Registration of Dietary Supplement in India

Registration for dietary supplement from the FSSAI authority is mandatory to get entry in the market of India. There are various procedure which is given by the FSSAI to follow to get registered as a dietary supplement in India. Because of the stringent rules and regulation its becoming very difficult for the companies to get approved their dietary supplement. But for the proper public safety it is required to follow all the guidelines and regulation of registration procedures. Various forms like FORM A and FORM B has to be filled and get approved to place their product in the market. Following is the chart of procedure to get the approval:

There are various rules given by the FSSAI to be followed for the registration and licensing of food products like nutraceuticals and dietary supplements. They also have given various claims regarding the label and packaging and various standards and their limits of additives are also mentioned. Hence all the standards has to be maintained to get their product approved. Hence there are various departments from the production to distributors.

FSSAI regulations, 2011, frames that:

a) For the registration form A/B has to be filled for the manufacturing in india according to sch-1

b) If personnel need import license then it has to be issued from the Central Licensing Authority.

Following documents are needed for the approval:

  • Form A
  • Declaration form which has to be self attested
  • Manufacturing/ import license –
  • Form B and form C
  • Declaration form which has to be self attested
  • and the below document copies

Documents to be enclosed with new application for license / import license to State / Central Licensing Authority

  • Form-A, Form-B, Form-C
  • Layout of the manufacturing unit even blueprint can be submitted. Blueprint/layout plan of the processing unit
  • List of Directors
  • List of the machines which are used in manufacturing with its name.
  • Photo I.D with the proof of address
  • List of food category which is to be manufactured.
  • Authority letter with name and address of responsible person
  • NOC & Copy of License from manufacturer
  • Food Safety Management System plan or certificate (if any)
  • Source of milk or procurement plan for milk including location of milk collection centres
  • Source of raw material
  • others

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