Everything you need to know about Nutraceutical Manufacturing in India

July 8, 2022 Spread the awareness:

Nutraceuticals are food supplements used for growth, repair of body tissues, and well-being. The food habits of most people today are poor and they lack a balanced diet. This leads to a lack of essential nutrients in the body and causes deficiency syndrome. Since many diseases can be prevented with the right nutrition. Nutraceuticals help stay fit and healthy by providing the right kind of nutrition.

Owing to the increasing health consciousness of the people, the market for Nutraceutical manufacturers in India[SJ1] has grown tremendously in recent years. The value of the nutraceutical market in India in the year 2017 was 260 billion Indian rupees and this is estimated to grow up to 650 billion rupees by the end of 2022. This high growth in the market value is a result of demand that calls for large-scale nutraceutical manufacturing in India. The nutraceutical market in India is one of the fastest-growing markets for nutraceuticals in the Asia-Pacific region. 


Demand or market share of different nutraceuticals


According to research, nutraceutical manufacturers in India manufacturing vitamins and minerals hold a large chunk of 36% share in the Indian nutraceuticals market. This is followed by probiotic supplements and omega-3 fatty acids, with a share of 9% and 5%, respectively. The remaining percentage of the market is occupied by amino acids, fibers, peptides, plant extracts, and antioxidants.


FSSAI Guidelines for Nutraceutical Manufacturers in India

Until very recently, Nutraceuticals meant any product derived from food sources that provide health benefits apart from basic nutrition. But this was very generalized, and it did not differentiate between a food item and a drug. 

Now that there is a separate regulation for nutraceuticals, the nutraceutical manufacturers in India have to stick to the new FSSAI (Food Safety and Standards Authority of India) standards. FSSAI has laid out certain standards that the Nutraceutical Manufacturers in India will need to confer to. They may use only any of those ingredients in the manufacturing of the nutraceuticals that are mentioned in the following schedules:


Schedule I- a list of vitamins and minerals

Schedule II- a list of essential amino acids and other nutrients that FSSAI approves

Schedule IV- a list of plant-based or botanical ingredients

Schedule VI- a list of ingredients that can be used as nutraceuticals

Schedule VII- a list of strains of microorganisms that can be used to produce probiotics 

Schedule VIII- a list of prebiotic compounds

 

FSSAI Guidelines for Nutraceutical Manufacturers in India regarding daily usage value



The Nutraceutical Manufacturers in India must ensure that the nutrients must be added only as per the recommended daily allowance (RDA). This RDA has also been specified by the Indian Council of Medical Research (ICMR) or the Codex Alimentarius Commission (the international food standards body). However, since not everyone is aware of the RDA, it is a great responsibility on the shoulders of the Nutraceutical Manufacturers in India to adhere to the amounts prescribed. 

Nutraceutical Manufacturers in India should not use any ingredient other than those specified in Schedule VI. These can also be used as nutraceuticals only when the marker compound and the daily usage values are specified. Also, suppose the Nutraceutical Manufacturers in India use a plant-based ingredient, they may be used either in the prescribed pure form or their extract, and the extracted ratios must adhere to the daily usage value.

Suppose there is an ingredient for which India or an International controlling organization has not laid out the daily minimum and maximum usage levels. In that case, the food business operator shall adopt the usage level based on relevant scientific data. They must retain the documentary evidence of such data according to which they used the nutraceutical ingredient. They may be called upon to submit the documented scientific data to the Food Authority.

If additives are added to nutraceutical formulations, the Nutraceutical Manufacturers in India can only use those additives specified in Schedule VA or Schedule VE, or Schedule VF in the nutraceutical regulation.

 

Labeling instructions for Nutraceutical Manufacturers in India:

The nutraceutical food packet must carry the following information on the label:

  • the word “NUTRACEUTICAL” to indicate its kind
  • a common name of the nutraceutical through which it will be recognized
  • the amount of each nutraceutical ingredient used in the product that may have a nutritional or physiological effect on the consumer
  • If applicable, the label must also indicate the number of nutrients expressed in terms of the percentage of the RDA. 
  • an advisory warning stating ‘not to exceed the recommended daily usage.’ 
  • other advisory warnings as per requirement
  • Any other precautions, known side effects, etc
  • The statement instructs the product to be stored out of reach of children.

All Nutraceutical Manufacturers in India adhere to these rules, and that is how their nutraceuticals get approved for sale in India by the FSSAI.[SJ1]  As the lifestyle and the food habits of the people are consistently poor and their health consciousness keeps increasing every day, a large chunk of the population will take to consuming nutraceuticals to elevate their health.

About ZIM Laboratories

ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (immediate, sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).

 

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