Certification & Licensing-FDA license

What Is FDA license in India?

FDA license is issued by the FDA (Food and Drug administration), an agency of the United States of America. The FDA is the oldest consumer protection agency in the United States. The FDA is entrusted with the responsibility of protecting public health by providing food and drug license to assure the safety and security of a variety of products, like biological products, medical devices, cosmetics, veterinary drugs, tobacco, and other products that emit radiation. FDA provides various kinds of certificates, and its certification is mandatory for products to get entry into the US market.

Types Of FDA Licenses In India

There are many products that need FDA certification. Below is a list of some products that need FDA certification -

FDA Certificate For Food Products: Actually, food products don’t require any kind of FDA License; only food facilities require it. FDA officials visit and conduct thorough inspection of the food plants in India to issue food and drug license. FDA officials examine whether food plants are complying with prescribed standards set by the FDA.

FDA Cosmetic Certificate:  Cosmetic products and companies don’t necessarily require FDA license. In certain cases the FDA regulates cosmetic product as a drug product, which may require cosmetic products to get FDA manufacturing license. 

FDA Drug Certificate: FDA examines whether any particular drug adheres to the Over-the-counter (OTC) monograph. OTC monograph tells us about conditions in which the drug products are safe and effective for use. If any drug is not complying with the OTC monograph, then it will require FDA manufacturing license.

FDA Certificate For Medical Devices: The FDA classifies medical devices into three classes, namely Class I, Class II, and Class III. Medical devices that are placed in class III, are regarded as highly risky devices. Devices such as pacemakers, breast implants, and replacement heart valves, etc. fall in class III and necessarily requires FDA certification.

Advantageous Of Having An FDA Manufacturing License

There are many benefits of getting an FDA certificate. A few of them are mentioned below -

Increase Demand Of The Product: FDA certification can boost the demand of your products because consumers believe that products with FDA certification are tested and safe to use.

Access To International Markets:  FDA approval provides an international standard to your product. FDA approved products can be sold in the markets of different countries of the world.  

Enhance Reputation Of The Brand: Food and drug license enhances the credibility of the brand because the FDA has international recognition. Having FDA approval itself tells about the standard of a product, which helps in establishing the product in the international market.

Opens Ways For Funding: FDA manufacturing license certifies that the manufacturer follows high level of standards in production. It will draw the attention of many big companies and investors towards the product for investment.

Documents Required for FDA License In India

A list of required documents is as follows:

Essential Documents:

• Bill Of Lading
• Airway Bill
• Invoice
• Purchase Order

Commodity-Specific Documents (As Applicable):

• Packing list
• Copies of labelling
• Documentation stating the manufacturer of the product
• Analysis certificate
• Intended use statement/end use statement of the product

Complete Process Of Obtaining FDA Manufacturing License

Here is the complete process of FDA Certification: -

• First of all, FDA officials conduct a visit to the food and drug plants in foreign countries.
• After inspection, the officials of the FDA issue the Form 483 to the manufactures of the products.
• If FDA officials find any kind of deviations from FDA standards, then it should be mentioned in Form 483.
• If there is any variation from regulatory standards, then it will be mentioned in Form 430.
• After that, these variations are discussed with the management of the company.

The FDA also issues an EIR (Establishment Inspection Report) in order to complete the process of FDA Manufacturing License. The procedure is given below -

• Pre-Clinical Testing
• Investigation of New Application
• FDA Review

You should submit Form 438 to the FDA within 15 working days. If the FDA officials are not satisfied with your response to Form 438, then they can issue a warning letter. You will have the time of 15 working days to submit your response to the warning letter. An inadequate response could result in the cancellation of FDA manufacturing license, import alert for products, and withholding of FDA approval.

Finally, if the FDA officials are satisfied with your response, then you will receive approval of FDA. In many cases, for any kind of particular drug, FDA officials may directly issue a warning letter without even giving you Form 438.

Why choose servicesplus

 FDA manufacturing license will not only provide you with the opportunity of exporting your product to the USA market, but it also helps to establish your brand in the international market. Everyone who wants to establish his brand in the international market, strives for FDA certification. One can easily apply for FDA license registration online, but the complex legal and technical process involved in getting the FDA approval make it difficult for many to get it. At servicesplus, we have a team of experts that will provide you handholding support in the complete process of FDA approval.

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