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Natural Health Products (NHPs) Regulations and Licensing
Welcome to our comprehensive guide on NHPs regulations and licensing. Contact Satori OCS if you want to get a NHP Manufacturing License. We specialize in supporting makers and distributors of NHPs in negotiating the challenging environment of NHP licensing and regulatory compliances as a reputable consulting organization. Throughout the licensing procedure, we are here to offer professional advice and assistance whether you are bringing Herbal Medicines, Dietary Supplements, Homeopathic Medicines, Ayurvedic Formulations or Traditional Medicines to the Global or Indian Market.
What are Natural Health Products ?
Natural Health Products (NHPs) encompass a diverse range of products derived from natural sources, including plants/ herbs/ botanicals, animals, & minerals, and are intended to maintain or improve health and wellness.
Examples of NHPs include vitamins, mineral supplements, probiotics, dietary supplements, Homeopathic medicines, traditional medicines, Omega-3 fatty acid supplements, and herbal remedies such as Echinacea, Ginkgo biloba, and St. John's wort.
NHPs are designed to support or maintain good health. They are often used as complementary or alternative treatments for various health conditions and are believed to have fewer side effects than prescription drugs. They are commonly marketed as natural alternatives to prescription drugs, and are widely available over-the-counter.
The production and marketing of NHPs are regulated by government agencies to ensure their safety, efficacy, and quality. NHPs are subject to different regulations and must meet specific criteria for their composition, quality, and labeling, and must be manufactured in facilities that meet Good Manufacturing Practices (GMP) standards.
Classification of NHPs
NHPs can be broadly classified into different categories based on their ingredients, intended use, and therapeutic claims. Some common categories include:
These are NHPs derived primarily from plants or plant extracts and are commonly used in traditional medicine practices like Ayurveda and Unani.
Dietary supplements include vitamins, minerals, amino acids, and other substances meant to supplement the diet to maintain overall health.
Homeopathic NHPs follow the principles of homeopathy and are based on the concept of "like cures like."
Ayurvedic NHPs consist of herbal combinations or formulations that follow the principles of Ayurveda.
NHPs from traditional medicine systems like Siddha, Tibetan medicine, and folk medicine fall into this category.
NHPs Regulations
The regulatory requirements for natural health products vary depending on the country or region in which they are being sold. It's important to consult the specific regulations and requirements of each country or region where you intend to sell natural health products, as they can vary significantly.
- In Canada, NHPs are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under Health Canada.
- Manufacturers of NHPs must obtain a product license, which requires the submission of a detailed product license application, including information on the product's medicinal ingredients, source materials, potency, and recommended use. They must also have a
site license.
- NHPs must also have proper labeling and packaging. The product labeling must include specific information about the product's ingredients, directions for use, and safety information.
- NHPs are assessed for safety, efficacy, and quality before they can be sold to the public.
- Certain claims and health benefits must be supported by scientific evidence.
- In the United States, NHPs fall under the category of dietary supplements, which are regulated by the U.S. Food and Drug Administration (FDA). Dietary supplements must comply with the Dietary Supplement Health and Education Act (DSHEA) of 1994.
- Dietary supplements are not subject to pre-market approval by the FDA, but they must comply with labeling requirements and good manufacturing practices (GMPs).
- Manufacturers bear the responsibility for ensuring the safety and accurate labeling of their products.
- The FDA actively monitors these products for compliance with regulations and has the authority to take action against dietary supplements that are found to be unsafe or misbranded.
- In the European Union (EU), natural health products (NHPs) are regulated as food supplements or herbal medicinal products, depending on their intended use and composition.
- The European Food Safety Authority (EFSA) assesses the safety and efficacy of certain NHPs, while the evaluation of herbal medicinal products falls under the jurisdiction of the European Medicines Agency (EMA).
- The specific requirements for food supplements vary between EU member states, but they generally require compliance with labeling and composition requirements set out in EU regulations.
- Some member states may also require notification or registration of food supplements before they can be placed on the market.
- In India, NHPs, including herbal medicines, dietary supplements, Homeopathic medicine, traditional medicines, and Ayurvedic products are regulated under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
- The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the primary regulatory authority overseeing the regulation of NHPs in India.
- Manufacturers and marketers must obtain licenses, and product labeling must adhere to specific guidelines.
- In Australia, NHPs are regulated as complementary medicines by the Therapeutic Goods Administration (TGA).
- Complementary medicines must be listed or registered with the TGA, depending on the level of evidence for their safety and efficacy.
- Labeling requirements include ingredient lists, dosage instructions, and safety warnings.
- In China, NHPs are regulated by the China Food and Drug Administration (CFDA).
- Different categories of NHPs may be subject to varying levels of regulation.
- Manufacturers must obtain product approvals or registrations before selling NHPs in China.
Natural Health Product (NHP) Licensing
NHP licensing and regulations can vary significantly from one country to another. Different countries have their own regulatory authorities and requirements for licensing NHPs.
Here are the general steps involved in licensing NHPs:
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Determine the Regulatory Authority
Identify the relevant regulatory authority in the country where you want to market and sell your NHPs. This authority is responsible for overseeing the licensing and regulation of such products.
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Product Classification
Understand how NHPs are classified in that country. Different countries may categorize these products differently, such as dietary supplements, herbal medicines, or traditional medicines.
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Compliance with Regulations
Familiarize yourself with the specific regulations and guidelines that apply to NHPs in the target country. These regulations will specify requirements for product safety, quality, labeling, and efficacy.
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Product Formulation and Ingredients
Ensure that your product formulation and ingredients meet the regulatory requirements. This may include restrictions on certain ingredients or maximum allowed dosages.
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Manufacturing Facility Requirements
Ensure that your manufacturing facility complies with Good Manufacturing Practices (GMP) and other relevant quality standards. Compliance with GMP ensures the quality and consistency of your products. Inspections may be conducted by drug regulatory authorities to assess compliance.
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Safety and Efficacy Data
Depending on the country and the claims you wish to make about your NHP, you may need to provide safety and efficacy data. This could include scientific studies, clinical trials, or traditional use evidence.
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Labeling and Packaging Requirements
Ensure that the labeling and packaging of your NHP complies with the guidelines provided by the regulatory authority. Labeling should include details such as the product's ingredients, dosage instructions, safety warnings, manufacturing details and other mandatory information.
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Prepare and Submit Application
Prepare a comprehensive application that includes all required documentation and data. Submit the application to the relevant regulatory authority along with the required fees and supporting documents. Some countries may have an online submission portal.
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Review and Inspection
Regulatory authorities may conduct inspections of your manufacturing facility and review your application and assess the safety, quality, and efficacy of your NHP.
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Approval and Licensing
Once your application is found to be in compliance with the regulations, you may receive approval for the license and will be granted a license to market and sell the product in the target country.
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Post-Market Surveillance
After obtaining the license, you may be required to monitor the safety and quality of your product once it's on the market. This includes reporting adverse events or quality issues to the regulatory authority.
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Post-Approval Compliance with
Ongoing RegulationsOnce NHP licence is granted to you, you need to follow all applicable rules, including those pertaining to labeling, claim substantiation, and ensure compliance with all ongoing regulatory requirements.
It's essential to engage with regulatory experts who are knowledgeable about the specific requirements of the target country and to consult with the relevant regulatory authorities to navigate the licensing process successfully.
NHP Regulations and Licensing in India
Manufacturers and marketers of NHPs in India are required to obtain licenses for their products. These licenses are issued by the State Licensing Authority or the Central Licensing Authority, depending on the scope of operations. The application process typically involves providing detailed information about the product's composition, manufacturing process, safety data, and labeling.
Ayurvedic and Traditional Medicines
Ayurvedic and traditional medicines in India have their own specific regulations and are governed by the Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) and the Ayurvedic, Siddha, and Unani Drugs Consultative Committee (ASUDCC).
Import and Export Regulations
Import and export of NHPs may require licenses and compliance with relevant customs and trade regulations.
How to get NHP Manufacturing License in India ?
The NHP Manufacturing Licensing process in India typically involves several steps. Here are the general steps involved in obtaining a license for NHPs manufacturing:
Based on its components, intended usages, and medicinal claims, determine the category of NHP you intend to manufacture or market. This could include herbal medicines, dietary/ nutritional supplements, Homeopathic medicines, Ayurvedic medicines, or other natural health products.
Assemble and consolidate all pertinent information and documentation regarding your NHP, including information on its components, production process, requirements for product safety, quality, labeling, & efficacy and intended usage.
Ensure that your product formulation and ingredients meet the regulatory requirements. This may include restrictions on certain ingredients or maximum allowed dosages.
Ensure that your manufacturing facility complies with Good Manufacturing Practices (GMP) and other relevant quality standards. Compliance with GMP ensures the quality, safety, efficacy and consistency of your products. Inspections may be conducted by drug regulatory authorities to assess compliance.
For certain categories of NHPs, especially those claiming therapeutic benefits, you may need to establish the product’s safety, quality and efficacy. This may involve providing product composition data, scientific studies, traditional use evidence, clinical trial results, safety and efficacy data depending on the nature of the product.
Ensure that the labeling and packaging of your NHP comply with the guidelines provided by the regulatory authority. Labeling should include details such as the product's ingredients, dosage instructions, directions for use, safety warnings, manufacturing details and other mandatory information. Advertising of NHPs must also adhere to regulatory guidelines and should not make false claims regarding the product's efficacy or therapeutic properties.
This typically includes details about the product, manufacturing facilities, quality control processes, and labeling. All the information and supporting materials for the safety, excellence, and effectiveness of your product should be included in the application.
Submit the license application to the relevant State/ Central Drug Regulatory Authority along with the required fees and supporting documents. The specific authority may depend on the category of NHP and your location.
Regulatory authorities may conduct inspections of your manufacturing facility and review your application and assess the safety, quality, and efficacy of your NHP.
Once your application is found to be in compliance with the regulations, you may receive approval for the license and will be granted a license to market and sell the product in India.
After obtaining the license, you may be required to monitor the safety and quality of product once it's on the market. This includes reporting adverse events or quality issues to the regulatory authority.
Once NHP licence is granted to you, you need to follow all applicable rules, including those pertaining to labeling, claim substantiation, and ensure compliance with all ongoing regulatory requirements.
It is essential to consult the latest guidelines and regulations from the CDSCO and seek legal and regulatory advice to ensure compliance with current licensing requirements when dealing with natural health products in India.
Get Professional Consultancy for NHP Licence in India
Our team of regulatory experts will assist you in navigating the NHP licence process, which involves several key steps:
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Product Classification
Based on the NHP's components, intended usage, and therapeutic claims, we assist you in choosing the most appropriate category. - Product Testing
As mandated by the CDSCO, our staff help you ensure that your NHP goes through extensive safety and efficacy testing.
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Data Compilation
We assemble all required data, including thorough details on the product's ingredients, production procedure, safety record, and intended usage.
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Application Submission
Applying with our assistance, you may confidently submit your NHP registration application, along with the necessary paperwork and payment, to the concerned State Drugs Regulatory Authority.
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Evaluation and approval
Our regulatory professionals walk you through the evaluation procedure and help you ensure that your NHP satisfies all relevant safety and quality requirements.
Compliance with NHP Regulations
Compliance with NHP regulations is of utmost importance to ensure the safety and well-being of consumers. Our services include:
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Labeling Requirements
To ensure that your NHP's package has the necessary product information, dosing directions, and cautionary comments, we help you comply with labeling standards. -
Quality Standards
Our staff help you ensure that your NHP complies with the required quality standards, giving your goods consistency and effectiveness. -
Treatment Claims
We assist you in supporting any treatment claims made for your NHP with appropriate data and scientific support. -
Adverse Event Reporting
We provide you with guidance on how to properly report adverse events so that any occurrences are immediately reported to the relevant regulatory authorities. -
Import and Export Compliance
To ensure seamless transactions, whether you are involved in importing or exporting NHPs, we keep you updated about the pertinent laws and regulations.
Navigating the NHP licensing and regulatory process in India and other countries can be challenging, but you don't have to do it alone. Our team of experienced regulatory consultants is ready to assist you every step of the way.
It is crucial to get professional guidance from our regulatory consultants who are familiar with the regulatory standards and procedures since navigating the NHP licensing process can be difficult. They can help you draft a thorough and complete application, walk you through the full licensing procedure, and help you ensure that your NHP satisfies all requirements for successful licensing.
Contact us today to discuss your NHP registration needs and discover how our tailored solutions can help you bring your natural health products to the Global or Indian market successfully.
Trust us to be your strategic partner in ensuring compliance, safety, and market success for your NHPs in India or other countries.
FAQs
Q1. Is there a universal definition for NHPs worldwide?
No, there is no universal definition for NHPs, and the terminology and categorization may vary by country. Each regulatory authority may have its own criteria for what qualifies as an NHP.
Q2. What is the licensing or approval process for NHPs in different countries?
The licensing or approval process for NHPs varies significantly by country. Some countries have rigorous pre-market approval processes, while others may require post-market surveillance or self-regulation by manufacturers.
Q3. Is it possible to sell NHPs internationally?
Yes, it is possible to sell NHPs internationally, but it requires compliance with the regulations of each target country. This may involve obtaining approvals or licenses in multiple jurisdictions and ensuring that product labeling and marketing comply with target country’s requirements.