The status of Nutraceutical in Indian Drugs Regulatory system has been a point of debate for nearly a decade now. A sub-committee of the DCC headed by the then Joint Drugs Controller Mr.Aswini Kumar constituted to look into the issue of OTC drugs made an assessment of Nutraceuticals also in its meeting at Chandigarh when the industry was permitted to make presentations. Nothing really materialized either in the case of OTC drugs or Nutraceuticals, a newcomer in the field. The situation has not altered in the past nine years and the debate is still on. In the meantime several products starting from Glucosamine and Chondroitin combinations and strengthened by popular multivitamin-mineral combinations found way to the market in the name of Nutraceuticals or dietary supplements. Some were challenged in the courts of law while majority enjoyed free trade conditions. But the messages of these small developments were clear. The industry and regulatory bodies were well aware of the situation that the prevailing law did not provide for Nutraceutical. Strangely, the industry instead of pressing for a legal status found it convenient to take a stand that Nutraceuticals were out of the purview of the Drugs and Cosmetics Act and hence could be manufactured and sold without drugs license. It was and is a well known fact that the PFA Act in its present structure was inadequate to regulate the quality of Nutraceuticals. So what is the regulatory status of Nutraceutical?

The definition of drug in the Drugs and Cosmetics Act is wide enough to cover any substance manufactured for sale under any of the purposes stated there in and the sales promotion methods and claims for most of the products leave no option but to deem them as drug. So also are the combinations. A vitamin combination in therapeutic/ prophylactic dosage forms cannot be deemed as food supplement. A layman's understanding of a drug and food is very clear. A food or food supplement is one, which you take as you please as in the case of Horlicks or Complan while most of the other so called food supplement claimed multivitamin - mineral combinations are not and a drug is one advocated by physicians for specific purposes.

If it is agreed that there is need for regulation of Nutraceuticals, then the question and challenge are how? Surely the so-called Nutraceuticals do not enjoy any exemption from the Drugs and Cosmetics Act and as such they are drugs and are well regulated. If they are to be taken out of the purview of the Drugs and Cosmetics Act, amendment to the law is needed. Strangely it was the old ASU (Ayurveda, Siddha and Unani) department of the Government of India that took up the matter of regulating Nutraceuticals a few years back, but this move failed as it was bound to.

The options available in the matter are very limited. It is time that the question of regulation of drugs and foods is taken up together. In India, food and drugs are regulated by different bodies in most States while they are regulated by one combined administration in a few States. It is time that all States follow a uniform system and the preferable option would be to have joint administration that would enable minimizing duplication of infrastructure facilities and make optimum use of the available man power and equipments. The Indian Pharmacopoeia Commission should examine the status of Nutraceuticals and classify them and also prepare standards for them. These can be classified accordingly in the Drugs and Cosmetics Act and appropriate regulatory provisions can be incorporated. Considering the stand taken by the trade in the recent issue of house hold remedies, any effort to classify popular drug formulations, especially vitamin and mineral combinations, as food supplements and permitting free sale would be opposed by the trade bodies unless the law specifies supply through chemists only, and it would not be a wise move also to permit unregulated sale taking into consideration the situations prevailing in different parts of the country in the matter of fake and substandard drugs. Most manufacturers also prefer to promote sale of Nutraceuticals in the same manner as they do for drugs, especially detailing of doctors and supplies through identified stockists and chemists. It appears that the attempts to sell products as Nutraceuticals are only to take advantages in pricing, promote through advertisements and avoid quality issues by drugs regulatory bodies. As food supplements, the infrastructure in most states are poor to test such combinations and the products could be sold without any hassle. This, however, would not be in the interests of the consumer as also advertisements making tall claims.

Once classification by the IPC and inclusion in the IP are possible, it may be prudent to amend the Drugs and Cosmetics Act to provide for concessions without harming he interests of the consumers.

Nutraceuticals have come to stay and may well stay in the market. It may not be possible to do away with them. It may not be prudent also to do so especially when the global scenario is taken into consideration and India shall have to permit Nutraceuticals. The only option therefore is to classify and regulate them effectively under the Drugs and Cosmetic Rules and any further delay in doing so will harm the interests of the consumer at large.

The industry on its part should take a pragmatic stand in the matter of pricing and advertising, if these are the base issues. The common man has to shell out a lot of money on health care matters already and a well-developed Nutraceutical market should not become a burden to the common man. The regulatory provisions should take into consideration the situations prevailing in the direct marketing system also in the matter of dietary supplements. The recent issue of 'The Week' presents a fairly good picture of the immense fortunes earned by network marketing people but one has to remember that this is by exploiting the poor awareness of the large sector of health conscious common public believing that they have obtained some wonder remedies and other formulations. After all the Drugs and Cosmetics Act and the PFA Act are social legislations aimed to protect the interests of the consumer and so are the Essential Commodities Act and the DPCO. If self-regulation is possible, there would not be need for stringent legal provisions. But considering the prevailing situations in India it may not be a prudent move to do away with these regulations
- The author is Retd.Drugs Controller, Kerala State andFormer Member of the DCC, DTAB and WHO Consultant to GOI, Ministry of Health.