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Indian Journal of Pharmacology, Vol. 38, No. 6, November-December, 2006, pp. 439-441 Correspondence Are ORS brands in India using the name of WHO judiciously? Bachewar N, Thawani V, Gharpure K Department of Pharmacology, Government Medical College, Nagpur - 440 003 Code Number: ph06128 Diarrhea is the passage of loose, liquid or watery stools. In diarrhea, the change in consistency and character of stools are more important than the frequency of stools.[1] The World Health Organisation (WHO) and UNICEF define acute diarrhea as an attack of a sudden nature that usually lasts 3-7 days, but may last 10-14 days. When blood is present in stools, it is called dysentery. The WHO initiated the diarrheal disease control program in 1980 when approximately 4.6 million children were dying each year of dehydration caused by diarrhea.[1] In 2000, there were about 21.25 lakh deaths and 59.7 million DALYs (Disease associated life years) lost due to diarrhea.[1] Thus diarrhea continues to be a major health concern in developing countries, including India. Introduction of oral rehydration by WHO in 1969 simplified the treatment of diarrheal diseases.[2] Oral rehydration salts (ORS) were reported to treat 90-95% of acute diarrheal diseases.[1] The composition of ORS recommended by WHO,[2] in 1969 was as follows: Sodium chloride 3.5 g In 1984, to increase the stability of ORS solution and to decrease the stool output, sodium bicarbonate was replaced by 2.9 g trisodium citrate dehydrate.[2] It was suggested that the composition of ORS should be changed according to the loss of electrolytes. Except for adult cholera, in other conditions, like cholera in children, enterotoxigenic E. coli and rotavirus infection, the Na+ loss is less than 90 mMol/l.[2] Hence, if these conditions are treated with the older ORS formula, there is a chance of development of hypernatremia with replacement of 4-5 l of body fluids. Therefore in 2002, WHO and UNICEF recommended an improved ORS formula with lesser Na+ and glucose, as a result of which the total osmolality is far less than the previous formula.[2] The comparison of the old and new formula is shown in [Table - 1]. - lower osmolality allows quicker absorption of fluids, The WHO and UNICEF recommend nations produce of the new ORS [2] with WHO providing the updated international quality specifications for the new formula and UNICEF the leading supplier of ORS to economically poor countries. The new formula was expected to have lowered price by 15% due to decreased quantity of ingredients. The Indian scenario In India, ORS is available free of cost in government hospitals. Various pharmaceutical companies manufacture ORS for sale in the market. During a field exercise in March 2006 at Saoner village of Nagpur district of Maharashtra state in India, the participants of the WHO sponsored and funded "Training course on rational use of medicines in community" collected data for those formulations in the market which contained the WHO name and/or the WHO/UNICEF ORS logo. Their findings are presented in [Table - 2]. Most of the branded ORS formulations with WHO name/logo have added flavors of orange or lemon, which WHO considers as unnecessary. The logo "WHO recommended formula" is not clearly readable in most brands. Some have printed it as "WHO formula". One company has mentioned it as "new formula" whereas the contents are of the old one. Some companies are manufacturing smaller pouches to be dissolved in 200 ml of water, which may not be correctly diluted thereby affecting the final osmolality. The font size of WHO on one brand is so large that it looks like brand promotion with the name of WHO. While the company supplying the ORS to the government has carried the name of WHO in small font size, it is worth probing why others do not follow the same practice. Due to the confusion in ORS concentrations available in the market, even the literate feel confused in identifying the one recommended by WHO, the composition that is correct and the latest, and also as to whether WHO recommends the orange / lemon flavors of ORS that are available in the market. The prescribers routinely advice the patients to dissolve the whole ORS pouch in 1litre water and if the patient buys a smaller pouch, the end result can well be imagined. Paragraph 28 of WHO Criteria for Medicinal Drug Promotion, which concerns packaging and labeling reads that " Appropriate information being important to ensure the rational use of drugs, all packaging and labeling material should provide information consistent with that approved by the country's drug regulatory authority. Where one does not exist or is rudimentary, such material should provide information consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Any wording and illustration on the package and label should conform to the principles of ethical criteria enunciated in this document".[3] This brings up questions as to whether all that which is being practiced by ORS brands in India is ethical. The lack of importance given to medicine promotion in medical and pharmacy education stands in stark contrast to the huge medicine promotion being practiced, and the body of empirical evidence indicates that promotion affects behaviors, health care quality and costs.[4] Hence it is desired that there be some monitoring mechanism in WHO to check whether its name and logo are being used in concurrence with its policies and recommendations. Let not the pharmaceutical industry exploit the opportunities for promoting their branded products, and get away with it. We may be wrong in our interpretation but if the watchdogs are barking, the master needs to have a look at what the noise is all about. References
Copyright 2006 - Indian Journal of Pharmacology The following images related to this document are available:Photo images[ph06128t2.jpg] [ph06128t1.jpg] |
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