In India, (Food and Drug Administration) FDA License is mandatory certification for the authorized business to manufacture, import, or sell food, drugs, and medical devices. The license is issued by the Central Drugs Standard Control Organization (CDSCO) or State Drug Authorities. The License of FDA ensures compliance with the regulations of the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, ensuring safety, quality, and efficacy standards.
So to obtain an FDA License in India for better regulation is necessary. Here you will find details about the FDA license process, documentation and details that you need to understand.
What Is FDA License? [Food and Drug Administration]
In easy words, an FDA License in India guarantees the quality and safety of the products. This Food and Drug License is very important as it protects public health and approves the selling of various types of products in the market. It works as a trust that consumers feel after seeing the FDA approval written on the products. This process involves certain types of document submissions, inspections, and many more. The Food and Drug Administration license is essential for businesses that work for manufacturers and distributors and sell their products in India.
Why FDA License Is Required? [Food and Drug Administration Requirements]
The FDA license is necessary for those who are willing to deal with various items in the market such as cosmetics, medical, drugs, & food. It is necessary for the manufacturing and producing industry. So the license is required for various reasons such as:
- Ensure Compliance – It shows the product that is manufactured in your production house adheres to the regulatory standards of safety, quality and efficacy.
- Protect Public Health – Through this, you can showcase your product and prevent the distribution of substandard or counterfeit products.
- Legal Requirements – This is a legal requirements that help and operate them legally within the Indian Market.
- Consumer Confidence – This will help you to build trust in the quality of the products being offered.
Advantages of Food and Drug Administration License In India
FDA accreditation has several advantages that are beneficial to consumers and companies alike. The main benefits are mentioned below:-
- Guarantees Product Safety: An FDA certification means that a product has passed stringent testing and assessment to guarantee that it is safe for usage by consumers. This guarantee is essential for safeguarding the general public health and stopping the spread of dangerous or inferior goods.
- Boost Credibility and Trust: companies who have obtained FDA certification show that they are dedicated to meeting quality standards and following regulations. This increases their marketability and fosters confidence among stakeholders, healthcare providers, and consumers.
- Facilitates Market Access: FDA permission is needed for selling in markets, both nationally and internationally. By providing business permits to new markets and opportunities, FDA certification helps in the growth of market reach and growth potential.
What Are Required Documents For FDA License?
These are the very important papers needed for FDA License Registration; look at below:-
- Proof of Business Entity – Incorporation certificate, partnership deed, etc.
- Premises Details – Address proof, layout, and inspection of manufacturing unit or warehouse.
- Qualifications of Responsible Person – For manufacturers, qualifications and experience of the technical staff (e.g., pharmacist).
- Manufacturing Process Detail – For manufacturing licenses.
- Certificate of Free Sale – For importers (indicating the product is freely sold in the country of origin).
- Quality Control Documents – GMP certification, quality assurance protocols.
- Safety Data – Required for drugs and medical devices.
- Form Submission – Specific forms, such as Form 27 for drug manufacturing, must be filled out and submitted.
Procedure For Obtaining an FDA Certificate
Obtaining an FDA (Food and Drug Administration) certificate involves several steps that depend on the product type, such as food, drugs, medical devices, or cosmetics. So, here are the easy guidelines for you to apply for an FDA license in India:
Step 1 – Determine the Product Type and Regulatory Pathway
Identify your product category whether it is food, drug, cosmetic, medical device, biologic, or dietary supplement. As per the FDA regulatory understand the classification and requirements for your specific products.
Step 2 – Product Development and Compliance
Get to know about the product you are going to deal with in the market just like:
1. Drugs and Biologics – Conduct preclinical research and clinical trials (phases 1, 2, and 3) as per FDA’s Good Laboratory Practices (GLP).
2. Medical Devices – Classify your device (Class I, II, or III) and follow applicable regulatory pathways such as 510(k), De Novo, or PMA (Pre-Market Approval).
3. Food and Dietary Supplements – Ensure compliance with food safety standards, including labeling and ingredient safety.
4. Cosmetic – Adhere to safety guidelines and proper labeling.
Step 3 – Register Your Establishment
For all the FDA regulated products regietr your establishment for the FDA Establishment Registration System (FURLS). Pay the applicable registration fee.
Step 4 – Prepare and Submit Relevant Applications
As per your product preperate the application and submit to the relevant department. Such As:
1. Drugs/Biologics – Submit an IND (Investigational New Drug) application for trials or NDA (New Drug Application) for approval.
2.Medical Devices – File a 510(k) notification, PMA, or exemption request as per device classification.
3. Food and Dietary Supplements – Follow the FSMA (Food Safety Modernization Act) regulations and submit necessary documents.
4. Cosmetics – Though not pre-approved, maintain records for safety compliance and adhere to labeling rules.
Step 5 – Perform Required Testing and Inspections
Conduct a test for the safety and efficacy of drugs, medical devices and biologics. Allow FDA inspections of your manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP).
Step 6 – Labeling Compliance
Ensure that your product adhere to the FDA labelling compliance and add all the details including warnings, usage instructions, and ingredient lists. Verify compliance with the FDA’s Unique Device Identifier (UDI) requirements for medical devices.
Step 7 – Submit the Application for FDA Certificate
Once your product meets all regulatory requirements, apply for the relevant FDA certificate.
Step 8 – FDA Review and Approval
When you apply then FDA will review all your documents and application information when they find it all correct they will issue the license. If somehow they find any omission then will inform you to fill all the errors.
Step 9 – Maintain Ongoing Compliance
After obtaining the FDA certificate, adhere to ongoing compliance requirements, such as periodic audits, adverse event reporting, and renewal of licenses.
Who Can Get an FDA License?
The FDA, called the Food and Drug Association, verifies many products; this procedure helps ensure products meet all the standards before soldering in markets. A list of the items is given below:-
- Drug – Medicines, whether it is prescription or over-the-counter, to treat diseases, manage symptoms, and handle illness. This comprises antibiotics, painkillers, and vaccines.
- Tobacco Products – Cigarettes, e-cigarettes, cigars, and all the tobacco items are also governed by the FDA.
- Medical Devices – Machines, implants, and software used for the therapeutic objective, like x-ray machines, pacemakers, or also special feature bandages.
- Food and Beverages – The FDA guarantees that safety and standards are followed by food, drinks containing additives, dietary supplements, and bottles of water.
- Cosmetic – Makeup, skincare, perfumes, and hair dyes FDA regulates these products.
- Biological Products – components that are made from living organisms, including vaccines, blood components, blood, and gene therapy.
Timeline Of FDA License In India
Basically, the FDA assigned 10 months to review drugs, whereas, under priority review, that time is reduced to 6 months.
What Is The Cost Of FDA Registration In India?
FDA Registration costs may vary according to different factors, what types of products you’re registering, and the difficulty of the reports. So, it’s advised that you consult the experienced staff in this department.
Validity Of Food & Drugs License In India
An FDA License is valid for a maximum of five Years from the date of issuance and must be renewed annually.
Why Choose ELT For FDA License?
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What Are The Consequences Of Not Providing All Necessary Documents To FDA?
If you forget to provide the documents, then it will fail and delay the FDA License.
Who should I contact if I have any questions about submitting the necessary paperwork?
You should contact the FDA’s regulatory affairs department or your designated FDA liaison if you have any questions about submitting necessary paperwork related to the FDA (Food and Drug Administration).
What Is an FDA Certificate Full Form?
The FDA’s full form is Food & Drug Association.
How Do You Get an FDA License?
1 – Examine the machinery with technology transfer specialists and scientists.
2 – Study different types of licenses accessible for online use.
3 – Give license application to agency-level FDA Technology transfer program.
Who Should Register With the FDA?
International and national organizations that re-pack, manufacture, and re-label drug items are mandatory to register with the FDA.