FSSAI – Hurdles to Harmonisation!

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

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).