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FSSAI Registration for Pharmaceutical Company – Process, Eligibility, and Documents Required
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FSSAI Registration for Pharmaceutical company

Pharmaceutical firms currently play the most important role in India; many of them are registered in the marketing, manufacturing, distribution, and trading sectors. These businesses manufacture medications in various formats, including pills, tablets, and vaccinations. One of the world’s major vaccine manufacturers in India. A procedure for obtaining an FSSAI License for the meals they make in their pharmaceutical firms. In this article, we’ll go through how Indian pharmaceutical companies may get an FSSAI licence.

Basic FSSAI Registration

The Food Safety & Standard Authority of India, often known as FSSAI, oversees and controls India’s food standards and safety. Every firm that deals with food are required to go through FSSAI Registration. These companies may deal with food packaging, delivery, preparation, serving, and relationships. Therefore, if a firm or industry works with food products, it must go through FSSAI Registration.

Even though pharmaceutical companies have a licence to trade, distribute, make, and promote nutraceuticals and food supplements. The Company is required by FSSAI to get an FSSAI Certificate for any dietary supplement goods or commodities. Nutraceuticals, often known as food supplements, are a replacement that provides our bodies with vitamins, proteins, fatty acids, and minerals in the form of dosages, tablets, and pills.

FSSAI Registration for Pharmaceutical Company?

Pharmaceutical company FSSAI license- All food business operators in India who conduct food business operations must apply for an FSSAI licence. A food company operator can choose which FSSAI License to apply / Food License to apply based on a number of parameters, including the yearly revenue of the business, the nature of the firm’s food activity, the production capacity per day, and many more. According to the above mentioned considerations, the FBO must apply for the following types of food licences:

 

1)    Basic FSSAI License / FSSAI Basic Registration :

For new businesses and small company owners in the food industry, a Basic Food License is necessary. A basic food licence can be applied for if the food business has an annual revenue of up to 12 lacs.

The basic FSSAI licence is for tiny enterprises or small businesses, such as tea stalls, small snack or pakora shops, small retailing firms, dhabas, temporary stall holders, and petty snack retailers, according to revised Foscos FSSAI License requirements. All food business owners who have or anticipate having an annual turnover of more than 12 lacs require a larger FSSAI licence, such as an FSSA state licence or an FSSA central licence, rather than an FSSAI basic registration. FSSAI registration online just needs a few papers, including a pan card, an Aadhar card, and documentation of the company location (such as a lease, an electricity bill, a sale title, etc.). The registration takes 7–10 days to process in total.

2)    FSSAI State License :

For food industry operators with annual turnovers of more than Rs. 12 Lac and up to Rs. 20 Crores, a state FSSAI licence is necessary. A manufacturer of food may also apply for an FSSAI State licence if their daily production capacity is up to 2 metric tonnes.

According to updated Foscos FSSAI License guidelines, a FSSAI State licence is the appropriate category to apply for a FSSAI licence for a business like a transporter, manufacturer, wholesaler, distributor, restaurant, caterer, warehouse, storage, supplier, etc. that produces up to 2 metric tonnes of goods per day. The number of documents needed for an FSSAI licence is greater than for an FSSAI basic registration. 15 to 20 days are required for the entire registration process.

3)    FSSAI Central License :

For food industry operators whose yearly sales exceeds Rs. 20 Crore and manufacturing capacity exceeds 2 metric tonnes per day, an FSSAI Central License is necessary. If a food company operator is an importer, exporter, or has their own e-commerce platform, they must additionally apply for an FSSAI Central License.

FSSAI Central licence is the appropriate category to apply for a FSSAI licence for a business like Registered Place of Business if the food business operator has units in more than one State, Merchant Exporter, Importer, or food business operator having own E-Commerce Platform, according to new Foscos FSSAI License guidelines. There is no need to file for FSSAI Registration under the E-Commerce Category if any food company operator sells their food items through a third-party e-commerce platform like Amazon, Flipkart, etc. The amount of paperwork needed for a FSSAI licence state is greater than for a central registration. The entire FSSAI Food License application procedure takes 25 to 30 days.

 

Benefits of FSSAI Registration for Pharmaceutical Company FSSAI License

The majority of food business owners believe that applying for an FSSAI licence is a waste of money and that having an FSSAI registration is useless when operating a food business. This hypothesis is entirely false, and anyone operating a food company has to apply for a food licence with the FSSAI Authority. The advantages that come with having a FSSAI License for a food business are numerous.

In order to appreciate the significance of a FSSAI licence when operating a food business, the following are some of the most significant advantages:

  • Food employment requires a FSSAI licence.
  • In comparison to businesses without an FSSAI number, if an industry has a licence from the agency, the company gains market credibility.
  • You cannot sell your food products on e-commerce sites like Flipkart, Amazon, Zabong, etc. without a FSSAI licence.
  • If you operate a food company without a FSSAI licence, you must pay a fine of Rs. 5 lakh and serve at least six months in jail.
  • If you have FSSAI, it indicates you abide by all of its guidelines. For instance, the workplace is clean and all of the employees are healthy and free from sickness.
  • You may put the FSSAI emblem on your packaged foods if you have a licence; otherwise, you may not.
  • With the FSSAI licence, expanding your firm into new markets won’t present any problems.
  • Your organisation must have an FSSAI licence in order to import and export food products.

 

FSSAI License Fees / FSSAI Registration Fees

The cost of the FSSAI licence is split into two parts. 1) The government fees, and 2) the expert fees charged by the government. An expert fee is charged by a professional to prepare all the necessary documents and get the application ready in accordance with the rules and regulations of the FSSAI License Authority. Government fees are listed on the government website and are fixed according to the type of business and type of food licence. The cost of a FSSAI licence for five years starts at Rs. 3,500 and varies depending on the type of business and licencing category. The MUDS payment policy is that 60% of the total FSSAI licence fee payment will be collected in advance, and the remaining 40% will be charged after the issuance of the FSSAI certificate.

The three categories of food licences are Basic FSSAI License, FSSAI State License, and FSSAI Central License. The following is a list of the FSSAI Government fees for the aforementioned food licence:

The following licences are available: Basic FSSAI License: Fees Annual turnover below 12 lakhs: 100; State FSSAI License: Fees Annual turnover over 12 lakhs but below 20 crores: 2000 or 5000; and Central FSSAI License: Fees Annual turnover beyond 20 crores: 7500

 

Documents Required for Pharmaceutical Company FSSAI license?

The following are the documentation needed for all three types of FSSAI registration:

For Basic Food License:

  • Form A has been signed by the company’s owner or another authorised signatory.
  • Photo identification for the business owner or authorised signatory, such as a PAN card or an Aadhar card.
  • Address verification from the business owner, partner, or authorised signatory, such as a voter identification card, passport, driver’s licence, etc.
  • Detailed information about the food goods that the business now deals with.
  • Email address and mobile number of the proprietor, partner, or authorised signatory. 
  • Business location proof of office and factory/unit premises, such as a lease agreement, an electricity bill, a water bill, a property tax bill, etc.
  • The trade name or legal name of the company for which they wish to get an FSSAI licence, registration, or food licence.

FSSAI Central License:

  •  Form B signed by the business’s owner or other authorised signatory
  • • Photo identification for the business owner or authorised signatory, such as a PAN card or an Aadhar card.
  • • Address verification from the business owner, partner, or authorised signatory, such as a voter identification card, passport, driver’s licence, etc.
  • • The partnership agreement or memorandum of association, the Certificate of Incorporation (COI) in the case of a partnership, the LLP, the Private Limited Company, or the Self Declaration in the event of a proprietorship
  • • Evidence of the business location, such as a lease agreement, an electricity bill, a water bill, a property tax bill, a conveyance deed or ownership document, etc.
  • •    specifics about the food goods that the company sells or creates.
  • • Water testing reports of the water used in manufacturing or the drinking water that attest to the water’s purity. • Sources of raw materials to be utilised, such as meat, milk, and so on.
  • • The Director General of Foreign Trade issues import export codes (IEC Codes).
  • • A No Objection Certificate (NOC), if any, issued by the municipality, panchayat, or local health agency.
  • • Form IX and the Board Resolution in the case of a Company-only situation.
  • Certificate from the Ministry of Tourism (in certain cases).
  • Records showing the number of cars and trucks owned by the carriers, as well as period-by-period turnover information.
  • A self-declaration document signed by the owner, partner, or authorised signatory

 

For FSSAI State License:

  • Photo ID of the owner/authorized signatory of the enterprise, such as a PAN card or an Aadhar card; signed Form B from the proprietor or authorised signatory of the enterprise.
  • Address FSSAI registration verification from the business owner, partner, or authorised signatory, such as a voter identification card, passport, driver’s licence, etc.
  • The partnership agreement or memorandum of association, the Certificate of Incorporation (COI) in the case of a partnership, the LLP, the Private Limited Company, or the Self Declaration in the event of a proprietorship
  • Evidence of the business location, such as a lease agreement, an electricity bill, a water bill, a property tax bill, a conveyance deed or ownership document, etc.
  • Exact information on the food goods that the company sells or manufactures.
  • Water testing reports of the water used in manufacturing or the drinking water that attest to the water’s purity. • Sources of raw materials to be utilised, such as meat, milk, and so on.
  • The unit’s FSMS plan, which specifies the size and space allotted for each operation.
  • A list of the machinery and equipment to be utilised, including with information on each item’s name, model, capacity, and installed numbers
  • The strategy in place for removing synthetic food products from the market
  • A No Objection Certificate (NOC), if any, issued by the municipality, panchayat, or local health agency.
  • Form IX and the Board Resolution in the case of a Company-only situation.
  • Certificate from the Ministry of Tourism (in certain cases).
  • Records showing the number of cars and trucks owned by the carriers, as well as period-by-period turnover information.
  • A self-declaration document signed by the owner, partner, or authorised signatory

Why FSSAI Consultant / Food License Agent is Important?

According to the norms and regulations of the FSSAI Authority, only the food business operator is permitted to create the papers and attach them to the application. The FSSAI application, what documents necessary for FSSAI registration consultant application. For instance, FBOs must upload the FSMS Plan, FORM IX along with the board resolution, Undertaking of Commercial Unit, Water test report, Blueprint and layout plan of the business premises, etc. when applying for an FSSAI Food License for a manufacturing unit. For these documents, specific formats have been created to prepare and upload the documents. If FBOs apply for a FSSAI License without the aid of FSSAI Consultants, their application will be rejected since they are unaware of the proper documentation and required forms.

The advantages of hiring a FSSAI registration specialist or consultant are as follows:

 

  • Help with the application for a food licence.
  • Aid in gathering the information and documentation needed to submit a food application. Documents shall be created in accordance with predetermined forms specified by FSSAI rules and regulations.
  • Help to speed up the document review and preliminary inspection processes so that the licence can be issued in 7 to 10 days. 
  • If you apply for a FSSAI licence without the assistance of a FSSAI licencing specialist, the minimum time frame specified in the FSSAI guidelines for issuing the licence is 60 days, and there is no maximum time restriction.
  • Updates on new rules and regulations are occasionally posted on the FSSAI portal.
  • Conduct an FSSAI audit and inspection of the food business’s facilities, and provide the food business operator with a checklist of requirements that must be met in order to avoid severe fines and incarceration.

Complete Process to Apply FSSAI Food License

The top FSSAI licencing specialist in India is MUDS, and they provide FSSAI services like FSSAI licences in Delhi, Delhi NCR, Gurgaon, Noida, and Ghaziabad, among others. The processes to apply for a licence are listed below; if you complete them, you will have the licence in your possession in 7–10 days.

Step I: The necessary paperwork must be completed and gathered in order to apply for a licence.

Step II: The experts at MUDS will carefully review all of the necessary paperwork. If all of the paperwork is deemed complete in every way, an advance fee will be required to apply for the licence.

Step III: Create the FSSAI licence application, upload the relevant files, and pay the government costs.

Step IV: The papers will be examined by the FSSAI officer after submission and payment on the FSSAI portal. The document review procedure will be finished once all the documents are present.

Step V: A FSSAI officer will inspect the location, examine the papers in person, and go through the other 45 items on the inspection report’s checklist. The Food Safety Officer will write an inspection report after reviewing the premises and upload it to the FSSAI portal.

Step VI: If the FSSAI safety officer concluded that everything was as stated in the FSSAI License application, he or she will sign off on the Inspection Report. If any differences are discovered, they must be reported and resolved.

Step VII: The Issuing FSSAI Officer will issue the FSSAI License if all inconsistencies are cleared up. As of the new FSSAI rules and regulations, you will only receive a soft copy of your licence; you will no longer receive a physical copy through courier or speed post. The FSSAI License can be printed out and displayed at a visible location for business.

 

License Renewal/ Food License Renewal

FSSAI food license for pharmaceutical company- The FSSAI licence is valid for the allotted time, which might be one year or five years. The owners of food businesses must renew the food licence prior to the end of that particular period. Every current food licence must submit a renewal application before the expiration date, in accordance with FSSAI rules and regulations for licence renewal. If the FSSAI License is not renewed within 30 days of its expiration, a late fee of Rs. 100 per day will be assessed. The existing food licence became null and void at the passing of the specified time period, necessitating the acquisition of a new FSSAI License or FSSAI Registration by the food company owners.

Documentation Required for FSSAI licence Renewal-

  • A photo ID for the owner or authorised signatory of the business, such as a PAN card or an Aadhar card, must be sent with the completed Form B or Form A.
  • FSSAI registration verification- Address verification from the business owner, partner, or authorised signatory, such as a voter identification card, passport, driver’s licence, etc.
  • The partnership agreement or memorandum of association, the Certificate of Incorporation (COI) in the case of a partnership, the LLP, the Private Limited Company, or the Self Declaration in the event of a proprietorship
  • Evidence of the business location, such as a lease agreement, an electricity bill, a water bill, a property tax bill, a conveyance deed or ownership document, etc.
  • Sources of the raw materials to be utilised, such as meat, milk, and so on. Water testing reports of the water used in manufacturing or the drinking water that validates the water purity.
  • The unit’s FSMS plan, which specifies the size and space allotted for each activity; A list of the machinery and equipment to be utilised, together with its make, model, capacity, and installation numbers; A strategy for recalling produced food items from the market.
  • A No Objection Certificate (NOC), if any, issued by the municipality, panchayat, or local health agency.
  • Form IX and the Board Resolution in the case of a Company-only situation.
  • Certificate from the Ministry of Tourism (in certain cases).
  • Records showing the number of cars and trucks owned by the carriers, as well as period-by-period turnover information.
  • A self-declaration document signed by the owner, partner, or authorised signatory

 

The Food License Officer reviews the FSSAI License Renewal Application once it has been submitted in order to determine whether or not all of the accompanying papers are authentic and comply with FSSAI licence standards. The FSSAI License Officer also inspects the food business’s location to ensure that all of the disclosed details, such as images and attachments, are in fact there. Officials in charge of issuing food licences also make sure that food business owners adhere to hygienic standards and the laws governing the production of food products. Your FSSAI License will be renewed if the Food License Officials are pleased with their enquiries and confirm that the rules and regulations of the FSSAI License are being adhered to strictly. Once more, the FSSAI License will only be renewed for a maximum of five years.

 

Food Licence Non-compliance

Penalty for violating the terms of an FSSAI licence:

 

The penalties for violating the terms of a food licence that the food business operator is determined to have done are as follows:

  • If a food business operator operates their firm without an FSSAI licence, they are in breach of the 2011 FSSAI Act’s regulations. The owner of a food business faces a maximum penalty of six months in jail and a maximum fine of Rs. five lakh, or both.
  • The Food Business Operator will be fined up to Rs. 5 lakhs if they are selling products that do not meet the quality requirements and regulations of their FSSAI License or FSSAI Registration.
  • The owner of a food business who sells a product bearing another company’s trademark is subject to a fine of up to Rs. 3 lakhs.
  • Anyone operating a food business that deals in the sale, purchase, storage, wholesale, distribution, or importation of food products containing foreign objects shall be subject to a fine of up to Rs. 1 lakh.

 

According to the type of infraction involved and the harm produced by violating the requirements, different punishments have been set forth in the act’s rules and regulations. If an FSSAI License or FSSAI Registration requirement is violated for which the punishment is not specified, the default penalty is a fine that may be increased to Rs. 5 lakh coupled with imprisonment, depending on the severity of the injury.

How Muds Management helps you in FSSAI Registration?

FSSAI license registration for pharmaceutical company- FSSAI License denotes approval or consent by the Food Safety Standards Authority of India, also known as the FSSAI Authority. The government agency that falls under the Ministry of Health is the FSSAI Authority. The owner of a food company in India is only permitted to operate after obtaining a licence. Every food business operator in India must have an FSSAI licence. In accordance with FSSAI regulations, even the owner of a tiny tea shop must submit an online application for a licence. There are three types of licences available under FOSCOS FSSAI, and they vary depending on factors including the company’s yearly revenue, daily production capacity, and kind of business, among others. Following application, the Food Operation Operator receives a fourteen-digit licence number that must be placed on the packaging of food items and displayed prominently in the place of business. FSSAI licences provide clients of food company operators assurance regarding adequate quality while reducing the amount of adulteration and inferior products. Only the two official websites of the FSSAI Authority exist for obtaining an Indian FSSAI licence: foodlicensing.FSSAI.gov.in and foscos.FSSAI.gov.in.

We, at MUDS, offer an online platform for FSSAI Food License Registration Consultants around Faridabad. We are reputable FSSAI registration consultant or authorised Food License Agents. MUDS has connections with more than 10,000 clients. The following are the distinctive services that we offer in relation to FSSAI Food License:

  •   Free professional counsel and the availability of your company’s name.
  • Pickup of the required paperwork from your location.
  • Creating and submitting an online FSSAI registration consultant application.
  • Assisting with the arrangement of papers that are not already in your possession, such as the Water Test Report, the Premises Blue Print, and other ad hoc documents.
  • Promptly communicate of latest updates and FSSAI Authority instructions.
  • Assisting and advising the food business operator during the FSSAI Inspection regarding the checkpoints, such as the premises must be clean and regularly sanitised, employees must be in good health and wear proper masks and gloves, raw materials, semi-cooked foods, and cooked foods must be stored in accordance with proper FSSAI guidelines, etc. that the food business operator needs to fulfil to pass the inspection.
  • Verify that you will provide the licence within 7 days of the application date.
  • Provide timely information on the renewal of FSSAI licences and food licences.

Conclusion

The type of FSSAI License required in India varies depending on the location of the premises, and you can apply for one for each place where you conduct business. Because it guarantees food quality and covers a wide range of food items from pharmaceutical firms, the FSSAI has made the FSSAI License for Pharmaceutical Companies in India mandatory.

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