Nutraceuticals in India

Regulatory perspective of nutraceuticals in India

This article is shared from pharmaonline. Any one interested in making their own or selling nutraceuticals will have an idea of the licensing and regulatory requirements.

"Neutraceuticals"

Excerpts from a white paper published by Interlink, a business performance consultancy, which gives an overview of the Indian nutraceuticals market, latest happenings on its regulatory front and the requirements to be met by new entrants before entering it

Globally, the nutraceutical market was estimated to be $140.1 billion in 2010. Of this, US and Europe formed the largest markets accounting to 36 per cent and 25 per cent respectively.

In 2010, the Indian nutraceutical industry was estimated at $2 billion, roughly 1.5 per cent of the global nutraceutical industry. Broad segments of Indian nutraceutical industry include dietary supplement (40 per cent) and functional food and beverage market (60 per cent). The total Indian nutraceuticals market is expected to be approximately $5 billion in 2015.

Regulatory guidelines

Since nutraceuticals are not a part of pharma and drugs formulation, rules and regulations also tend to be different for this segment. Indian government has recently implemented the new law FSSAI (Food Safety and Standards Authority of India). As a result, there is some confusion in the minds of new entrants about the do’s and dont’s of the Indian regulatory system.

Transition perspective – the ideal scenario

"global nutraceutical market"
Exibit 1: Global Nutraceutical Market

The Food Safety and Standards Act, 2006 consolidates eight laws governing the food sector and establishes the Food Safety and Standards Authority of India (FSSAI) and its other allied committees to regulate the sector. The FSSAI comprises a chairperson and 22 members. The chairperson is either an eminent food scientist or a civil servant not below the rank of secretary. Seven of the members would be ex-officio, not below the post of joint secretary, from various ministries. Five members would be appointed by rotation every three years from the States and Union Territories. The authority would have two representatives each from the food industry and consumer organisations, three food technologists and two members from a farmers’ organisation and one from retail organisation. FSSAI will be aided by several scientific panels and a Central Advisory Committee to lay down standards for food safety. These standards will include specifications for ingredients, contaminants, pesticide, biological hazards, labels and others.

Everyone in the food sector is required to get a license or a registration that would be issued by the local authorities. Temporary stall holders are exempted from the license but need to get their businesses registered with the local municipality or panchayat.

The law will be enforced through state commissioners of food safety and local level officials. The Act empowers the FSSAI and state food safety authorities to monitor and regulate the food business operators. The commissioner of food safety of each state appoints a designated officer (DO), not below the level of sub-divisional officer, for a specific district. His duties include issuing or cancelling licenses, prohibiting sale of food articles that violate specified standards, receiving report and samples of food articles from food safety officers and getting them analysed. The state commissioner, on the recommendation of the designated officer, decides whether a case of violation would be referred to a court of ordinary jurisdiction or to a Special Court. The Act provides for a graded penalty structure where the punishment depends on the severity of the violation. Offences such as manufacturing, selling, storing or importing sub-standard or misbranded food could incur a fine. Offences such as manufacturing, distributing, selling or importing unsafe food, which result in injury, could incur a prison sentence. The sentence could extend to life imprisonment in case the violation causes death. Petty manufacturers who make their own food, hawkers, and vendors or temporary stall holders could be fined up to Rs 25000 if they violate the specified standards.

Current scenario

The Food Safety and Standard Rules, 2011 have been issued, effective from 5th May, 2011. The Food Safety and Standard Authority has also issued regulations about licensing and registration of food business, packing and labelling, food products standard and additive etc. These acts, rules and regulations have been implemented from 5th August, 2011. Thus, now there is one single legislation and specified authorities to regulate manufacture, sale and distribution of nutraceuticals, functional food and dietary supplement in India. However, due to lack of clarity of specific regulations for registration of nutraceuticals and permitted additives, entrepreneurs intending to launch nutraceuticals in India is still facing the following challenges.

i. Drugs defined under Section 3(b)(i) of the Drugs and Cosmetics Act, 1940 and also ayurvedic, siddha and unani drugs are specifically excluded from the scope of the definition of nutraceutical, health supplement etc. under Section 22 of the Act. The definition of drug under Drugs Act is very exhaustive. Taking recourse to the definition of drug, regulatory officers are categorising nutraceuticals, especially manufactured and marketed in tablet, capsule or liquid oral dosages form containing vitamin and minerals as drugs on the basis of even structure function claims.

ii. The regulatory officers also take a view that as empty gelatin capsule itself is covered by the definition of drug, any product marketed in capsule form will also be considered as drug.

iii. Some commonly used colours and additives such as binding agents, granulating agents used in formulating tablets do not find place in the list of permitted food additives under the regulations.

iv. Though the structure function claims are permitted, there is no clarity as to the permitted structure function claims for nutraceuticals and dietary supplements.

To overcome these difficulties, it would be necessary to amend Schedule K of the Drugs and Cosmetics Rules, 1945 to provide for specific exemption to nutraceuticals, dietary supplements, health supplements from the scope of Drugs and Cosmetics Act, 1940 and Rules, 1945.

It is also necessary to have specific regulations for product approval, approval of claims, permitted additives, quantity of vitamins and minerals etc. for nutraceuticals as it is necessary to treat this segment as an independent and unique entity under the Food Safety Standard Act, 2006.

Regulatory requirements for India entry


Exibit 2: Segments of Indian Nutraceutical Market

As nutraceutical regulations are evolving in India, it is a possibility that some of the content is conflicting / confusing. Yet, for the Indian industry to take shape, these have to be streamlined

In order to enter the Indian nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.

1. Product evaluation: In Indian conditions, the classification of formulations is very complex. Hence, due diligence in terms of carving a specific amount for each ingredient and the combination of ingredients becomes very crucial.

In order to assess a product as per the Indian regulations, it is very important to examine each active ingredient and additive in the context of permissibility, standards and dosage of vitamins/minerals allowed as per the therapeutic, prophylactic or recommended daily allowance for Indians. Manufacturers are also unclear whether their products will be classified as food or food supplement or drug in the context of the Prevention of Food Adulteration Act, 1954 and Rules, 1955, Food Safety and Standards Act, 2006 and Drugs and Cosmetics Act, 1940 and Rules, 1945.

The Food Safety and Standards Rules, 2011 highlights the regulatory enforcement structure and procedures which the Central Government proposes to create. The structure has a hierarchy beginning from the commissioner of food Safety to a number of officers like designated officer, food safety officer, food analyst, etc. who will be involved in the product analysis process at different points.

Various steps in the product analysis include

  • Developing extracts of documents and authenticating the same by the concerned authority
  • Sample collection (in the presence of witnesses)
  • Sample dispatch to the concerned authority (different processes for bulk package and single package)
  • Food analysis
  • If analysis is not complete within the stipulated period of time, further action plan by the designated officer
  • Adjudication proceedings (holding enquiry, appeal procedure, hearing, etc.)

2. Licenses: Though the new FSSA promises to simplify the licensing and registration processes for nutraceuticals, the actual process varies as per the number of parameters. To get a product registered in India, number of licenses (almost 4 – 5) might be required, depending on the actual product status like

  • Whether the company wants to sell bulk drug or finished formulation
  • Whether the company is importing finished product or bulk goods?
  • Whether product to be imported is with or without India specific label?
  • Will the claims be developed in India?
  • Whether the company has a packaging license?
  • Whether it requires manufacturing license?
  • Whether it requires marketing license?

Number of documents will have to be furnished by the food importer to the government authority alongwith registration application dossiers

Interlink, through its regulatory product portfolio, provides regulatory support related to these licensing procedures for

  • Import licensing
  • Manufacturing licensing
  • Marketing licensing and
  • Other state and national level clearances/licenses required from the regulatory side, which need to be taken care of before launching these products in India.

3. Health and label claims: Developing health and label claims, specific to Indian regulatory guidelines, is a major element to be considered while entering the Indian market. International as well as national clients have number of questions about

  • India specific labelling and packaging requirements
  • Packaging of the consignment composition of the consignment and approach to market the same
  • Need for sample material and declaration for registration
  • Label content and claim
  • Structure – function claim

Based on the regulatory assessment of the product, India-specific label content and claims needs to be developed. New entrant should also consider the requirements to be met, to make specific product claims

Conclusion

Globalisation of the nutraceutical and functional food industries present significant challenges to stakeholders, not the least of which is the regulatory variance between countries active in the marketplace. Nutraceuticals are playing an important role in the development of future therapeutics but it depends on the control of purity, efficacy and safety. Hence, when any new entrant wants to enter the Indian nutraceutical market, it is very important to comply with the regulatory framework, so that the business is run smoothly. The focus areas should be product evaluation for each active ingredient in the context of permissiiality, standards and dosage of vitamins/minerals allowed, product classification as per various Indian healthcare laws (legal definition of the product), India-specific label claims and advertising.

References:
i. Ministry of food processing industry website
ii. The Food Safety and Standards Act, 2006 – Bare act with short comments, 2009, Professional Book Publishers, Delhi.
iii. Nutraceuticals – Critical supplement for building a healthy India, 2009, E&Y – FICCI report
iv. Industry Insight – Nutraceuticals, August 2010, Cygnus Report.
v. Interlink Knowledge Bank
vi. Expert Interviews
vii. Global Nutraceutical Industry: Investing in Healthy Living, Frost – FICCI report, 2011
viii. Chaturvedi, S. et al (2011), Role of Nutraceuticals in Health Promotion, International Journal of PharmTech Research, Vol. 3, No.1, pp 442-448

(For further queries write to ruth@interlinkconsultancy.com)

Be Sociable, Share!

Pages: 1 2 3