Update on India (June 2006)

The Indian Food Safety and Standards Bill 2005 was introduced in the Indian Parliament by the Ministry of Food Processing Industry on August 25, 2005, vide Bill no 123. (http://mofpi.nic.in/foodsfty.pdf) This bill maps and identifies the current deficiencies in monitoring that currently exist and provides suitable, relevant and meaningful regulations for different FOOD and FOOD related products. Trade Association INHADSA/HADSA, in association with CSIR and CFTRI has been at the helm of bringing regulators (Ministry of Health/State FDA’s/Ministry of Food Processing Industry ) and industry together since 2002 for recognizing the emerging 3rd dimension healthcare category in India classified as Dietary Supplements / Nutraceuticals /Functional Foods or Foods for special dietary application.

Numerous recommendations were proposed to an earlier Government in December 2004, for regulating dietary supplements, and these recommendations would have been separately categorized under the existing Prevention of Food Adulteration Act. However early general elections prevented clearing of this bill and the government was defeated. As a result the new government formed a high level committee comprising 6 Union Ministries including the Ministry of Agriculture, Ministry of Health, Ministry of Food Processing Industries, etc., headed by Mr Sharad Pawar- Union Minister for Agriculture. The purpose of this group was the urgent need to understand the rapidly changing regulations for foods all around the world, as well as new food products introduced by Indian Industry and the need to identify and provide better regulations to safeguard the interest of consumers and industry at large, channelize revenue stream for Industry and Government, generate better employment opportunities, and of course, better quality products conforming to the new regulations. This committee interacted rapidly with all stakeholders and proposed The Indian Food Safety and Standards Bill 2005.

This Bill was introduced by the Ministry of Food Processing Industry in Parliament in August 2005, but was not debated due to lack of adequate time. The bill was scheduled for the next parliamentary session in May 2006, however on May 25th, when the bill was again presented by the Ministry of Foods Processing Industry, there was no quorum of members of parliament. Despite insistence from the Ministry of Food Processing Industry on the importance, the speaker of the house ruled that this bill be taken up during the Monsoon parliament session scheduled for July 2006. (After the Lower house passes this bill, it will go to the Upper house, then to the President, and finally a Food Regulatory Authority of India will be constituted which will look into setting the rules and regulations under the new Act.)

INHADAS/HADSA/CSIR/CFTRI and other industry associations have been providing much input into these regulations. These recommendations were incorporated under Chapter IV, item 22, Pg 20 of The Indian Food Safety and Standards Bill 2005. This Chapter identifies products which can be manufactured, distributed, or imported such as any novel food, genetically modified , articles of food, irradiated food, organic foods, foods for special dietary uses, functional , foods, nutraceuticals, health supplements, proprietary foods and such other articles of food approved by the Central Government.

Definitions:

1) "Foods for special dietary uses or functional foods or nutraceuticals or health supplements" means:

(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist and may contain one or more of the following ingredients, namely:-

(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or combination;

(ii) minerals or vitamins or proteins or metals or their compounds or amino acids ( in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);

(iii] substances from animal origin;

(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake;

(b)

(i) a product that is labeled as a 'Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods' which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;

(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) snd (h) of section 3 of the Drug and Cosmetic Act, 1940 and rules made there under; 35 23 of 1940.

(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the rules made under this Act;

(iv) does not include a narcotic drug or a psychotropic substance as defined in the schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 and rules made there under and substances listed in Schedules E and 61 of 198s. of the Drugs and Cosmetic Rules, 1945;

(2) "Genetically engineered or modified food" means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing genetically modified or engineered organisms obtained through modem biotechnology;

(3) "Organic food" means food products that have been produced in accordance with specified organic production standards ;

(4) "Proprietary and novel food" means an article of food for which standards have not been specified but is not unsafe:

”Provided that such food does not contain any of the foods and ingredients prohibited under this Act and regulations made thereunder.”

The proposed regulations cover manufacture, distribution, sale or exposure for sale, including food business operators, including the advertising, marking and labeling, and prohibition of any statement, claim, design or device which is false or misleading in any particular concerning the food products, contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims or in relation to the place of origin. Specifically the proposed regulations state that "No person shall engage himself in any unfair trade practice for the purpose of promoting the sale, supply, use and consumption of articles of food adopt any unfair or deceptive practice including the practice of making any statement, whether orally or in writing or by visible representation which-

(a) falsely represents that the foods are of a particular standard, quality, quantity or grade-composition;

(b) makes a false or misleading representation concerning the need for, or the usefulness;

(c) gives to the public any guarantee of the efficacy that is not based on an adequate or scientific justification thereof: Provided that where a defense is raised to the effect that such guarantee is based on adequate or scientific justification, the burden of proof of such defense shall lie on the person raising such defense."

As this Bill moves towards passage, its impact is still a bit unclear. From INHADSA/HADSA we have this vision on how the bill will change the environment including the current status of product availability and the chance to make claims.

From INHADSA/HADSA :

“When this bill is passed, the Ministry of Health will most likely be involved in governing the new regulation, but chances are that the Ministry of Food Processing Industry will also likely stake a claim to regulate it. The Ministry of Health will issue official notification to all it's state FDA regarding the new rule so that currently all those manufacturers who are manufacturing these products under food licenses under the prevention of Food Adulteration Act , will be able to apply for fresh licenses under the new rule. The companies will not be under the threat of revoking their current license.

The new rule will define what health/nutritional claims can be made and which cannot be made. Manufacturers will be encouraged to do product R&D, new product development , develop reliable testing protocols, carry out various kinds of clinical studies and establish structure function claims based on these studies.

These products will be out of price control, so price will be regulated by market forces, meaning better revenue generation for industry, better quality products to consumers, revenue generating to central and state government through taxation , new employment opportunities in R&D, Production, clinical studies, food safety studies, new avenues for GMP/HACCP/Organic certification, ,overall good quality competition, better marketing and better informed choice for consumers to select products. It is possible too that many Pharmaceutical companies can divert their latent potential in R&D and manufacturing for safety studies/clinical studies. It is conceivable too, since many Pharmaceutical companies have a widely spread out network for the ethical marketing of pharmaceutical products, that this network will be utilized for the marketing of dietary supplements. Questions will surely arise over the enthusiastic marketing and cross-over of the line between medical claims and health claims, but the regulatory guideline will check this risk.

Foreign companies can easily export dietary supplements products into India .There will be newer opportunities for marketing tie-ups between such foreign companies and their Indian counterparts. So a new economic growth opportunity is seen. Consumers will get a better choice of products, with more reliable science.”

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