The class of products christened 'Nutraceuticals' had a relatively late entry into the Indian Healthcare scene, even though diverse preparations originating from Indian Systems of Medicine (ISM), notably Ayurveda have been marketed by several Companies, mostly as health rejuvenators, for decades. The approval for marketing these products are granted by State Governments' Regulatory Agencies under the advise of experts in ISM.
The general principle adopted is that the constituents of the preparation should have been mentioned as therapeutically useful in one or more of classical texts of ISM or in published Pharmacoepias. In such cases no additional clinical validation of their safety or efficacy is required to be provided. The products are marketed as ISM drugs under the OTC category. To encourage the revival and promotion of such products, the Government of India has provided incentives in the form of tax benefits, and relief from administered prices, in addition to much less stringent licensing or regulatory controls and standards.
The confusion not only among the regulatory agencies but also among the consumers including the medical profession as well as the patients arise out of the lack of clarity in defining the precise nature, function and utility of these products as well as ambiguities with regard to their safety and efficacy,
The Drugs & Cosmetics Act 1940
The essential features of the current Drug Regulatory System in the Country more or less follows the first Drugs Act passed in 1940 as a follow-up on Chopra Committee's recommendations for setting up Drug Control Agencies at the Centre as well as in all the States to make appropriate rules for the manufacture, distribution and sale of all drugs, in the interest of public health and welfare. However, it was only in 1964, that the Act was amended to include Ayurveda and Unani under its purview.
The original Act of 1940 and the Rules 1945 also had set up comprehensive Schedules covering among others, Schedule G (labeling), Schedule H (Prescription), Schedule M (GMP), Schedule P (Shelf Life), Schedule T (GMP Standards), Schedule V (Patent & Proprietary Medicines) and Schedule Y (New Drugs & Clinical Trials). The Magic Remedies Act prohibits claiming usefulness of Drugs for which there is no evidence that drug treatment of any kind would be beneficial.
What have been lacking in the Indian Drugs & Cosmetics Act 1940 are provisions for covering several other healthcare products used by human beings, including Nutraceuticals, widely marketed in the Country.
Mashelkar Committee Recommendations
The Expert Committee for " A Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs" set up by the Government deliberated among other subjects the issues related to the need for setting up Regulatory Standards for Dietary Supplements. This was deemed to be extremely important since these products are gaining increasing popularity not only in India, but also all around the World as a complementary system of healthcare. This is primarily due to the fact that many modern drugs are considered to have minimum preventive roles, being mostly curative in their approach and even there, are largely palliatives for symptom relief rather than offering real cure.
Increased recourse to Nutraceuticals are seen to improve health, prevent or delay disease onset and offer remedies either in the initial stages of the disease or in very late stages where modern medicines have no further remedies to offer. Even though definition of what is a Nutraceutical product is not clear, it has been estimated that the market size of this segment was around Rs 2,300 crore in 2001 and Rs 4,500 crore in the current year. In other words they would constitute around 20 - 25 % of the country's pharmaceutical sales.
On the fundamental question as to whether these products are to be considered as therapeutic agents (drugs) or are functional foods providing extra benefits of a nutritional nature, the answer in most countries rely on claims on the label made by the manufacturers. As of now, India has no legislation or even guidelines to regulate the manufacture and marketing of Nutraceuticals, unlike in the U.S.A which has the Dietary Supplements and Education Act (DSHEA), the European Union, which has the directive on Food Supplements and Japan with its Foods For Specific Health Use (FOSHU).
India, however has specific Food Laws, of which only the Prevention of Food Adulteration (PFA) comes under the purview of the Drugs & Cosmetics Act. Certain types of Nutraceuticals which fall under "Patent & Proprietary Medicines", which may or may not claim therapeutic properties and Cosmetics which have no therapeutic utility are included under the Drugs & Cosmetics Act. Even though there have been earlier recommendations by Committees constituted by the Director General of Health Services (DGHS) and the Department of ISM & H of the Ministry of Health in 2000 and 2002 respectively, no decisions have been taken so far on their implementation by the Government.
It is a moot point whether legislative amendments are required to enforce all or part of those recommendations or whether they could be implemented through administrative caveats either under statutory provisions or as guidelines.
The Mashelkar Committee considered all the previous recommendations for the planning and implementation of an equitable regulatory system for Nutraceuticals. Unlike in other areas, there are several aspects to regulating Dietary Supplements. They concern Raw Material Availability and Quality, Safety, Efficacy, Product Quality, Labeling and Marketing Ethics and Practices. Further, most Nutraceuticals have as their basic sources, materials from Plants, Animals, Microbes, Minerals, and Chemicals, all of which having their own unique problems of availability, accessibility and quality.
The processes of manufacture include extraction and fractionation, fermentation using product-specific microorganisms and chemical synthesis. Even the same Dietary Supplement manufactured by different manufacturers do not often meet the same standards and specifications Thus it is obvious that evolving a uniform standard for the Dietary Supplement of identical composition whether classified under the Food or Drug category is not easy.
Considering all these issues and taking into account the various earlier recommendations during the last five years by different agencies on the subject, it was considered prudent to recommend a regulatory system to streamline the activities of the Nutraceuticals Industry through appropriate legislations under the Drugs & Cosmetics Act or under the Food Act, prevailing in the Country. The following recommendations when implemented will ensure that the Industry will provide quality products manufactured under Good Manufacturing practices and supported by adequate and sound evidence for their safety and efficacy.
1) All Nutraceuticals in the market or to be marketed to be classified as either Dietary (Food) Supplements or as Drugs as defined under the Food Acts or the Drugs & Cosmetics Act.
2) Food Supplements, which do not have on their labels and /or are not promoted as having therapeutic properties should be regulated under Food Laws which need to be amended if necessary to include them.
3) Products which claim to have utility as prophylactics, diagnostics or therapeutic agents should be considered as Drugs and would come under the purview of the Rules & regulations under the Drugs & Cosmetics Act.
4) Whether they should be under Schedule H, Schedule K or under a new category of OTC drugs is to be determined by their safety profiles and track record of use.
5) In both cases, adequate evidence consistent with the claims made should be provided to establish their safety and efficacy in humans.
6) If retrospective data is not adequate, prospective studies should be carried out.
7) All products regardless of the categorization should meet minimum current Good
Manufacturing Standards (cGMPs).
8) The labels should have list of contents, their composition, warnings on safety and possible adverse reactions and shelf life where relevant.
Regulation on Products of ISM&H
The Department of ISM &H under the Ministry of Health, administers all the activities involved in the revival and promotion of drugs based on ISM &H in the Country. At present products, which originate from any of classical texts on ISM or in the Pharmacoepias do not have to establish their safety and efficacy profiles using traditional or modern methods. These stipulations do result in lack of uniformity in the quality of the products in the market leading to adverse effects on the consumers.
Considering that the ultimate objective is to use these products based on ancient Systems of Medicine for healthcare globally, it is imperative that a detailed study should be undertaken to ensure their rationality based on available knowledge, good manufacturing process, standardization and quality control before they are marketed for human consumption.
The scientific rationale for the development and marketing of ISM-based products need not necessarily be based on modern scientific methods; they could very well be based on established norms under the Indian Systems of Medicine. When the administered dosage forms are 'modernised' in the forms of tablets, capsules etc., they need to follow the processes dictated under the modern system and should use only permitted excipients. Since in the case of traditional processes, fermentation to produce alcohol happens in situ, resulting in having alcohol content in the final product, as in the case of Asavas and Arishtas, extraction of natural material using alcohol could be permitted to ensure that alcohol - soluble in addition to water-soluble contents would be present in the extract used. It is important that adequate human clinical data is generated for these products, which establishes beyond reasonable doubt their safety and therapeutic usefulness.
Considering the track record of use of these products in humans for several centuries, most regulatory agencies including the U.S. FDA do not insist on pre-clinical in-vitro and animal in-vivo data for product approvals. Here again they could be approved for marketing as prescription only or as OTC products, based on the same yardsticks applied for non-ISM drugs.
It is thus obvious that both Nutraceuticals, as well as products marketed under ISM labels, which together could constitute as much as one-third of the pharmaceutical market in the Country, should be brought under appropriate regulatory mechanisms and controls, so that they serve effectively not only as alternate systems, but as complementary to modern medicine, thereby filling the current gaps in therapeutics for many disease areas.
-- The author is a leading scientist and industry observer