Manufacturing and marketing of nutraceutical products in India is a fast growing segment attracting large number of multinational and Indian companies. Although these products are available in the Indian market for over a decade, there is no effective regulatory system or marketing regulation over them as yet. Various government agencies have been debating the need for a regulatory system for these products as they do not fall under any specific law of the land. Currently, nutraceuticals and food supplements are neither classified as food nor as drug for the licensing purposes in India. Therefore, there is no appropriate regulatory framework exists for nutraceuticals. This lack of clarity in regulation has been responsible for the growing number of products in this category with false and unsubstantiated medical claims. Although the drug authorities can act to curb marketing of these products with medical claims under the D & C Act, there has been hardly any such interventions in the past. The industry bodies instead of pressing for a legal status for these products felt it convenient that nutraceuticals are out of the purview of the D & C Act and hence could be manufactured and sold without a drug license. Similarly, the Prevention of Food Adulteration Act in its present form is inadequate to regulate the quality of nutraceuticals. This situation has given a free hand to MNCs, ayurvedic, herbal and some of the leading pharmaceutical companies to promote and market nutraceuticals with excessive claims throughout the country. It appears that the attempts to sell products as nutraceuticals are manly to take advantages in pricing, promote through advertisements and avoid quality issues by drug regulatory bodies.
With whatever unsubstantiated claims, nutraceutical products have come to stay in the Indian market and they may remain in the years to come. Products like Glucosamine HCI with Boswella, claimed as a drug for joint pain, Siberian Ginseng, an aphrodisiac with a claim to improve 'work endurance and stamina', Triple Guard Echinacea and NutraliteKid are already there in the market. Indian companies like Ranbaxy, Alkem, Troica Pharmaceuticals and Parry Nutraceuticals have been also marketing these products for some years now. The option for the regulatory authorities, therefore, is to classify and regulate them effectively in the interests of the consumer at large. Before that the Indian Pharmacopoeia Commission need to examine the status of nutraceuticals, classify them and prepare standards for them. This can be done as per the provisions of the D & C Act and appropriate regulatory provisions can be incorporated. The nutraceutical industry on its part should also take a pragmatic stand in matters of pricing and advertising, as quite a few of them indulge in profiteering and unethical practices when they sell these products. The 5th Nutraceutical Summit starting from October 28 to 30 in New Delhi is probably the right forum to deliberate these issues involved in manufacturing and marketing of these products as most stakeholders of this sector will be present in the same venue.