Probiotic foods, which are currently classified as general foods and are subject to little regulation, are soon likely to begin being governed by a set of stringent guidelines. The Indian Council of Medical Research (ICMR) and the Ministry of Science and Technology’s department of biotechnology have released their draft “Guidelines for Evaluation of Probiotics in Food in India”, proposing how probiotics should be governed by law. The ICMR has invited comments on the draft guidelines.
Probiotics are live, non-pathogenic micro-organisms that benefit the consumer’s digestive system by boosting the naturally existing gastrointestinal microflora. This prevents the colonization of the intestine by pathogens and so improves the immune system. Probiotics are available in the marketplace in the form of health foods and dietary supplements.
The Indian probiotic market is currently regulated by the laws that govern general food items. These laws include the Prevention of Food Adulteration (PFA) Act, 1952, and corresponding PFA rules of 1955; certain food product-specific orders under the Essential Commodities Act, 1955; and the Standards of Weights and Measures Act, 1976, and Standards of Weights and Measures Rules of 1977. The PFA rules specify minimum standards for the quality, content, labelling and packaging of food products.
Probiotic food products are sold as food, but the intention or claim that they have a therapeutic effect takes such products beyond the ambit of ordinary food articles as envisaged under existing legislation. In addition, it is a cause for concern that the probiotic cultures being used in currently available food products are of foreign origin, and hence untested on the gut microflora of the Indian population. The lack of appropriate legislation has prompted regulators to initiate the development of what is intended to become a thorough set of guidelines to govern the use of probiotics in food.
The conditions prescribed for probiotic foods and their manufacturers in the guidelines include:
- in vitro tests, including tests mimicking the hostile gut environment;
- in vivo tests in appropriate validated animal models;
- in vivo tests on humans in four phases, to determine safety and efficacy;
- certain labelling requirements in addition to those prescribed by existing food laws; and
- the requirement for Good Manufacturing Practices (GMP) and the Codex General Principles of Food Hygiene and Guidelines for Application of Hazard Analysis and Critical Control Point (HACCP) to be applied in the manufacture of probiotic food products.
The market is currently awaiting the final set of guidelines, which will lay down the precise clinical study requirements that would have to be conducted to substantiate the health claims of probiotic foods.
The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at [email protected] Readers should not act on the basis of this information without seeking professional legal advice.