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.
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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
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- 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
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- 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
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| 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
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- 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
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| 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
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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. |
