FSSAI – Hurdles to Harmonisation!

FSSAI – Hurdles to Harmonisation!

Narayan Kulkarni

To a large extent Food Safety and Standards Authority of India (FSSAI) has created a level playing field among stakeholders of the industry, which is waiting to see the authority to build strength, regulate the market and streamline and accelerate the process of product approvals to that the local nutraceuticals industry can become a leading player in the global market.

The Indian Parliament passed Food Safety and Standard Act in 2006 (FSSA), to integrate and streamline the many regulations covering nutraceuticals, functional foods and dietary supplements, as the industry has been facing issues such as multiple food laws, varied standards that are restricting innovation, limited manpower, poor labs and infrastructure, rigid standards, non-responsive to scientific advancements and modernisation and poor level of consumer interface. Food Safety and Standard Act of 2006 will ensure improved quality of food for the consumers and censure misleading claims and advertisement by those in food business.

The Food Safety and Standards Act 2006, which came into effect from August 5, 2011, five years after it was passed in
Parliament, subsumes eight different Central Acts. It will ensure prevention of fraudulent, deceptive or unfair trade practices, which may mislead or harm the consumer, and unsafe, contaminated or sub-standard food.

An authority – The Food Safety and Standards Authority of India (FSSAI) – was established in 2008 under the overarching legislation to implement the Act, which will lay down science-based standards for food items and regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

Immediately after announcing the opening of FSSAI, the first Chief Executive Officer, V N Gaur, said, “the Food Safety and Standards Authority will broadly frame regulations to lay down the standards and guidelines for food items and specify an appropriate system of enforcing various standards. It will specify mechanisms for accreditation of certified bodies engaged in certification of food safety management system for food businesses, and procedures for accreditation of laboratories.”

As rightly pointed out by Sanjay Dave, Chairperson, Codex Alimentarius Commission, The Food Safety and Standards Authority of India was established as a single reference point for all stake holders of the industry to help achieve high degree of consumer
confidence; to work as an effective and transparent regulatory framework; to provide adequate information to consumers for informed choice; to help in decentralisation of licensing; to provide integrated response to novel/ genetically modified foods, trade, etc. and also to help in speedy disposal of cases.

In the last two years of existence, the FSSAI has constituted apex scientific committees to provide scientific opinion to the authority on wide range of subjects that are within the mandate of the authority. The Scientific Panels on Functional Foods, Food Additives, Method of Sampling and Analysis, Biological Hazards, Contaminants in Food, Pesticides and Antibiotic Residues, Genetically Modified Organisms and Food and Labelling, claims/advertisements have been formed. It has also begun the exercise of harmonising the standards for the various food items.

As required under the Act, 22 States and Union Territories have Food Commissioners in place, while seven are to follow. All the states have operationalised the FSS (Licensing and Registration of Food businesses) Regulations, 2011. About 2,77,801 licences and 8,60,119 registrations have been issued by the state governments as of March 2013. At the Central level, 9,348 licences have been issued till March 11, 2013.


Making a new beginning
The FSSAI has taken many initiatives for fixing standards of food articles. These initiatives from the government received mixed responses from different stakeholders of the industry.

Hailing the new initiatives, V S Reddy, Chairman and Managing Director, British Biologicals, said, “Indian consumers have never been known to question a product’s efficacy in the past. Given this scenario, it is really heartening to note that at last there is a regulatory system in place at the Government of India level to protect their interest. The consumer will now be ensured of quality and science based products and dubious products will be weeded out. Substandard products will leave the market and it will leave a positive impact on the industry.”

“The new system is a blessing for all stake holders. And it definitely helps the industry,” said Reddy and added, “First and foremost, it brings accountability into the system, both at industry level as well as at the consumer level. Secondly, it helps in bringing quality products at competitive prices to the end consumer. The regulatory body will also be a huge support in terms of spreading awareness on the benefits of disease specific nutritional products. By and large, it helps in the growth of the industry and the need of the hour has been met with this controlling authority.”

Chairman and Managing Director of Avesthagen, Dr Villoo Morawala-Patell, said, “We have a good policy. The new Act will help the industry but it needs to be implemented and followed. We will deliver good and well priced quality products to the public.”

Different Acts brought under FSSA 2006
Vegetable Oil Products (Control) Order of 1947 Prevention of Food Adulteration Act of 1954 Fruit Products Order of 1955 Any order issued under the Essential Commodities Act, 1955 Essential Commodities Act, 1955 relating to food	Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order of 1967 Meat Food Products Order of 1973 Edible Oils Packaging (Regulation) Order of 1988 Milk and Milk Products Order of 1992

Initiatives of FSSAI for fixing of standards of food articles

1. Draft standards for caffeinated beverages have been formulated and are under notification for seeking public comments. 2. Draft notification for fixation of limit of trans fatty acid in partially hydrogenated vegetable oil, has been notified for seeking public comments. 3. Draft notification for fixing standards for antibiotics in Honey, has been notified for seeking public comments. 4. Draft standards for olive oil have been notified for seeking public comments. 5. Regulations of alcoholic drink – alcoholic drink has been defined as food under Food Safety and Standards Act 2006 and the process of framing standards and regulation thereof has begun. After following the prescribed process of standards setting, the same would be brought to the food authority for discussion. 6. Draft regulations of imported food safety have been framed.

Sharing his views, Dr Dilip Ghosh, Director at Nutriconnect, Sydney, Australia, says, “It was a very bold and much-needed framework for both Indian industries as well as global companies, who are in the process of entering Indian market. But due to legacy of bureaucratic system, it is still uncertain about the final outcome of this regulatory framework. I am looking with great interest how SMEs are responding to these changes. Still effective patent protection of innovative clinically proven natural medicines/ nutraceuticals is a big problem in India.”

The most important trend in the food safety standards is that it takes a holistic view of the problem and comes out with solutions, which are acceptable to the industry. “The FSSAI standards are very helpful to the industry as it gives insight to the fine points, which normally are overlooked by the industry and create problems. The regulatory system needs more effective implementation by government, who must train their staff on regular basis as there is a dynamic process of novel products coming into the market and consumers are not fully aware of the benefits. The government has to intervene to protect the consumer from fly-by-night operators,” said Kumar Bhatia, Adviser, Ministry of Food Processing Industries and former Managing Director, National Seeds Corporation.

“Implementation of FSSAI Act is welcome for our growth and top up with our quality and access in international clients and markets. This new regulation perhaps may be the ideal one where it provides a wide spectrum of regulatory clarity making approval process stronger. Thus providing confidence among global consumers where there is a clear distinction on use of ingredients –between drug and food use – unlike other softer approval process in some of the leading countries,” points out Dr Baidyanath Mishra, Vice-President, Product Development, Regulatory and Medical Affairs, Katra Phytochem.

Need to address more concerns 

By defining the nutraceuticals, functional foods and novel foods categories FSSA has given the much needed structure required to develop this emerging segment. Reacting to the changes in regulatory set up, Frost & Sullivan said, "The food industry sees the FSSA as a mixed blessing. This would enable the companies in this segment to clearly differentiate themselves from 'poser' products. As a result, not only the companies benefit but the consumer is also able to make an informed choice. However, the authority is yet to clarify on overlaps among the definitions leading to potential confusion. Until this area is clearer, the companies may find it difficult to adapt the new practices ultimately increasing the time to market new products."

While, features such as single window for licences and special courts to settle disputes have been welcomed, Frost & Sullivan further said, "The industry is still worried about the FSSA due to various concerns. For example, the food safety administration is understaffed and 250 (approximate) food sample testing labs that currently exist in India are insufficient. Only increase in number of testing labs and staff will help to enforce the upcoming regulation. While the government is planning to launch another 125 (approximate) food testing centres over the next few years, this represents an opportunity for private players to enter this space. Also, while companies expect the lead time to settle litigations and implement their expansion plans to decrease drastically when the FSSA policies are implemented, the related costs are unclear. Furthermore, the cost of implementation of new regulations is most likely to be passed onto the consumer, resulting in increased food prices."

Making his point, Prof Huub L M Lelieveld, President, Global Harmonization Initiative (GHI), GHI Association, The Netherlands, said, "India is a very large country and correct regulations alone will not achieve the goals of the law. In most countries inspection is insufficient to prevent malpractices. Therefore, there must be ample attention to inspection, meaning that knowledgeable inspectors are needed and these must be educated and trained. This needs to be stimulated so that there will not just be enough inspectors in the future, but also that they will have the required capabilities. This applies equally to all food products, including neutraceuticals."

Says Dr Ghosh of Nutriconnect, "I see a bright future for the Indian industry, which is involved with food, nutritional, nutraceutical and natural medicine’s research and development, commercialisation and marketing areas. There are few grey areas such as food-medicine interface need to be analysed and regulated properly. The regulatory scheme of non-prescription drugs is not very clear."

The concept of "nutraceuticals" is still developing in India and there are no regulations dealing specifically with nutraceuticals or functional foods. K V Venugopalan, President, Indian Analytical Industry Association, said, "It is also essential to have specific regulations as regards to product approval, approval of claims, permitted additives, quantity of vitamins and minerals etc. for nutraceuticals as it is necessary to treat this segment as independent and unique entity under the Food Safety Standard Act 2006. Once these regulations are in place and implemented properly, it will benefit the consumers to a great extend as well as the Instrument suppliers as the market opens up for large scale investments."

Achievements So Far
Food Commissioners in place 22 States and Union Territories FSS (Licensing and Registration of Food businesses) Regulations, 2011 operationalised in all states Over 2.77 lakh licences and 8.6 lakh registrations issued by the state governments till March 2013 Over 9,000 licences issued at the Central level, till March 11, 2013

Areas of Concern

No clarity yet on overlaps among the definitions leading to potential confusion with companies may finding it difficult to adapt the new practices leading to delay in marketing new products Understaffed administration; Insufficient food sample testing labs Need for ample attention to inspection, requiring knowledgeable inspectors, who are educated and trained Food-medicine interface need to be analysed and regulated properly Lack of clarity about when a product is main line food and when supplement Inadequate fund allocation

Reacting sharply to the developments about the new regulations on nutraceuticals industry, Dr R K Sanghavi, Chairman - Nutraceutical Subcommittee, Indian Drug Manufacturers’ Association (IDMA), said, “Nutraceutical industry will be suffocated to death and Food Business Operators (FBOs) will churn out useless products (homeopathic quantities) for business continuation resulting in depriving patients of real benefits of alternative natural products.”

Airing similar sentiments, Krishna Kumar Joshi, head, Regulatory Affairs, Foods Division, ITC Ltd, said, "The draft regulation made is not comprehensive and lacks many aspects such as lack of clarity when a product is main line food and when supplement; lack of comprehensive regulation like Dietary Supplement Health And Education Act of 1994 (DSHEA), a 1994 statute of United States Federal legislation, which defines and regulates dietary supplements, which to a great extent gives clarity on supplements; Lack of regulation on dietary ingredient; Lack of the date, which is used to define new dietary ingredient; Labelling requirement for supplements including any disclaimers; Some given claims, which can be made based on the ingredient e.g. calcium osteoporosis, Psyllium husk - cholestoerl management as US DSHEA/ Food and Drug Administration (FDA) allows. However, there is a guideline or regulation for food for special dietary uses (FSDU)/ Nutraceuticals/Functional food is under review stage at FSSAI scientific panel."

Looking pragmatically at the opportunities and challenges, Sandeep Gupta, Vice-Chairman, Nutraceutical Sub-Committee, Indian Drug Manufacturers' Association, pointed out that the industry bodies and government to form a platform to have common consensus in order to prevent and repair damages rather evolves ideas to build the strength of this sector.

Gupta further said, "We need to take up positive initiatives and quick actions to foster nation’s objective to arrest further malnutrition, under nutrition and meeting adequate/ appropriate nutrition through awareness of nutrition through various routes and facilitate good health together for better tomorrow and rise up on to the global map. Food industry is one such platform and medium, which would help attain such status. Earlier the better we come together before these ambiguous regulations/ governance turns up to just debate and then finally into legal battle which will affect our people’s health. We need to create positive actions to move forward."

Echoing similar thoughts, Dr Ghosh of Nutriconnect said, "FSSAI needs to take steps for introduction of industry self-regulation and joint regulation with industry bodies besides providing better intellectual property protection and introduction of commercial incentive to innovative companies, who are investing money for product development and human trial."

"The new system can benefit the nutraceutical industry if the government brings in separate rules for proprietary foods, nutraceuticals, etc.; appoint panellists, who have worked in nutraceutical industry for 5-10 years and handled products (sales & marketing - not mere R&D, research) and medical doctors, especially with nutra background, who should be a guiding force rather than government officials associated with research, analysis etc of foods," Dr Sanghavi added.

Dr Baidyanath Mishra said, "FSSAI would work towards providing cut-edging technology in processing, provide a clear cut traceability mechanism, proper implementation of food safety management system in every premises, consumer friendly promotions with proved claims, encourage the clinical trial proven health beneficial or disease reduction claims, and most crucial is to provide best of the best products within reach of common people."

Sharing her comments Neeraja Shetty, Director and President, Strategy and Business Development, Sami Labs, said, "The new reforms and regulations will bring in a sense of clarity in the regulatory guidelines, the lack of which had given rise to various spurious products in the market, poor in quality, unscientific in claims and no safety data. The 12th plan was initially scheduled to sanction Rs 5,000 crore to strengthen FSSAI. However, the authority received Rs 2,350 crore, which will definitely create a deficit and hamper and delay FSSAI’s plans of improving infrastructure, staffing and setting up new testing labs."

Despite shortfall in the budget, to a large extent FSSAI has created a level playing field among stakeholders of the industry, which is waiting to see the authority to build strength, regulate the market and streamline and accelerate the process of product approvals to that the local nutraceuticals industry can become a leading player in the global market.

The government should offer incentives to the industry like tax and excise holidays. This will encourage more and more Indian companies to set up nutraceutical industries. “Government can also help domestic entrepreneurs through identifying and setting up channels for exports. Infrastructure for research, forming industrial layouts for nutraceutical units etc., can go a long way in further catapulting the growth of this sector in India, “added V S Reddy of British Biologicals.

"I see a very significant attention to nutrition and the involvement of many nutritionists in the process of developing the regulations and standards. The Indian government clearly do not only address safety (which is the focus of e.g. the EU, USA, Japan, Korea, etc.) but also pay, rightfully, much attention to nutrition. The health of the consumers and particularly children is at least equally influenced by sufficient intake of essential nutrients as by contamination of food by harmful substances and microbes," concludes Prof Huub L M Lelieveld, President of Global Harmonization Initiative (GHI).

Regulatory Challenges

1. Lack of establish rules & regulations for nutraceutical products, current governance have no clarity of operating segment in Healthcare sector under Section 22 (Proprietary Food). 2. Ingredient standardisation will help create good standards and safety control rather asking for Product Approval which is making chaos and delaying execution of rules and regulations affecting the whole food industry. 3. Exorbitant application fees for approval, no rationalisation which is unpractical affair this percolates down and impact the operational economy especially for Micro and Small companies. 4. Referral of product for Scientific Committee assessment (with additional equal fees paid extra) for simple nutraceutical ingredients which are already in market overseas, even in India since years and having ample documentation on net. This system not forming specific rules under section 22 by itself will defeat the purpose for process. FBOs, inclusive of all streams, need final rules to comply will lead to challenges for both the government and industry. 5. Site approval ‘dependant’ on Product Approval. 6. Exorbitant repeated cost incurred by the FBOs travelling to Central Office for application filings. Lack of State/Zonal interface for PA applications. 7. Variable advisories without established rules causing phenomenal confusions and uncertainties - resulting filing or re-filing of the dossier already with duplication of fees. 8. New Business Opportunities/New Entrants/Innovation has become standstill impacting the complete sector under such ambiguous law with no clarity. Segregation of Proprietary Food rules is a must or else would be death of 9. Nutraceuticals sector in India as such we are invisible on the global graph. 9. Product rejection done without scientific reasoning when Section 22 has not been framed. 10 Lack of healthy dialogue with industry bodies to form co-operation by government and industry by understanding practical experiences, difficulties, limitations impacting ultimate to consumers with such uncertainties causing confusion and also considering the situation when future disease risk is very high if not supported with good and right supplements at the right time 11 RDA for nutrients imposed rather than upper tolerable limits which is the global norms to have better control of safety parameters and offer appropriate benefits of supplements in specific conditions/needs of individuals for good health. Early conclusions without evaluation and healthy dialogue will be the loss of good health for Indian Population.