Medical history analysis of a patient being treated at the Nizam’s Institute of Medical Sciences (NIMS) in the city for a rare neuromuscular disorder pointed fingers at a natural health food the individual had consumed for extended time.
As manufacturer’s data of substance was not available, the treating physician was forced to seek testing of the substance, indicating the need for enforcing newly introduced food safety guidelines.
Food safety experts say demands for testing are on the rise, concomitant with the growth of the nutraceutical industry which was pegged at an estimated at $ 2.8 billion in India by Associated Chambers of Commerce and Industry and is expected to touch $ 6.1 billion. Nutraceuticals include dietary supplements, beverages like energy drinks and functional foods like fortified foods.
The Food Safety and Standards Authority of India (FSSAI) published its revised guidelines for proprietary foods, which includes nutraceuticals. The guidelines placed the onus of responsibility for food safety on manufacturer but lack of vigilance and monitoring system helps manufacturers get away, says Dinesh Kumar, president of Indian Pharmacological Association and Senior Scientist at the National Institute of Nutrition (NIN).
Pharmacological vigilance
“In the past five years, efforts have been stepped up to popularise pharmacological vigilance. However, adverse events from herbal and health foods have been beyond question as in many cases the labels with information on constituents are simply not available on the product. Therefore, the need for nutraceutical vigilance,” Dr. Kumar says.
According to Dr. Kumar, substances tested in the past have contained components, including vitamins and minerals, far exceeding required doses. He added that such foods, prescribed popularly for obesity and other lifestyle disorders besides improving general living, are now also being linked to disorders being reported from across the country with unexplained causes.
To enforce the newly formulated guidelines, the Ministry of Health and Family Welfare designated NIN has set up a monitoring centre for nutraceutical safety assessment under the Pharmacovigilance Programme of India.
Awareness programme
The institute will soon take up awareness programmes to convey to its consumers and physicians that they can report adverse events and suspicions at the institute. This in turn, is aimed at developing a database of such events that will help develop guidelines for safe use of such products.
