US FDA Certification in India

If you want to export items like food, drugs, cosmetics, medical devices, supplements, or even PPE kits to the USA, you need to get US FDA certification. The main goal of US FDA certification is to protect public health in the United States. The FDA ensures these products are safe and properly managed.

Established in 1906, the US FDA is a government agency operating under the Federal Food and Drugs Act. It's one of the world's oldest agencies for consumer protection. Getting US FDA certification is crucial and mandatory to expand your business into the USA.

After an inspection by an FDA official, they issue Form 483 for FDA certification of the items. Indian food and pharmaceutical manufacturing facilities must follow Current Good Manufacturing Practices (CGMP) according to FDA rules.

The FDA regulates a wide range of products including biological products, medical devices, cosmetics, prescription and over-the-counter drugs, veterinary drugs, tobacco products, and even radiation-emitting devices.

What is US FDA Certification?

US FDA Certification is a document that confirms your product is safe and effective for use. It shows that your exported items to the USA meet the Current Good Manufacturing Practices (CGMP) set by the FDA guidelines. In India, all businesses handling food, drugs, medical devices, and cosmetics must obtain this certification.

Not having US FDA Certification means you can't sell your products in the US market. The certificate provides important details about product standards, quality, and regulations. It also lists the recipient company's name.

Advantages of US FDA Certification in India

US FDA Certification is highly respected worldwide and offers several advantages:

1. Customer Trust: It builds trust among customers because earning this certification involves rigorous procedures like site inspections and detailed documentation. Customers believe in the quality and efficiency of certified products.
2. Increased Popularity: FDA-certified products gain popularity quickly because consumers recognize them as safe and well-tested. This leads to higher demand and positive word-of-mouth promotion.
3. Global Market Access: The certification opens doors to international markets beyond the USA, including Japan, UK, China, Australia, and more. It facilitates exporting products worldwide.
4. Business Expansion: Once certified, similar procedures can be applied to develop other products or enter new business sectors more easily.
5. Attracting Investments: Certification signals that your products meet high standards, making it easier to attract funds and investments from various sources.
6. Medical Sector Growth: FDA certifications are crucial for medical equipment and products. This certification enhances credibility within medical networks, where healthcare professionals prefer certified products.

These benefits make US FDA Certification in India a valuable asset for businesses looking to expand, gain consumer trust, and enter global markets.

Products in India Requiring US FDA Certification

It's important to note that not every product you want to export to the USA requires US FDA Certification from India. However, there are specific FDA-regulated products that cannot be exported without this certification. Here's a list of these products:

1. Food Products: Food items themselves don't need FDA Certification, but every facility in India that handles, prepares, or packages food for human consumption must have it. US FDA officials visit these facilities to ensure they meet FDA standards, including those for animal food products.
2. Medical Devices and Equipment: Medical devices are critical for health and safety, so the FDA classifies them into different categories:

·       Category 1 includes items like elastic bandages and face masks.

·       Category 2 includes products like wheelchairs and pregnancy test kits.

·       Category 3 includes complex devices such as pacemakers and heart valve replacements. All manufacturers of these devices in India must obtain US FDA Certification for each class.

3. PPE Kits: Personal Protective Equipment (PPE) such as masks and gloves, used to protect against infection, must also be FDA certified before export to the USA.
4. Supplements: Dietary supplements, which include finished products and their components, are regulated by the FDA to ensure they are safe and properly labeled. Manufacturers in India must obtain US FDA Certification for these products.
5. Drugs: Both prescription and over-the-counter drugs must undergo FDA scrutiny to ensure they are safe and effective for use by US consumers. Indian drug manufacturers need US FDA Certification to export these products.
6. Cosmetics: While most cosmetics don't need FDA approval before entering the US market, there are regulations to prevent adulteration. Indian businesses exporting cosmetics like moisturizers, fragrances, and makeup must comply with FDA standards and may require certification.

These regulations ensure that products entering the US market meet stringent safety and quality standards set by the FDA, protecting consumers' health and safety.

Products Exempt from FDA Approval

1.     Healthcare Providers and Laboratories: FDA does not approve physician offices or labs.

2.     Compounded Drugs: These are not FDA approved.

3.     Organ Transplants: Vascularized human organ transplants like kidneys, livers, and hearts are not FDA regulated or approved.

4.     Tobacco Products: These are not approved by the FDA.

5.     Cosmetics: Except for color additives (excluding coal-tar hair dyes), FDA does not approve cosmetics.

6.     Medical Foods: FDA does not approve these.

7.     Infant Formulas: These are marketed without prior FDA approval.

8.     Dietary Supplements: These do not require FDA approval.

9.     Food Labels: FDA does not approve food labels, including Nutrition Facts labels.

10.  Structure-Function Claims: These claims on dietary supplements and foods do not require FDA approval.

These products may have other regulations or guidelines they must follow, but they do not go through the FDA approval process.

The Consequences of Misusing the FDA Logo

The FDA logo is meant only for official government purposes. It should not be used in a way that changes how people see the FDA or suggests the FDA supports a private company, product, or service.

The FDA logo is strictly for the U.S. Food and Drug Administration to use. It should not appear on materials from private companies.

Using the logo in this way could wrongly make it seem like the FDA approves of a private company, its work, products, services, or people. This isn't true.

Using the FDA logo without permission breaks federal law. It could lead to fines or criminal charges.

Why US FDA Certification Matters in India?

US FDA Certification in India enables you to legally sell your products in the USA and other countries.

The cost of certification is minimal compared to the benefits it provides.

Having US FDA Certification in India helps build strong trust among Indian consumers, making your brand highly credible.

Whether you need guidance on categorizing your device or obtaining US FDA Certification, establishing a relationship with the FDA is essential to bring your product to market.

 

Why US FDA Agent is Important for US FDA Certification in India?

When applying for US FDA Certification, all foreign food, medicine, and medical device makers and exporters from India must appoint a US FDA Agent. This Agent serves as the main link between your business in India and the FDA in the USA. They handle emergency contacts and routine certification requirements.

The US FDA Agent must be a US resident, have a physical presence, or be part of a registered firm in the United States. They cannot use a post office box as their address.

It's crucial that the US FDA Agent is available during business hours to answer calls or have someone who can do so on their behalf. This accessibility ensures smooth communication with the FDA throughout the certification process.

Important points when seeking US FDA Certification in India

The key aspects to keep in mind when applying for US FDA Certification in India

1. US FDA Agent Requirement: You need a full-time US agent based in the USA who can receive FDA communications and respond promptly on your behalf.
2. Drug Safety and Testing: Companies seeking FDA Certification for medicines must conduct safety and effectiveness tests in labs and on animals. They submit these results to the FDA for evaluation by medical experts.
3. Export Requirements: For products regulated by the FDA, US businesses often require FDA Certification when exporting to other countries or at the request of foreign governments.
4. FDA Registration: Organizations, both domestic and international, involved in manufacturing, repackaging, or relabeling medical products in the USA must register with the FDA. This includes declaring all supported medical products to maintain an updated database.
5. Cosmetic Registration: The Voluntary Cosmetic Registration Program (VCRP) is a post-market disclosure system for cosmetic manufacturers, importers, and distributors operating in the USA.
6. Electronic Submissions: FDA prefers electronic submissions through the FDA Unified Registration and Listing System (FURLS) for storing and managing data efficiently. This allows for online application and management of US FDA Certification from India.
7. Types of Certification Applications: There are four main types of drug certification applications:

·       Investigational New Drug (IND)

·       New Drug Application (NDA)

·       Abbreviated New Drug Application (ANDA)

·       Biologic License Application (BLA)

Required Documents for US FDA Certification in India

· Airway Bill & Invoice Bill of Lading: Details of shipment and invoice.

· Order for Purchase: Confirmation of buyer's intent.

· Specific Documentation for Each Commodity: Detailed paperwork for each product.

· List of Items to Consider: Checklist of shipment contents.

· List of Growers: Information about product origin.

· Labelling Copies: Copies of compliant product labels.

· Documentation proving product ownership.

· Declaration of product usage.

· Any other requested documents.

Feel free to reach out to our business advisors for a complimentary consultation to learn about the specific documents needed for US FDA Certification in clear, straightforward terms.

Process to get US FDA Certification in India

E-FounderIndia is a group of skilled professionals dedicated to helping you obtain US FDA Certification in India. Our experienced team can assist you throughout the entire process, from preparing documents to securing final approval for your application. We offer a range of services designed to elevate your business and enable global growth.

Sequential Steps for Achieving US FDA Certification in India

1. STEP 1: Consult with our experts to understand the product you want to export and trade in the USA.
2. STEP 2: Provide necessary documents and information for applying for US FDA Certification.
3. STEP 3: Our team will appoint an authorized US FDA Agent in the USA and submit your application to the FDA.
4. STEP 4: Once your business and application are verified by FDA officials, we will deliver your US FDA Certification in India.

Important Note: The verification process time can vary and depends on the US FDA Department and its officials.

How we Support You in Obtaining US FDA Certification?

Getting US FDA Certification in India is challenging, but e-founderindia makes it hassle-free. Our experts handle everything from connecting you with business professionals to managing document preparation, responding to objections, and more. You don't need to visit FDA offices in the USA or worry about administrative tasks like registrations and certifications. Our team of Chartered Accountants, Company Secretaries, and Lawyers uses advanced technology to ensure your business meets all legal requirements efficiently. We treat your business like our own and aim for excellent results with minimal effort on your part. Contact us anytime for affordable and reliable support from the comfort of your home. Top of Form