FSSAI License

How to Get FSSAI License for Pharmaceutical Companies?

calendar11 Nov, 2022
timeReading Time: 4 Minutes
How to Get FSSAI License for Pharmaceutical Companies?

In the present scenario, Pharmaceutical Companies play the most vital role in India; a large number of pharmaceutical companies are registered in Marketing, Manufacturing, Distribution, and Trading sectors. These companies produce drugs in various forms, such as vaccines, pills, tablets, etc. India is one of the large producers of vaccines on the globe. All pharmaceutical companies should undergo a process to obtain an FSSAI License for the foods they produce in their Pharmaceutical Companies. In this write-up, we will discuss how to obtain FSSAI License for Pharmaceutical Companies in India.

Why is it necessary to get FSSAI License for Pharmaceutical Companies in India?

FSSAI or Food Safety & Standard Authority of India, supervises & regulates the standard and safety of food in India. It mandates that every business concerning food must undergo FSSAI Registration. These businesses can be food packaging, delivering, preparing, serving & relating. So, whatever may be the business or industry type, it should undergo FSSAI Registration if it deals with food items.

Even though Pharmaceutical Companies hold Drug License for the trading, distribution, production, and marketing of food supplements or nutraceuticals. FSSAI mandates that the Company must get an FSSAI Certificate for Nutraceutical products or items. Food supplements or nutraceuticals are substitute which gives nutrients, fatty acids, vitamins, and proteins to our body in the form of doses, tablets, and pills.

Different Types of FSSAI Registration in India

FSSAI Registration is based on business turnover, types, and production capacity. Depending upon the installed capacity & turnover. Food Business Operators are eligible for License such as:

  1. FSSAI Basic Registration: Food Business Operators having a turnover of less than Rs. 12 lakhs per annum must get FSSAI Basic Registration. The application form that the applicant has to file to get FSSAI Basic Registration is Form-A.
  2. FSSAI State License: Food Business Operators (FBOs) having an annual turnover of more than Rs. 12 lakhs per annum & less than Rs. 20 crores per annum must obtain the FSSAI State License. The Registration form that the applicant has to fill out to get an FSSAI State License is Form B.
  3. FSSAI Central License: Food Business Operators having a turnover of more than Rs. 20 crores per annum must get the FSSAI Central License. The Registration Form that the applicant has to fill out to get FSSAI Central License is Form-B.

Benefits of FSSAI License for Pharmaceutical Companies in India

The following are the benefits of an FSSAI License for Pharmaceutical Companies:

  1. If any Pharmaceutical Companies have FSSAI License, then the Company build more trust and confidence in the customers than the other companies who don’t have FSSAI License.
  2. FSSAI logo is a sign of high quality and it creates awareness among customers to consume high-quality foods. Food Businesses will also get a wider customer base after getting an FSSAI License.
  3. This License helps to expand the food business. You can start outlets or branches of your companies in various parts of India after getting FSSAI License. With this License, you can get bank loans easily for business expansion.
  4. This License gives legal & unique status to your business. It establishes a different identity that customers will know. FSSAI Logo will help to build a brand name within a short time. Customers will come to know about your products & brand when you have the FSSAI License.
  5. It helps in making your food business more popular. It also helps you grow your business widely in many states of the country. Profits of your food business will increase day by day after getting this License.

Documents Required for FSSAI License for Pharmaceutical Companies

Following are some vital documents required for FSSAI License for Pharmaceutical Companies:

  • Documents for Basic FSSAI Registration:
    • Photo id proof of the Food Business Operators.
    • Business Certificates such as Certificate of Incorporation, Shop & Establishment License, Partnership Deed or other Business Registration Certificates.
    • Food Safety Management System Plan.
    • Proof of possession of business premises or units, i.e., NOC from the owner of the rented premises, rental agreement, utility bills, etc.
    • Information on the bank account.
    • List of food items processed or manufactured.
    • Supporting documents (if needed) such as Health NOC, NOC by Panchayat or Municipality, and copy of License from the manufacturer.
  • Documents for FSSAI State License:
      Duly signed and completed Form-B.
    • Plan of processing unit stating the dimensions & operation-wise area allocation.
    • Authority Letter from the manufacturer nominated a responsible person’s name & address.
    • Copy of Certificate obtained under Multi-State Coop Act, 2002[1] or Coop Act, 1861.
    • List of Partners or Proprietor or Directors with photo id, contact details & address.
    • Analysis report of water to be used in the process to confirm the portability.
    • Name & list of equipment and machinery used with the number and installed capacity.
  • Documents for FSSAI Central License:
    • Duly signed and completed Form-B.
    • Name & list of equipment and machinery used with the number and installed capacity.
    • List of Partners or Proprietor or Directors with photo id, contact details & address.
    • IEC documents issued by DGFT
    • Authority Letter from the manufacturer nominated a responsible person’s name & address.
    • Certificate from Ministry of Tourism
    • Declaration Form
    • Supporting document for proof of transportation & turnover.
    • Analysis report of water to be used in the process to confirm the portability.
    • NOC or PA document issued by FSSAI
    • Ministry of Commerce Certificate for 100% EOU.

Procedure for FSSAI License for Pharmaceutical Companies

Following is the step-by-step procedure for FSSAI License for Pharmaceutical Companies:

  1. First, get your business plan;
  2. Then, determine your annual turnover.
  3. After that, the applicant needs to determine which type of FSSAI License is required for your Pharmaceutical Companies.
  4. Once the applicant determines the type, then they need to fill out the application & complete documentation.
  5. After filing the application, submit it along with the requisite fee. You should be careful if there is any incorrect information in the FSSAI application. FSSAI may cancel your Registration. If there is any change in the application form, then it must be updated.
  6. After the verification of the application and documents, the authority will issue the FSSAI License for Pharmaceutical Companies.

Validity of FSSAI License for Pharmaceutical Companies

The validity of an FSSAI License for Pharmaceutical Companies is between 1 to 5 years. The applicant can choose the validity of the FSSAI License for Pharmaceutical Companies as per their business requirement. For any reason, there shouldn’t be a delay in renewal; it must be done soon before the validity period expires.

Conclusion

FSSAI License in India varies as per the location of the premises & you can obtain FSSAI License for every premises where you are conducting business. FSSAI has made FSSAI License for Pharmaceutical Companies in India compulsory because it ensures food quality & covers a large base of food products from pharmaceutical companies.

Read Our Article:FSSAI Food License: Everything You Need to Know

Karan Singh

A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

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