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New laws on registration of dietary drugs

by Shanika Sriyananda Liyanage

Following the recent detection of some 'dietary supplements', which are not registered in Sri Lanka, the Ministry of Health, Nutrition and Welfare has appointed a committee to keep a tab on these items in a bid to implement new guidelines on their registration.

A team of Food and Drug Inspectors of the Drug Regulatory Authority (DRA) recently detected some consignments of these 'supplements' including glucosamine sulphate, anti-fat, anti-cholesterol and vitamin B with Enzyme syrup in the possession of a wholesale distributor in Dehiwala. Over 5670 bottles (100 ml.) of Enzyme syrup were among these items detected. It was in 'amaranth red' colour which was not approved in Sri Lanka.

The six-member committee, headed by Dr. Manil Fernando, Deputy Director-General of Health Services, comprises Dr. B.F.S. Samaranayake, Director, Medical Supplies, S. Nagiah, Chief Food and Drug Inspector, Dr. Janaka Munasinghe, Dr. Malani Piyasena, nutritionist from the Medical Research Institute, and B.S. Mendis.

The committee is expected to prepare a report within a month on the legal aspect of registering these items with the DRA. "There are over 100 such supplements in the local market which are not registered drugs or food items in Sri Lanka since they do not come under the drug items described in the Cosmetics, Devices and Drugs Act or the Food Act", P. Madarasinghe and Alwis Karunaratne, Food and Drug Inspectors of the DRA, who conducted the raid, said.

According to Madarasinghe, there is no restriction on the import of these items and anyone could easily get the clearance from the Customs Department. "There may be nutritional value in these supplements but their direct or indirect health hazards are still unclear. There is no particular authority on these items and no research on dietary supplements has ever been conducted here. This phenomena is a worldwide threat", said Madarasinghe.

He said that the alarming number of patients with kidney failure and cancer might be due to the avoidance of a 'balanced diet' and taking more dietary supplements.

"This needs a thorough study. Some ingredients in these supplements have true medicinal value but it is doubtful whether the manufacturer uses the required amount of the particular ingredient to get the real benefit", he added.

According to Madarasinghe, strict action should be taken to control these drugs reaching the country and their registration under the DRA, especially since there is a high demand for weight reducing supplements among the people.

HNB-Pathum Udanaya2002

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