The exporters of nutraceuticals to the US have appealed to the government to consider vitamin supplements and nutraceuticals as food supplements and not drugs. The companies' representation comes in the wake of the government's decision to keep these products under the purview of the Drugs and Cosmetics Act.

The exporters complain that ever since they started supplying nutraceuticals such as vitamin supplements and amino acids under the drug label, their export prospects started to decline. According to them, these products had always been exported to the US as food supplements and not as "drugs." The importers of these products are dealers in "food supplements" and not drugs. Since India started categorizing them as "drugs", the importers are facing US FDA heat for not complying with the strict norms meant for importers of drugs into that country. "We are facing the threat of losing our customers as they would prefer sourcing the same products as "food supplements" from other destinations rather than comply with the US FDA's stringent licensing system for imported drugs for getting this from India," they complain.

Interestingly, most of these companies have been engaged in exports for over 10 years now. While the export of food supplements to the US was carried out without much regulatory hurdle all these years, the industry is suddenly finding drug regulatory authorities clearing the products under drug laws. All the products that bear drug license need to go through strict quality control norms in US. It is also true that the importers who are not registered with the US FDA may have to renew their business model, once they start importing drugs instead of food supplements.

The Indian companies have informed the centre that if they are asked to dispatch the products as drugs, they will lose all their existing customers. They wanted their products to continue as food supplements.

Pharmabiz had reported that the health ministry has already decided to drop the plans for a separate Health Supplement Bill and has asked the ministry of Food Processing Industries to include the salient portions of the Health Supplement Bill in the Food Safety Standards Bill 2005 being finalised by the FPI ministry.

The news of "health supplements" moving towards the definition of "specialty food" and distancing itself from the definition of "medicine" should be encouraging to the nutraceutical industry who are worried about their export prospects. The nutraceutical industry has been lobbying hard with the health ministry to get "nutraceuticals" out of drug control department's purview.

The current appeal from the nutraceutical industry is for an interim measure to help their immediate export plans.