Pharmabiz
 

A LAW FOR NUTRACEUTICALS

P A FrancisWednesday, October 15, 2003, 08:00 Hrs  [IST]

The First Nutraceutical Summit, concluded last week in Mumbai, has brought out some critical issues bothering this nascent industry in India. The objective of the summit was to crystallize proposals to be submitted to the government while framing a regulatory system for this emerging sector. Currently no clear cut regulatory framework exists for nutraceuticals and the sector is governed by three separate laws namely Prevention of Food Adulteration Act, Food Products order and Drugs and Cosmetics Act.In the summit, every participant, therefore, rightly felt the need for a regulatory system in place for this sector. But when it came to the specific regulatory procedures to be suggested, most of the participants did not want even standard rules ensuring safety and efficacy of these products to be adopted. They wanted least possible regulatory interventions in key administrative areas. For instance, most participants were against conducting clinical trials in India for new ingredients used in nutraceuticals if the documentary support is submitted to the regulatory authorities. A second conclusion is that the permissions to market combinations of approved ingredients to be granted without clinical trials if the manufacturers can provide substantiation data. Most participants have opposed the suggestion to provide package inserts carrying consumer information about nutraceuticals. The participants also strongly opposed another suggestion seeking a ban on all forms of advertisements about nutraceuticals in the media. And the worst suggestion came from a leading Indian pharma company seeking to allow manufacturing of nutraceuticals in the same facilities where allopathic drugs are manufactured. Many opposed the idea but the company prevailed upon the organizers to include it part of the suggestions from the Summit. In short, the general mood of the participants was to have a regulatory system for the sector with no teeth. The concern for consumer safety or product efficacy was totally absent at the meet. Dr S P Adeshara, Commissioner of Gujarat FDCA tried his best to express some of his concerns about certain unacceptable suggestions. One has to realize that the term nutraceuticals denotes a class of nutritional products having therapeutic values. The term therefore should exclude just food supplements or nutritional products outside the purview of nutraceuticals. What is now lacking in the country is a clear definition of nutraceuticals in India. Nutraceuticals and functional foods represent one of the fastest growing markets in the developed world. The worldwide market for these products is estimated to be about 86 billion dollars with an annual growth rate of 17 percent. Considering the current trends towards healthcare cost reduction and the growing consumer interest in preventive health, it is expected that this industry will continue to exhibit strong growth rate in the coming years as well. In the market including in India, almost all nutraceuticals do make either a preventive or a curative claim for one or more health disorders. Most of these claims are either false or misleading. Therefore any legislation and machinery to regulate these products should be well defined with adequate consumer safety provisions. And to make future deliberations on this subject meaningful and complete, there should be adequate participation from consumer groups and medical experts.

 
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