea in children aged two months to five years would provide children with 20 mg of elemental zinc supplementation per day for 10-14 days (10 mg per day for infants less than six months of age). Zinc Dispersible tablets become syrup after adding breast milk or water. The treatment should be started from the first day of diarrhoea itself and a 14-day course should be completed even if diarrhoea stops. The tablet is not only effective in stopping diarrhoea but also prevents subsequent illness,'' a DBT official said.
The dispersible zinc tablet, BIBZinc-20mg, contains 20 mg of elemental zinc as active ingredient and contains sweetener and taste masker (Vanilla flavour) and is scored tablet. The product is in line with the recommendations of WHO. BIBCOL is ready with tablet manufacturing facility and trial batch has been produced. The company has a production capacity of 240 million tablets per annum and will soon come with commercial production.
The profit-making BIBCOL, based in Bulandshahar district of UP, manufactures Oral Polio Vaccine (OPV) and other immunobiologicals. It has been formulating OPV from imported bulk since January 1996 and about 1000 million doses have been supplied to the national immunization programme.